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Clinical Psychology Research Paper Topics

This page provides a comprehensive list of clinical psychology research paper topics , designed to support students navigating the complexities of mental health studies. Aimed at fostering a deeper understanding of psychological assessment, therapeutic methods, and the myriad issues faced by individuals with mental health disorders, these topics cover a broad spectrum of areas within clinical psychology. From exploring the efficacy of different therapeutic approaches to examining the impact of cultural and social factors on mental health, this list serves as a vital resource for students seeking to contribute meaningful research to the field. Whether you are interested in the latest trends in neuropsychology, the intricacies of forensic psychology, or the challenges of mental health in children and adolescents, these carefully selected topics offer a rich foundation for your academic inquiries and research endeavors.

100 Clinical Psychology Research Paper Topics

Clinical psychology plays a pivotal role in understanding, diagnosing, and treating mental health issues, standing at the forefront of efforts to improve psychological well-being and quality of life. This field combines rigorous academic research with practical therapeutic applications, making it essential for students to engage with a wide range of topics that reflect the diversity and complexity of human psychology. The topics listed here span foundational theories, cutting-edge therapeutic interventions, and the nuanced interplay between mental health and societal factors, offering students a comprehensive overview of the landscape of clinical psychology.

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• The history and evolution of clinical psychology
• Major theoretical approaches in clinical psychology
• The role of clinical psychology in integrated healthcare
• Ethics in clinical practice and research
• The impact of technology on clinical psychology
• Psychoanalytic theories and techniques
• Cognitive-behavioral therapy: Foundations and evolutions
• The scientist-practitioner model
• Measurement and evaluation in clinical psychology
• Training and professional development in clinical psychology
• Psychological testing and assessment tools
• Neuropsychological testing for cognitive disorders
• Behavioral assessment strategies
• The DSM-5 and diagnostic criteria
• Cultural competence in psychological assessment
• The role of functional assessments in clinical settings
• Innovations in diagnostic methodologies
• Assessing risk and protective factors
• Personality assessment instruments
• Challenges in diagnosing complex cases
• Comparative effectiveness of psychotherapeutic techniques
• Mindfulness and acceptance-based interventions
• The efficacy of short-term psychodynamic therapies
• Innovations in cognitive-behavioral therapy
• Group therapy dynamics and outcomes
• Teletherapy and digital interventions
• Integrative and holistic therapeutic models
• The therapeutic alliance and outcome research
• Psychotherapy for chronic illness
• Ethical considerations in therapeutic practices
• Advances in understanding and treating depression
• Anxiety disorders: Phenomenology and treatment
• Schizophrenia and psychotic disorders
• Personality disorders: Challenges and therapeutic strategies
• Eating disorders: From etiology to recovery
• Bipolar disorder across the lifespan
• Substance use disorders and dual diagnoses
• Post-traumatic stress disorder and trauma-informed care
• Child and adolescent mental health disorders
• The psychology of chronic pain and its management
• Developmental psychopathology
• Behavioral interventions in schools
• Autism spectrum disorders: Diagnosis and intervention
• Adolescent mental health and identity formation
• Parent-child interactions and therapy outcomes
• The impact of technology on youth mental health
• Eating disorders in adolescents
• Childhood anxiety and depression
• ADHD: Contemporary approaches to assessment and treatment
• The role of family therapy in treating childhood disorders
• The brain-behavior relationship
• Cognitive rehabilitation strategies
• Neuroimaging techniques in clinical assessment
• Neuropsychological impacts of neurological disorders
• Aging and cognitive decline
• Pediatric neuropsychology
• Concussions and traumatic brain injury
• The neuropsychology of emotion
• Memory disorders and dementia
• Psychopharmacology for neuropsychological disorders
• The psychology of chronic illness management
• Behavioral interventions for physical health
• Psychoneuroimmunology: Stress and immunity
• Health behavior change models and strategies
• The role of psychology in pain management
• Psychological aspects of cancer care
• The impact of sleep on mental and physical health
• Eating behaviors and nutrition psychology
• The psychology of addiction and substance misuse
• Mind-body interventions in health care
• Psychological assessment in legal contexts
• Competency and insanity evaluations
• The psychology of criminal behavior
• Treatment of offenders and risk assessment
• Victimology and psychological impacts of crime
• Eyewitness testimony and memory reliability
• The role of psychology in law enforcement
• Ethical dilemmas in forensic psychology
• Child custody and family law
• Psychological interventions in correctional settings
• Cross-cultural psychology and mental health
• The impact of socioeconomic status on mental health
• Gender and sexuality issues in clinical psychology
• Racial and ethnic disparities in mental health care
• The psychology of immigration and acculturation
• Indigenous mental health and healing practices
• Stigma and mental illness
• Community psychology and social change
• The role of religion and spirituality in therapy
• Cultural competence in therapeutic settings
• The future of psychotherapy: Trends and predictions
• Virtual reality and augmented reality in therapy
• The use of artificial intelligence in mental health services
• Digital phenotyping and mobile health
• Genomics and personalized medicine in mental health
• Ethical considerations in the use of technology
• The impact of social media on mental health
• Neurofeedback and biofeedback
• E-mental health interventions and apps
• Integrating technology into traditional therapeutic models

The depth and breadth of clinical psychology research paper topics reflect the field’s dynamic nature and its critical role in addressing mental health issues. These topics not only offer students a wealth of areas to explore but also the opportunity to contribute meaningful insights and advancements to the discipline. By delving into these diverse areas of clinical psychology, students can play a part in shaping the future of mental health treatment and understanding, enriching their academic journey and the field at large.

What is Clinical Psychology

Introduction to the Field of Clinical Psychology

Clinical psychology merges the science of psychology with the treatment of complex human problems, making it one of the most critical areas within the realm of psychological study and application. It encompasses a wide range of practices, including assessment, diagnosis, treatment, and prevention of mental disorders. Clinical psychologists employ various therapeutic approaches to treat individuals across the lifespan, dealing with everything from minor stress and life transitions to severe psychopathology.

Importance of Research in Advancing Clinical Practice and Understanding

The bedrock of clinical psychology lies in rigorous research. Research in this field serves multiple purposes: it enhances our understanding of the etiology and progression of mental disorders, evaluates the efficacy of therapeutic interventions, and tests new treatment approaches. Without research, clinical practice would lack the empirical basis necessary for effectively treating patients. Research ensures that clinical interventions are both safe and effective, thereby safeguarding the well-being of clients and advancing the field.

Exploration of Diverse Research Topics in Clinical Psychology

Research in clinical psychology is as diverse as the field itself, covering a wide array of topics that reflect the complexity of human behavior and mental health. These topics range from understanding the neurological underpinnings of mental disorders to exploring the effectiveness of new psychotherapeutic techniques. Research in this field also investigates the social, cultural, and environmental factors that influence mental health, thereby contributing to more holistic approaches to treatment and prevention. This diversity not only broadens the scope of clinical psychology but also ensures that the field remains responsive to the changing needs of society.

Recent Advancements and Innovations in Clinical Psychology Research

The field of clinical psychology has witnessed significant advancements and innovations, thanks in part to technological progress and a deeper understanding of psychological processes. Recent research has explored the potential of teletherapy, digital interventions, and mobile health applications, providing access to mental health services for individuals who might otherwise face barriers to treatment. Additionally, advances in neuroimaging and psychopharmacology have offered new insights into the biological aspects of mental disorders, leading to more targeted and effective treatments. These advancements underscore the dynamic nature of clinical psychology and its continuous evolution in response to scientific discoveries and societal changes.

Ethical Considerations in Clinical Psychology Research

Ethical considerations hold paramount importance in clinical psychology research, given the vulnerability of the populations often involved. Ethical guidelines ensure that research is conducted in a manner that respects the dignity, rights, and welfare of participants. This includes obtaining informed consent, ensuring confidentiality, and minimizing potential harm. Ethical research practices are crucial for maintaining trust between researchers and participants and for upholding the integrity of the field.

Future Directions for Research in Clinical Psychology

Looking ahead, the field of clinical psychology is poised to explore new frontiers that promise to further enhance our understanding of mental health and improve treatment outcomes. One area of future research may focus on personalized medicine, tailoring interventions to the unique genetic, biological, and environmental factors of each individual. Another promising area involves integrating clinical psychology more closely with other disciplines, such as neuroscience and public health, to develop more comprehensive and effective approaches to mental health care. Additionally, as society continues to evolve, ongoing research will be necessary to address the psychological impacts of emerging societal challenges.

The Impact of Research on the Evolution of Clinical Psychology Practices

The trajectory of clinical psychology is indelibly shaped by research. It is through the diligent efforts of researchers that the field continues to advance, offering new insights into the human psyche and more effective treatments for mental disorders. Research in clinical psychology not only enriches our understanding of mental health but also plays a critical role in shaping policies, therapeutic practices, and public perceptions of mental health issues. As we move forward, the continued emphasis on research will ensure that clinical psychology remains a vital force for good in the lives of individuals and communities worldwide, epitomizing the profound impact that research has on the evolution of clinical practices.

iResearchNet’s Writing Services

At iResearchNet, we recognize the unique challenges and complexities involved in crafting research papers within the field of clinical psychology. That’s why we offer specialized writing services tailored specifically for clinical psychology students and professionals. Our mission is to support your academic and research endeavors by providing custom, high-quality papers that reflect the latest advancements and ethical considerations in clinical psychology. Whether you’re exploring novel therapeutic interventions, dissecting complex case studies, or examining the societal impact of mental health issues, iResearchNet is your partner in navigating the intricacies of clinical psychology research.

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At iResearchNet, our dedication to supporting students and professionals in their clinical psychology research endeavors is unwavering. We understand the critical importance of your academic and professional contributions to the field of clinical psychology. By providing high-quality, customized research papers, we aim to help you advance your academic journey and make meaningful contributions to the field. Choose iResearchNet for your clinical psychology research paper needs and experience the difference that professional, tailored writing services can make in achieving academic excellence.

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Embark on a path of academic distinction in the field of clinical psychology with iResearchNet at your side. Our expert writing services are meticulously designed to cater to your unique research paper needs, empowering you to delve deeper into the complexities of mental health and therapeutic practices. Whether you’re tackling the intricacies of psychological assessments, exploring innovative therapeutic approaches, or analyzing the societal implications of mental health policies, our custom research papers are your gateway to academic excellence.

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Don’t let the opportunity to elevate your academic and professional prospects pass you by. Choose iResearchNet for your clinical psychology research paper needs and step confidently into your future, armed with insights and knowledge that will distinguish your work in the field. Your journey towards academic and professional excellence in clinical psychology begins here, with iResearchNet’s commitment to providing you with top-quality, customized research papers.

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10 Clinical Psychology Research Topics to Explore

Whether you’re working toward a PsyD or a PhD in Clinical Psychology , landing on a research paper that will sustain your interest throughout your doctoral program can be both thrilling and challenging.

Should you go with a niche you know well or branch out to another psychology specialization ? Should you choose a research topic you’re passionate about or opt for something more topical and needed in the broader realm of behavioral and mental health?

Only you can answer these questions—however, this blog may provide you with some inspiration and direction. Let’s walk through 10 of the most fascinating clinical psychology research topics and how they might bring you closer to your educational and professional objectives.

Explore Clinical Psychology Programs

10 Emerging Research Topics in Clinical Psychology

One of the benefits of clinical psychology is that it’s far from a static field.

With each passing year, we gain more and more insight into the brain and how it affects behavior. In the last few years alone, for example, we’ve obtained a clearer picture of the negative effects of digital media on mental health and behavior. But we’ve also seen how digital media (specifically, mobile apps) can enhance mental health when used correctly. 1

Put simply, clinical psychology is a dynamic, exhilarating realm with seemingly boundless possibilities for further research.

Nonetheless, it’s easy to feel overwhelmed when settling on a clinical psychology research paper topic, especially when it’s one that you may be intimate with for years. To that end, consider these top 10 psychology topics to get you started in your research area:

#1. Mental Health Technology and Digital Interventions

The pandemic dramatically altered how healthcare practitioners interact with their patients and clients. Whereas psychotherapy and other forms of counseling were once performed almost exclusively in person, COVID-19 turned mental telehealth into our new reality.

But what might the long-term effects of this be? And will it persist as we march into the future?

Exploring the impact of digital mental health interventions (such as apps, other digital tools, and teleconferences) on well-being may open up a world of possible clinical psychology research topics and questions. 2 For instance, it may compel you to ask and research thoughts like:

• How will AI alter mental health treatments, if at all?
• Will digital mental health interventions ultimately cause or worsen isolation?
• What are the downsides and perks of turning to social media for mental health information?
• What is the relevance and value of in-person counseling sessions, post-pandemic?
• Do clients feel safer in online sessions?
• How can technology be employed to monitor patients outside of sessions?
• How does mental telehealth affect the elderly?

Technology is rapidly and constantly changing. In other words, psychology and technology may be exciting subjects to explore as you work towards starting or completing your doctorate.

#2. Cross-Cultural and Global Mental Health 

Globalization has its pros and cons. Studies indicate that while it may have its advantages, it can also heighten: 4

• Discrimination

Each of these may have lasting effects, including increasing the risk of mental disorders like addiction, depression, and anxiety. In other words, it needs to be examined by experts from multiple standpoints.

As a doctoral student, you’re in an ideal spot to investigate this complex issue. It also emphasizes the need to gain cultural competency and a global mindset as a mental health practitioner, which is another possible research topic in and of itself.

#3. Neuropsychology and Cognitive Processes

The field of neuropsychology and cognitive processes continues to grow, particularly with the advent of digital tools and their ability to monitor cognition. 5 Exploring our advancing knowledge of how the brain affects behavior may allow you to look at a wide range of mental health disorders and the newest clinical interventions that are being made available, such as treating:

• Alcohol use disorder (AUD)
• Eating disorders
• Post-traumatic stress disorder (PTSD)

#4. Trauma and Resilience Studies

Psychologists and psychiatrists ranging from Bessel Van der Kolk to Peter Levine forever altered our understanding of trauma. What was once thought of as a purely psychological issue is now understood as a bodily ailment. 6

But how might this look as we move forward in time and gain an enhanced understanding of neuroplasticity? Will somatics continue to play a role in treating trauma, or will technological advances send practitioners and their clients in a completely different direction?

You may be in a position to dig deeper and find out.

#5. Behavioral Health and Chronic Conditions

The unique relationship between chronic conditions and behavioral health is also up for exploration. Growing research indicates that chronic conditions (such as diabetes) can trigger mental health complications like depression, which can then perpetuate the cycle of the chronic condition.

This topic may be especially timely and relevant as it emphasizes the need to bridge the gap between a patient’s full healthcare team and points out flaws in treating chronic conditions solely from a pharmaceutical stance.

#6. Psychotherapy Process and Outcome Research

Cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and other forms of traditional “talk therapy” have been mainstays in the field of clinical psychology for decades. But this, too, isn’t static, especially as clients continue to look more toward body-based therapies and technology-fueled solutions, like: 8

• Transcranial magnetic stimulation (TMS)
• Neurofeedback therapy 
• Brainspotting
• Somatic Experiencing (SE)

Is it too soon to know if these and other fresh forms of mental health treatments have the same staying power as, say, cognitive behavioral therapy? This might be optimal for exploration.

#7. Social Determinants of Mental Health 

Social determinants of mental health (SDOMH) refer to the external circumstances that may impact an individual’s mental well-being and make them more vulnerable to conditions ranging from depression to addiction. SDOMH includes: 9

• Unemployment 
• Social isolation
• Urban crowding

How will SDOMH change as we move forward? Will it? Additionally, what is a clinical psychologist’s role in addressing these issues? What are the most effective strategies for working with those who have been disadvantaged?

This is an important topic as we, as a society, continue to address long-buried issues of race and class.

#8. Addiction and Substance Use Disorders

Addiction remains a prevalent topic: Alcohol use disorder (AUD) affects roughly 10.5% of the population, while 46.8 million Americans wrestled with a substance abuse disorder in 2022 alone. 10

Analyzing the most recent treatments and the future of treatments might not only pave the way for your own work after completion of your PsyD or PhD but also do a tremendous service for those who suffer from addiction (and their loved ones and families).

#9. Child and Adolescent Mental Health

Numerous studies indicate that kids and teens now have unusually high rates of: 11

• Substance use

What plays into this? Is social media entirely to blame, or can social sites also be a resource for youngsters? And how can clinical psychologists tweak their methods to resonate with kids and teens?

These are just three of the many questions you might ask if you decide to adopt this topic for your clinical research.

#10. Ethics and Professional Issues in Clinical Psychology

Last but not least, consider the value of examining both the main and more subtle ethics and professional issues in clinical psychology at work today, such as:

• Privacy 
• Informed consent
• Cultural sensitivity 
• Termination of counseling

Shape the Future of Mental Health with Alliant International University 

From making a substantial difference in the lives of others to eradicating the stigmas that surround certain mental health conditions, clinical psychologists are in a prime position to fuel lasting change. Selecting a clinical research topic that ignites your spirit and works toward solving larger social issues takes this notion to the next level.

Alliant International University may get you closer to becoming the type of clinical psychologist who can make an impact. Whether you’re exploring our PsyD in Clinical Psychology or have just started college, we’re proud to offer doctoral programs for psychology that can help you excel in your future profession. And with online and in-person classes and training, you might find the flexibility your life requires.

Learn more about our clinical psychology programs today.

Sources: 

• “Exploring the Latest Frontiers in Clinical Psychology Research.” The Clinic, March 25, 2024. https://theclinicca.org/exploring-the-latest-frontiers-in-clinical-psyc… .
•  Park, Susanna Y, Chloe Nicksic Sigmon, and Debra Boeldt. “A Framework for the Implementation of Digital Mental Health Interventions: The Importance of Feasibility and Acceptability Research.” Cureus, September 19, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9580609/.  
• Bond, Raymond R., Maurice D. Mulvenna, Courtney Potts, Siobhan O’Neill, Edel Ennis, and John Torous. “Digital Transformation of Mental Health Services.” Nature News, August 22, 2023. https://www.nature.com/articles/s44184-023-00033-y.  
• “Cross-Cultural Mental Health.” CMHA British Columbia, July 14, 2016. https://bc.cmha.ca/documents/cross-cultural-mental-health-and-substance-use-2/.  
• “New Research Looks at the Promise of ‘Digital Neuropsychology.’” McLean News | New Research Looks at the Promise of “Digital Neuropsychology,” January 7, 2019. https://www.mcleanhospital.org/news/new-research-looks-promise-digital-neuropsychology.  
• Kuhfuß, Marie, Tobias Maldei, Andreas Hetmanek, and Nicola Baumann. “Somatic Experiencing - Effectiveness and Key Factors of a Body-Oriented Trauma Therapy: A Scoping Literature Review.” European journal of psychotraumatology, July 12, 2021. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276649/.  
• “The Intersection of Mental Health and Chronic Disease.” Johns Hopkins Bloomberg School of Public Health. Accessed April 17, 2024. https://publichealth.jhu.edu/2021/the-intersection-of-mental-health-and-chronic-disease.  
• Theodora Blanchfield, AMFT. “What to Know about Brainspotting Therapy.” Verywell Mind, January 16, 2024. https://www.verywellmind.com/brainspotting-therapy-definition-techniques-and-efficacy-5213947.  
• Social Determinants of Health and Mental Health. Accessed April 17, 2024. https://www.ncsc.org/__data/assets/pdf_file/0025/70864/Social-Determinants-of-Health.pdf.  
• “Alcohol and Drug Abuse Statistics (Facts about Addiction).” American Addiction Centers, April 4, 2024. https://americanaddictioncenters.org/addiction-statistics#.  
• “Data and Statistics on Children’s Mental Health.” Centers for Disease Control and Prevention, March 8, 2023. https://www.cdc.gov/childrensmentalhealth/data.html.  

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

61 intriguing psychology research topics to explore

Last updated

11 January 2024

Reviewed by

Brittany Ferri, PhD, OTR/L

Short on time? Get an AI generated summary of this article instead

Psychology is an incredibly diverse, critical, and ever-changing area of study in the medical and health industries. Because of this, it’s a common area of study for students and healthcare professionals.

We’re walking you through picking the perfect topic for your upcoming paper or study. Keep reading for plenty of example topics to pique your interest and curiosity.

• How to choose a psychology research topic

Exploring a psychology-based topic for your research project? You need to pick a specific area of interest to collect compelling data. 

Use these tips to help you narrow down which psychology topics to research:

Focus on a particular area of psychology

The most effective psychological research focuses on a smaller, niche concept or disorder within the scope of a study. 

Psychology is a broad and fascinating area of science, including everything from diagnosed mental health disorders to sports performance mindset assessments. 

This gives you plenty of different avenues to explore. Having a hard time choosing? Check out our list of 61 ideas further down in this article to get started.

Read the latest clinical studies

Once you’ve picked a more niche topic to explore, you need to do your due diligence and explore other research projects on the same topic. 

This practice will help you learn more about your chosen topic, ask more specific questions, and avoid covering existing projects. 

For the best results, we recommend creating a research folder of associated published papers to reference throughout your project. This makes it much easier to cite direct references and find inspiration down the line.

Find a topic you enjoy and ask questions

Once you’ve spent time researching and collecting references for your study, you finally get to explore. 

Whether this research project is for work, school, or just for fun, having a passion for your research will make the project much more enjoyable. (Trust us, there will be times when that is the only thing that keeps you going.) 

Now you’ve decided on the topic, ask more nuanced questions you might want to explore. 

If you can, pick the direction that interests you the most to make the research process much more enjoyable.

• 61 psychology topics to research in 2024

Need some extra help starting your psychology research project on the right foot? Explore our list of 61 cutting-edge, in-demand psychology research topics to use as a starting point for your research journey.

• Psychology research topics for university students

As a university student, it can be hard to pick a research topic that fits the scope of your classes and is still compelling and unique. 

Here are a few exciting topics we recommend exploring for your next assigned research project:

Mental health in post-secondary students

Seeking post-secondary education is a stressful and overwhelming experience for most students, making this topic a great choice to explore for your in-class research paper. 

Examples of post-secondary mental health research topics include:

Student mental health status during exam season

Mental health disorder prevalence based on study major

The impact of chronic school stress on overall quality of life

The impacts of cyberbullying

Cyberbullying can occur at all ages, starting as early as elementary school and carrying through into professional workplaces. 

Examples of cyberbullying-based research topics you can study include:

The impact of cyberbullying on self-esteem

Common reasons people engage in cyberbullying 

Cyberbullying themes and commonly used terms

Cyberbullying habits in children vs. adults

The long-term effects of cyberbullying

• Clinical psychology research topics

If you’re looking to take a more clinical approach to your next project, here are a few topics that involve direct patient assessment for you to consider:

Chronic pain and mental health

Living with chronic pain dramatically impacts every aspect of a person’s life, including their mental and emotional health. 

Here are a few examples of in-demand pain-related psychology research topics:

The connection between diabetic neuropathy and depression

Neurological pain and its connection to mental health disorders

Efficacy of meditation and mindfulness for pain management

The long-term effects of insomnia

Insomnia is where you have difficulty falling or staying asleep. It’s a common health concern that impacts millions of people worldwide. 

This is an excellent topic because insomnia can have a variety of causes, offering many research possibilities. 

Here are a few compelling psychology research topics about insomnia you could investigate:

The prevalence of insomnia based on age, gender, and ethnicity

Insomnia and its impact on workplace productivity

The connection between insomnia and mental health disorders

Efficacy and use of melatonin supplements for insomnia

The risks and benefits of prescription insomnia medications

Lifestyle options for managing insomnia symptoms

The efficacy of mental health treatment options

Management and treatment of mental health conditions is an ever-changing area of study. If you can witness or participate in mental health therapies, this can make a great research project. 

Examples of mental health treatment-related psychology research topics include:

The efficacy of cognitive behavioral therapy (CBT) for patients with severe anxiety

The benefits and drawbacks of group vs. individual therapy sessions

Music therapy for mental health disorders

Electroconvulsive therapy (ECT) for patients with depression 

• Controversial psychology research paper topics

If you are looking to explore a more cutting-edge or modern psychology topic, you can delve into a variety of controversial and topical options:

The impact of social media and digital platforms

Ever since access to internet forums and video games became more commonplace, there’s been growing concern about the impact these digital platforms have on mental health. 

Examples of social media and video game-related psychology research topics include:

The effect of edited images on self-confidence

How social media platforms impact social behavior

Video games and their impact on teenage anger and violence

Digital communication and the rapid spread of misinformation

The development of digital friendships

Psychotropic medications for mental health

In recent years, the interest in using psychoactive medications to treat and manage health conditions has increased despite their inherently controversial nature. 

Examples of psychotropic medication-related research topics include:

The risks and benefits of using psilocybin mushrooms for managing anxiety

The impact of marijuana on early-onset psychosis

Childhood marijuana use and related prevalence of mental health conditions

Ketamine and its use for complex PTSD (C-PTSD) symptom management

The effect of long-term psychedelic use and mental health conditions

• Mental health disorder research topics

As one of the most popular subsections of psychology, studying mental health disorders and how they impact quality of life is an essential and impactful area of research. 

While studies in these areas are common, there’s always room for additional exploration, including the following hot-button topics:

Anxiety and depression disorders

Anxiety and depression are well-known and heavily researched mental health disorders. 

Despite this, we still don’t know many things about these conditions, making them great candidates for psychology research projects:

Social anxiety and its connection to chronic loneliness

C-PTSD symptoms and causes

The development of phobias

Obsessive-compulsive disorder (OCD) behaviors and symptoms

Depression triggers and causes

Self-care tools and resources for depression

The prevalence of anxiety and depression in particular age groups or geographic areas

Bipolar disorder

Bipolar disorder is a complex and multi-faceted area of psychology research. 

Use your research skills to learn more about this condition and its impact by choosing any of the following topics:

Early signs of bipolar disorder

The incidence of bipolar disorder in young adults

The efficacy of existing bipolar treatment options

Bipolar medication side effects

Cognitive behavioral therapy for people with bipolar 

Schizoaffective disorder

Schizoaffective disorder is often stigmatized, and less common mental health disorders are a hotbed for new and exciting research. 

Here are a few examples of interesting research topics related to this mental health disorder:

The prevalence of schizoaffective disorder by certain age groups or geographic locations

Risk factors for developing schizoaffective disorder

The prevalence and content of auditory and visual hallucinations

Alternative therapies for schizoaffective disorder

• Societal and systematic psychology research topics

Modern society’s impact is deeply enmeshed in our mental and emotional health on a personal and community level. 

Here are a few examples of societal and systemic psychology research topics to explore in more detail:

Access to mental health services

While mental health awareness has risen over the past few decades, access to quality mental health treatment and resources is still not equitable. 

This can significantly impact the severity of a person’s mental health symptoms, which can result in worse health outcomes if left untreated. 

Explore this crucial issue and provide information about the need for improved mental health resource access by studying any of the following topics:

Rural vs. urban access to mental health resources

Access to crisis lines by location

Wait times for emergency mental health services

Inequities in mental health access based on income and location

Insurance coverage for mental health services

Systemic racism and mental health

Societal systems and the prevalence of systemic racism heavily impact every aspect of a person’s overall health.

Researching these topics draws attention to existing problems and contributes valuable insights into ways to improve access to care moving forward.

Examples of systemic racism-related psychology research topics include: 

Access to mental health resources based on race

The prevalence of BIPOC mental health therapists in a chosen area

The impact of systemic racism on mental health and self-worth

Racism training for mental health workers

The prevalence of mental health disorders in discriminated groups

LGBTQIA+ mental health concerns

Research about LGBTQIA+ people and their mental health needs is a unique area of study to explore for your next research project. It’s a commonly overlooked and underserved community.

Examples of LGBTQIA+ psychology research topics to consider include:

Mental health supports for queer teens and children

The impact of queer safe spaces on mental health

The prevalence of mental health disorders in the LGBTQIA+ community

The benefits of queer mentorship and found family

Substance misuse in LQBTQIA+ youth and adults

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A clinical trial involves the study of the safety, efficacy and/or dosage regimen of a therapeutic intervention (such as a drug) in humans selected according to predetermined criteria of eligibility (such as a defined severity of a specific disease), who are observed for predefined evidence of favourable and unfavourable effects.

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Research Topics & Ideas: Healthcare

F inding and choosing a strong research topic is the critical first step when it comes to crafting a high-quality dissertation, thesis or research project. If you’ve landed on this post, chances are you’re looking for a healthcare-related research topic , but aren’t sure where to start. Here, we’ll explore a variety of healthcare-related research ideas and topic thought-starters across a range of healthcare fields, including allopathic and alternative medicine, dentistry, physical therapy, optometry, pharmacology and public health.

NB – This is just the start…

The topic ideation and evaluation process has multiple steps . In this post, we’ll kickstart the process by sharing some research topic ideas within the healthcare domain. This is the starting point, but to develop a well-defined research topic, you’ll need to identify a clear and convincing research gap , along with a well-justified plan of action to fill that gap.

If you’re new to the oftentimes perplexing world of research, or if this is your first time undertaking a formal academic research project, be sure to check out our free dissertation mini-course. In it, we cover the process of writing a dissertation or thesis from start to end. Be sure to also sign up for our free webinar that explores how to find a high-quality research topic.

Overview: Healthcare Research Topics

• Allopathic medicine
• Alternative /complementary medicine
• Veterinary medicine
• Physical therapy/ rehab
• Optometry and ophthalmology
• Pharmacy and pharmacology
• Public health
• Examples of healthcare-related dissertations

Allopathic (Conventional) Medicine

• The effectiveness of telemedicine in remote elderly patient care
• The impact of stress on the immune system of cancer patients
• The effects of a plant-based diet on chronic diseases such as diabetes
• The use of AI in early cancer diagnosis and treatment
• The role of the gut microbiome in mental health conditions such as depression and anxiety
• The efficacy of mindfulness meditation in reducing chronic pain: A systematic review
• The benefits and drawbacks of electronic health records in a developing country
• The effects of environmental pollution on breast milk quality
• The use of personalized medicine in treating genetic disorders
• The impact of social determinants of health on chronic diseases in Asia
• The role of high-intensity interval training in improving cardiovascular health
• The efficacy of using probiotics for gut health in pregnant women
• The impact of poor sleep on the treatment of chronic illnesses
• The role of inflammation in the development of chronic diseases such as lupus
• The effectiveness of physiotherapy in pain control post-surgery

Topics & Ideas: Alternative Medicine

• The benefits of herbal medicine in treating young asthma patients
• The use of acupuncture in treating infertility in women over 40 years of age
• The effectiveness of homoeopathy in treating mental health disorders: A systematic review
• The role of aromatherapy in reducing stress and anxiety post-surgery
• The impact of mindfulness meditation on reducing high blood pressure
• The use of chiropractic therapy in treating back pain of pregnant women
• The efficacy of traditional Chinese medicine such as Shun-Qi-Tong-Xie (SQTX) in treating digestive disorders in China
• The impact of yoga on physical and mental health in adolescents
• The benefits of hydrotherapy in treating musculoskeletal disorders such as tendinitis
• The role of Reiki in promoting healing and relaxation post birth
• The effectiveness of naturopathy in treating skin conditions such as eczema
• The use of deep tissue massage therapy in reducing chronic pain in amputees
• The impact of tai chi on the treatment of anxiety and depression
• The benefits of reflexology in treating stress, anxiety and chronic fatigue
• The role of acupuncture in the prophylactic management of headaches and migraines

Topics & Ideas: Dentistry

• The impact of sugar consumption on the oral health of infants
• The use of digital dentistry in improving patient care: A systematic review
• The efficacy of orthodontic treatments in correcting bite problems in adults
• The role of dental hygiene in preventing gum disease in patients with dental bridges
• The impact of smoking on oral health and tobacco cessation support from UK dentists
• The benefits of dental implants in restoring missing teeth in adolescents
• The use of lasers in dental procedures such as root canals
• The efficacy of root canal treatment using high-frequency electric pulses in saving infected teeth
• The role of fluoride in promoting remineralization and slowing down demineralization
• The impact of stress-induced reflux on oral health
• The benefits of dental crowns in restoring damaged teeth in elderly patients
• The use of sedation dentistry in managing dental anxiety in children
• The efficacy of teeth whitening treatments in improving dental aesthetics in patients with braces
• The role of orthodontic appliances in improving well-being
• The impact of periodontal disease on overall health and chronic illnesses

Topics & Ideas: Veterinary Medicine

• The impact of nutrition on broiler chicken production
• The role of vaccines in disease prevention in horses
• The importance of parasite control in animal health in piggeries
• The impact of animal behaviour on welfare in the dairy industry
• The effects of environmental pollution on the health of cattle
• The role of veterinary technology such as MRI in animal care
• The importance of pain management in post-surgery health outcomes
• The impact of genetics on animal health and disease in layer chickens
• The effectiveness of alternative therapies in veterinary medicine: A systematic review
• The role of veterinary medicine in public health: A case study of the COVID-19 pandemic
• The impact of climate change on animal health and infectious diseases in animals
• The importance of animal welfare in veterinary medicine and sustainable agriculture
• The effects of the human-animal bond on canine health
• The role of veterinary medicine in conservation efforts: A case study of Rhinoceros poaching in Africa
• The impact of veterinary research of new vaccines on animal health

Topics & Ideas: Physical Therapy/Rehab

• The efficacy of aquatic therapy in improving joint mobility and strength in polio patients
• The impact of telerehabilitation on patient outcomes in Germany
• The effect of kinesiotaping on reducing knee pain and improving function in individuals with chronic pain
• A comparison of manual therapy and yoga exercise therapy in the management of low back pain
• The use of wearable technology in physical rehabilitation and the impact on patient adherence to a rehabilitation plan
• The impact of mindfulness-based interventions in physical therapy in adolescents
• The effects of resistance training on individuals with Parkinson’s disease
• The role of hydrotherapy in the management of fibromyalgia
• The impact of cognitive-behavioural therapy in physical rehabilitation for individuals with chronic pain
• The use of virtual reality in physical rehabilitation of sports injuries
• The effects of electrical stimulation on muscle function and strength in athletes
• The role of physical therapy in the management of stroke recovery: A systematic review
• The impact of pilates on mental health in individuals with depression
• The use of thermal modalities in physical therapy and its effectiveness in reducing pain and inflammation
• The effect of strength training on balance and gait in elderly patients

Need a helping hand?

Topics & Ideas: Optometry & Opthalmology

• The impact of screen time on the vision and ocular health of children under the age of 5
• The effects of blue light exposure from digital devices on ocular health
• The role of dietary interventions, such as the intake of whole grains, in the management of age-related macular degeneration
• The use of telemedicine in optometry and ophthalmology in the UK
• The impact of myopia control interventions on African American children’s vision
• The use of contact lenses in the management of dry eye syndrome: different treatment options
• The effects of visual rehabilitation in individuals with traumatic brain injury
• The role of low vision rehabilitation in individuals with age-related vision loss: challenges and solutions
• The impact of environmental air pollution on ocular health
• The effectiveness of orthokeratology in myopia control compared to contact lenses
• The role of dietary supplements, such as omega-3 fatty acids, in ocular health
• The effects of ultraviolet radiation exposure from tanning beds on ocular health
• The impact of computer vision syndrome on long-term visual function
• The use of novel diagnostic tools in optometry and ophthalmology in developing countries
• The effects of virtual reality on visual perception and ocular health: an examination of dry eye syndrome and neurologic symptoms

Topics & Ideas: Pharmacy & Pharmacology

• The impact of medication adherence on patient outcomes in cystic fibrosis
• The use of personalized medicine in the management of chronic diseases such as Alzheimer’s disease
• The effects of pharmacogenomics on drug response and toxicity in cancer patients
• The role of pharmacists in the management of chronic pain in primary care
• The impact of drug-drug interactions on patient mental health outcomes
• The use of telepharmacy in healthcare: Present status and future potential
• The effects of herbal and dietary supplements on drug efficacy and toxicity
• The role of pharmacists in the management of type 1 diabetes
• The impact of medication errors on patient outcomes and satisfaction
• The use of technology in medication management in the USA
• The effects of smoking on drug metabolism and pharmacokinetics: A case study of clozapine
• Leveraging the role of pharmacists in preventing and managing opioid use disorder
• The impact of the opioid epidemic on public health in a developing country
• The use of biosimilars in the management of the skin condition psoriasis
• The effects of the Affordable Care Act on medication utilization and patient outcomes in African Americans

Topics & Ideas: Public Health

• The impact of the built environment and urbanisation on physical activity and obesity
• The effects of food insecurity on health outcomes in Zimbabwe
• The role of community-based participatory research in addressing health disparities
• The impact of social determinants of health, such as racism, on population health
• The effects of heat waves on public health
• The role of telehealth in addressing healthcare access and equity in South America
• The impact of gun violence on public health in South Africa
• The effects of chlorofluorocarbons air pollution on respiratory health
• The role of public health interventions in reducing health disparities in the USA
• The impact of the United States Affordable Care Act on access to healthcare and health outcomes
• The effects of water insecurity on health outcomes in the Middle East
• The role of community health workers in addressing healthcare access and equity in low-income countries
• The impact of mass incarceration on public health and behavioural health of a community
• The effects of floods on public health and healthcare systems
• The role of social media in public health communication and behaviour change in adolescents

Examples: Healthcare Dissertation & Theses

While the ideas we’ve presented above are a decent starting point for finding a healthcare-related research topic, they are fairly generic and non-specific. So, it helps to look at actual dissertations and theses to see how this all comes together.

Below, we’ve included a selection of research projects from various healthcare-related degree programs to help refine your thinking. These are actual dissertations and theses, written as part of Master’s and PhD-level programs, so they can provide some useful insight as to what a research topic looks like in practice.

• Improving Follow-Up Care for Homeless Populations in North County San Diego (Sanchez, 2021)
• On the Incentives of Medicare’s Hospital Reimbursement and an Examination of Exchangeability (Elzinga, 2016)
• Managing the healthcare crisis: the career narratives of nurses (Krueger, 2021)
• Methods for preventing central line-associated bloodstream infection in pediatric haematology-oncology patients: A systematic literature review (Balkan, 2020)
• Farms in Healthcare: Enhancing Knowledge, Sharing, and Collaboration (Garramone, 2019)
• When machine learning meets healthcare: towards knowledge incorporation in multimodal healthcare analytics (Yuan, 2020)
• Integrated behavioural healthcare: The future of rural mental health (Fox, 2019)
• Healthcare service use patterns among autistic adults: A systematic review with narrative synthesis (Gilmore, 2021)
• Mindfulness-Based Interventions: Combatting Burnout and Compassionate Fatigue among Mental Health Caregivers (Lundquist, 2022)
• Transgender and gender-diverse people’s perceptions of gender-inclusive healthcare access and associated hope for the future (Wille, 2021)
• Efficient Neural Network Synthesis and Its Application in Smart Healthcare (Hassantabar, 2022)
• The Experience of Female Veterans and Health-Seeking Behaviors (Switzer, 2022)
• Machine learning applications towards risk prediction and cost forecasting in healthcare (Singh, 2022)
• Does Variation in the Nursing Home Inspection Process Explain Disparity in Regulatory Outcomes? (Fox, 2020)

Looking at these titles, you can probably pick up that the research topics here are quite specific and narrowly-focused , compared to the generic ones presented earlier. This is an important thing to keep in mind as you develop your own research topic. That is to say, to create a top-notch research topic, you must be precise and target a specific context with specific variables of interest . In other words, you need to identify a clear, well-justified research gap.

Find The Perfect Research Topic

How To Choose A Research Topic: 5 Key Criteria

How To Choose A Research Topic Step-By-Step Tutorial With Examples + Free Topic...

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Research Topics & Ideas: Robotics 50 Topic Ideas To Kickstart Your Research...

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Research Topics & Ideas: Sociology 50 Topic Ideas To Kickstart Your Research...

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Research Topics & Ideas: Public Health 50 Topic Ideas To Kickstart Your Research...

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Research Topics & Ideas: Neuroscience 50 Topic Ideas To Kickstart Your Research...

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18 Comments

I need topics that will match the Msc program am running in healthcare research please

Hello Mabel,

I can help you with a good topic, kindly provide your email let’s have a good discussion on this.

Can you provide some research topics and ideas on Immunology?

Thank you to create new knowledge on research problem verse research topic

Help on problem statement on teen pregnancy

This post might be useful: https://gradcoach.com/research-problem-statement/

can you give me research titles that i can conduct as a school nurse

can you provide me with a research topic on healthcare related topics to a qqi level 5 student

Please can someone help me with research topics in public health ?

Hello I have requirement of Health related latest research issue/topics for my social media speeches. If possible pls share health issues , diagnosis, treatment.

I would like a topic thought around first-line support for Gender-Based Violence for survivors or one related to prevention of Gender-Based Violence

Please can I be helped with a master’s research topic in either chemical pathology or hematology or immunology? thanks

Can u please provide me with a research topic on occupational health and safety at the health sector

Good day kindly help provide me with Ph.D. Public health topics on Reproductive and Maternal Health, interventional studies on Health Education

may you assist me with a good easy healthcare administration study topic

May you assist me in finding a research topic on nutrition,physical activity and obesity. On the impact on children

I have been racking my brain for a while on what topic will be suitable for my PhD in health informatics. I want a qualitative topic as this is my strong area.

Hi, may I please be assisted with research topics in the medical laboratory sciences

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50+ Research Topics for Psychology Papers

How to Find Psychology Research Topics for Your Student Paper

• Specific Branches of Psychology
• Topics Involving a Disorder or Type of Therapy
• Human Cognition
• Human Development
• Critique of Publications
• Famous Experiments
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Are you searching for a great topic for your psychology paper ? Sometimes it seems like coming up with topics of psychology research is more challenging than the actual research and writing. Fortunately, there are plenty of great places to find inspiration and the following list contains just a few ideas to help get you started.

Finding a solid topic is one of the most important steps when writing any type of paper. It can be particularly important when you are writing a psychology research paper or essay. Psychology is such a broad topic, so you want to find a topic that allows you to adequately cover the subject without becoming overwhelmed with information.

I can always tell when a student really cares about the topic they chose; it comes through in the writing. My advice is to choose a topic that genuinely interests you, so you’ll be more motivated to do thorough research.

In some cases, such as in a general psychology class, you might have the option to select any topic from within psychology's broad reach. Other instances, such as in an  abnormal psychology  course, might require you to write your paper on a specific subject such as a psychological disorder.

As you begin your search for a topic for your psychology paper, it is first important to consider the guidelines established by your instructor.

Research Topics Within Specific Branches of Psychology

The key to selecting a good topic for your psychology paper is to select something that is narrow enough to allow you to really focus on the subject, but not so narrow that it is difficult to find sources or information to write about.

One approach is to narrow your focus down to a subject within a specific branch of psychology. For example, you might start by deciding that you want to write a paper on some sort of social psychology topic. Next, you might narrow your focus down to how persuasion can be used to influence behavior .

Other social psychology topics you might consider include:

• Prejudice and discrimination (i.e., homophobia, sexism, racism)
• Social cognition
• Person perception
• Social control and cults
• Persuasion, propaganda, and marketing
• Attraction, romance, and love
• Nonverbal communication
• Prosocial behavior

Psychology Research Topics Involving a Disorder or Type of Therapy

Exploring a psychological disorder or a specific treatment modality can also be a good topic for a psychology paper. Some potential abnormal psychology topics include specific psychological disorders or particular treatment modalities, including:

• Eating disorders
• Borderline personality disorder
• Seasonal affective disorder
• Schizophrenia
• Antisocial personality disorder
• Profile a  type of therapy  (i.e., cognitive-behavioral therapy, group therapy, psychoanalytic therapy)

Topics of Psychology Research Related to Human Cognition

Some of the possible topics you might explore in this area include thinking, language, intelligence, and decision-making. Other ideas might include:

• False memories
• Speech disorders
• Problem-solving

Topics of Psychology Research Related to Human Development

In this area, you might opt to focus on issues pertinent to  early childhood  such as language development, social learning, or childhood attachment or you might instead opt to concentrate on issues that affect older adults such as dementia or Alzheimer's disease.

Some other topics you might consider include:

• Language acquisition
• Media violence and children
• Learning disabilities
• Gender roles
• Child abuse
• Prenatal development
• Parenting styles
• Aspects of the aging process

Do a Critique of Publications Involving Psychology Research Topics

One option is to consider writing a critique paper of a published psychology book or academic journal article. For example, you might write a critical analysis of Sigmund Freud's Interpretation of Dreams or you might evaluate a more recent book such as Philip Zimbardo's  The Lucifer Effect: Understanding How Good People Turn Evil .

Professional and academic journals are also great places to find materials for a critique paper. Browse through the collection at your university library to find titles devoted to the subject that you are most interested in, then look through recent articles until you find one that grabs your attention.

Topics of Psychology Research Related to Famous Experiments

There have been many fascinating and groundbreaking experiments throughout the history of psychology, providing ample material for students looking for an interesting term paper topic. In your paper, you might choose to summarize the experiment, analyze the ethics of the research, or evaluate the implications of the study. Possible experiments that you might consider include:

• The Milgram Obedience Experiment
• The Stanford Prison Experiment
• The Little Albert Experiment
• Pavlov's Conditioning Experiments
• The Asch Conformity Experiment
• Harlow's Rhesus Monkey Experiments

Topics of Psychology Research About Historical Figures

One of the simplest ways to find a great topic is to choose an interesting person in the  history of psychology  and write a paper about them. Your paper might focus on many different elements of the individual's life, such as their biography, professional history, theories, or influence on psychology.

While this type of paper may be historical in nature, there is no need for this assignment to be dry or boring. Psychology is full of fascinating figures rife with intriguing stories and anecdotes. Consider such famous individuals as Sigmund Freud, B.F. Skinner, Harry Harlow, or one of the many other  eminent psychologists .

Psychology Research Topics About a Specific Career

​Another possible topic, depending on the course in which you are enrolled, is to write about specific career paths within the  field of psychology . This type of paper is especially appropriate if you are exploring different subtopics or considering which area interests you the most.

In your paper, you might opt to explore the typical duties of a psychologist, how much people working in these fields typically earn, and the different employment options that are available.

Topics of Psychology Research Involving Case Studies

One potentially interesting idea is to write a  psychology case study  of a particular individual or group of people. In this type of paper, you will provide an in-depth analysis of your subject, including a thorough biography.

Generally, you will also assess the person, often using a major psychological theory such as  Piaget's stages of cognitive development  or  Erikson's eight-stage theory of human development . It is also important to note that your paper doesn't necessarily have to be about someone you know personally.

In fact, many professors encourage students to write case studies on historical figures or fictional characters from books, television programs, or films.

Psychology Research Topics Involving Literature Reviews

Another possibility that would work well for a number of psychology courses is to do a literature review of a specific topic within psychology. A literature review involves finding a variety of sources on a particular subject, then summarizing and reporting on what these sources have to say about the topic.

Literature reviews are generally found in the  introduction  of journal articles and other  psychology papers , but this type of analysis also works well for a full-scale psychology term paper.

Topics of Psychology Research Based on Your Own Study or Experiment

Many psychology courses require students to design an actual psychological study or perform some type of experiment. In some cases, students simply devise the study and then imagine the possible results that might occur. In other situations, you may actually have the opportunity to collect data, analyze your findings, and write up your results.

Finding a topic for your study can be difficult, but there are plenty of great ways to come up with intriguing ideas. Start by considering your own interests as well as subjects you have studied in the past.

Online sources, newspaper articles, books , journal articles, and even your own class textbook are all great places to start searching for topics for your experiments and psychology term papers. Before you begin, learn more about  how to conduct a psychology experiment .

What This Means For You

After looking at this brief list of possible topics for psychology papers, it is easy to see that psychology is a very broad and diverse subject. While this variety makes it possible to find a topic that really catches your interest, it can sometimes make it very difficult for some students to select a good topic.

If you are still stumped by your assignment, ask your instructor for suggestions and consider a few from this list for inspiration.

• Hockenbury, SE & Nolan, SA. Psychology. New York: Worth Publishers; 2014.
• Santrock, JW. A Topical Approach to Lifespan Development. New York: McGraw-Hill Education; 2016.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

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What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy. 

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes. 

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition. 

Screening Research aims to find the best ways to detect certain disorders or health conditions. 

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness. 

Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up. 

Epidemiological studies seek to identify the patterns, causes, and control of disorders in groups of people. 

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some is “inpatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires. 

Phases of clinical trials: when clinical research is used to evaluate medications and devices Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions. 

Phase I trials Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects. 

Phase II trials The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III trials The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. 

Phase IV trials Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research Many people believe that all clinical research involves testing of new medications or devices. This is not true, however. Some studies do not involve testing medications and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to results of people with the illness being studied. Some examples of other kinds of research include the following: 

A long-term study that involves psychological tests or brain scans

A genetic study that involves blood tests but no changes in medication

A study of family history that involves talking to family members to learn about people’s medical needs and history.

Best Nursing Research Topics for Students

What is a nursing research paper.

• What They Include
• Choosing a Topic
• Best Nursing Research Topics
• Research Paper Writing Tips

Writing a research paper is a massive task that involves careful organization, critical analysis, and a lot of time. Some nursing students are natural writers, while others struggle to select a nursing research topic, let alone write about it.

If you're a nursing student who dreads writing research papers, this article may help ease your anxiety. We'll cover everything you need to know about writing nursing school research papers and the top topics for nursing research.  

Continue reading to make your paper-writing jitters a thing of the past.

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A nursing research paper is a work of academic writing composed by a nurse or nursing student. The paper may present information on a specific topic or answer a question.

During LPN/LVN and RN programs, most papers you write focus on learning to use research databases, evaluate appropriate resources, and format your writing with APA style. You'll then synthesize your research information to answer a question or analyze a topic.

BSN , MSN , Ph.D., and DNP programs also write nursing research papers. Students in these programs may also participate in conducting original research studies.

Writing papers during your academic program improves and develops many skills, including the ability to:

• Select nursing topics for research
• Conduct effective research
• Analyze published academic literature
• Format and cite sources
• Synthesize data
• Organize and articulate findings

About Nursing Research Papers

When do nursing students write research papers.

You may need to write a research paper for any of the nursing courses you take. Research papers help develop critical thinking and communication skills. They allow you to learn how to conduct research and critically review publications.

That said, not every class will require in-depth, 10-20-page papers. The more advanced your degree path, the more you can expect to write and conduct research. If you're in an associate or bachelor's program, you'll probably write a few papers each semester or term.

Do Nursing Students Conduct Original Research?

Most of the time, you won't be designing, conducting, and evaluating new research. Instead, your projects will focus on learning the research process and the scientific method. You'll achieve these objectives by evaluating existing nursing literature and sources and defending a thesis.

However, many nursing faculty members do conduct original research. So, you may get opportunities to participate in, and publish, research articles.

Example Research Project Scenario:

In your maternal child nursing class, the professor assigns the class a research paper regarding developmentally appropriate nursing interventions for the pediatric population. While that may sound specific, you have almost endless opportunities to narrow down the focus of your writing. 

You could choose pain intervention measures in toddlers. Conversely, you can research the effects of prolonged hospitalization on adolescents' social-emotional development.

What Does a Nursing Research Paper Include?

Your professor should provide a thorough guideline of the scope of the paper. In general, an undergraduate nursing research paper will consist of:

Introduction : A brief overview of the research question/thesis statement your paper will discuss. You can include why the topic is relevant.

Body : This section presents your research findings and allows you to synthesize the information and data you collected. You'll have a chance to articulate your evaluation and answer your research question. The length of this section depends on your assignment.

Conclusion : A brief review of the information and analysis you presented throughout the body of the paper. This section is a recap of your paper and another chance to reassert your thesis.

The best advice is to follow your instructor's rubric and guidelines. Remember to ask for help whenever needed, and avoid overcomplicating the assignment!

How to Choose a Nursing Research Topic

The sheer volume of prospective nursing research topics can become overwhelming for students. Additionally, you may get the misconception that all the 'good' research ideas are exhausted. However, a personal approach may help you narrow down a research topic and find a unique angle.

Writing your research paper about a topic you value or connect with makes the task easier. Additionally, you should consider the material's breadth. Topics with plenty of existing literature will make developing a research question and thesis smoother.

Finally, feel free to shift gears if necessary, especially if you're still early in the research process. If you start down one path and have trouble finding published information, ask your professor if you can choose another topic.

The Best Research Topics for Nursing Students

You have endless subject choices for nursing research papers. This non-exhaustive list just scratches the surface of some of the best nursing research topics.

1. Clinical Nursing Research Topics

• Analyze the use of telehealth/virtual nursing to reduce inpatient nurse duties.
• Discuss the impact of evidence-based respiratory interventions on patient outcomes in critical care settings.
• Explore the effectiveness of pain management protocols in pediatric patients.

2. Community Health Nursing Research Topics

• Assess the impact of nurse-led diabetes education in Type II Diabetics.
• Analyze the relationship between socioeconomic status and access to healthcare services.

3. Nurse Education Research Topics

• Review the effectiveness of simulation-based learning to improve nursing students' clinical skills.
• Identify methods that best prepare pre-licensure students for clinical practice.
• Investigate factors that influence nurses to pursue advanced degrees.
• Evaluate education methods that enhance cultural competence among nurses.
• Describe the role of mindfulness interventions in reducing stress and burnout among nurses.

4. Mental Health Nursing Research Topics

• Explore patient outcomes related to nurse staffing levels in acute behavioral health settings.
• Assess the effectiveness of mental health education among emergency room nurses .
• Explore de-escalation techniques that result in improved patient outcomes.
• Review the effectiveness of therapeutic communication in improving patient outcomes.

5. Pediatric Nursing Research Topics

• Assess the impact of parental involvement in pediatric asthma treatment adherence.
• Explore challenges related to chronic illness management in pediatric patients.
• Review the role of play therapy and other therapeutic interventions that alleviate anxiety among hospitalized children.

6. The Nursing Profession Research Topics

• Analyze the effects of short staffing on nurse burnout .
• Evaluate factors that facilitate resiliency among nursing professionals.
• Examine predictors of nurse dissatisfaction and burnout.
• Posit how nursing theories influence modern nursing practice.

Tips for Writing a Nursing Research Paper

The best nursing research advice we can provide is to follow your professor's rubric and instructions. However, here are a few study tips for nursing students to make paper writing less painful:

Avoid procrastination: Everyone says it, but few follow this advice. You can significantly lower your stress levels if you avoid procrastinating and start working on your project immediately.

Plan Ahead: Break down the writing process into smaller sections, especially if it seems overwhelming. Give yourself time for each step in the process.

Research: Use your resources and ask for help from the librarian or instructor. The rest should come together quickly once you find high-quality studies to analyze.

Outline: Create an outline to help you organize your thoughts. Then, you can plug in information throughout the research process. 

Clear Language: Use plain language as much as possible to get your point across. Jargon is inevitable when writing academic nursing papers, but keep it to a minimum.

Cite Properly: Accurately cite all sources using the appropriate citation style. Nursing research papers will almost always implement APA style. Check out the resources below for some excellent reference management options.

Revise and Edit: Once you finish your first draft, put it away for one to two hours or, preferably, a whole day. Once you've placed some space between you and your paper, read through and edit for clarity, coherence, and grammatical errors. Reading your essay out loud is an excellent way to check for the 'flow' of the paper.

Helpful Nursing Research Writing Resources:

Purdue OWL (Online writing lab) has a robust APA guide covering everything you need about APA style and rules.

Grammarly helps you edit grammar, spelling, and punctuation. Upgrading to a paid plan will get you plagiarism detection, formatting, and engagement suggestions. This tool is excellent to help you simplify complicated sentences.

Mendeley is a free reference management software. It stores, organizes, and cites references. It has a Microsoft plug-in that inserts and correctly formats APA citations.

Don't let nursing research papers scare you away from starting nursing school or furthering your education. Their purpose is to develop skills you'll need to be an effective nurse: critical thinking, communication, and the ability to review published information critically.

Choose a great topic and follow your teacher's instructions; you'll finish that paper in no time.

Joleen Sams is a certified Family Nurse Practitioner based in the Kansas City metro area. During her 10-year RN career, Joleen worked in NICU, inpatient pediatrics, and regulatory compliance. Since graduating with her MSN-FNP in 2019, she has worked in urgent care and nursing administration. Connect with Joleen on LinkedIn or see more of her writing on her website.

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Article Contents

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Key Topics in Clinical Research

• Article contents
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• Supplementary Data

F. Carli, P. Ruiz, Key Topics in Clinical Research , BJA: British Journal of Anaesthesia , Volume 91, Issue 1, July 2003, Page 163, https://doi.org/10.1093/bja/aeg588

Key Topics in Clinical Research. 
 F. G. Smith and J. E. Smith (editors).
 Published by BIOS Scientific Publishers Ltd, Oxford.
 Pp. 206; indexed; illustrated. ISBN 1‐85996‐028‐6.

As described in the preface, this book is based on the tutorials and courses given by the authors, who are clinicians and researchers based in teaching hospitals. The content of the book, Clinical Research, embraces a large number of subjects ranging from how to design a research project to statistical analysis and grant applications. Most of this literature is provided in other textbooks. For researchers without previous experience, however, reading those textbooks might be difficult or time‐consuming, adding an additional hurdle to the research process.

The aim of the book is to consolidate the fundamentals of clinical research in a straightforward way, with short chapters. At the end of each chapter, there is a list of further reading and related topics of interest.

The book has a logical sequence; it starts with the importance of medical research during postgraduate training and after specialist training. Then the research process is dissected, from the initial research idea and review of the literature to the design of the research. The different types of clinical trials and their advantages and disadvantages are described.

The authors analyze the basic topics concerning research involving animals, from its importance, to regulatory and ethical issues. Although the regulatory Animal Act described in the book only applies to the UK, it reminds the reader of the legal and ethical aspects associated with animal experimentation. The book describes the basic steps on estimating sample size and power, which can be helpful for the initial discussion the researcher will have with the statistician. The book also provides hints and tips on how to address research ethical committees and how to organize a grant application. Reasons for failure in both situations are commented upon, and corrections suggested.

Approximately 100 pages of the book are devoted to data collection and measurement, data organization, and statistical analysis. Although not intending to be a book on medical statistics, we found the discussion on measurements of central tendency and dispersion and the principles of hypothesis testing very helpful. This is followed by the statistical tests most used in clinical research, with examples and explanatory figures and tables. Towards the end of the book, after discussing how to design a study and collect, organize and analyze data, a chapter by the book’s editors, described in their own words as a ‘cookbook’, summarizes how to choose the most appropriate statistical method.

Basic concepts are given on how to prepare an oral presentation and submit a paper to a journal. Issues such as how to choose the journal to submit the paper to, and technicalities of the submission process are discussed. A brief discussion on the preparation of a thesis or dissertation is also included in the final part of the chapter. The following chapter is also related to those two topics and discusses how to prepare and quote references of a paper or thesis. The process of peer review is described, and some advice is given on how to answer criticism from an editor and referees. The basic concepts of the audit process as part of quality assessment and assurance programmes, and a brief discussion on protocols and guidelines are found in the closing pages of this handbook.

There is just one minor typographical error in Table 1 of the chapter entitled ‘Sample Size and Power’. Overall, we found the book easy to read, especially considering the amount of statistical concepts present in it. We would recommend this book as a helpful quick reference either for those already involved with or for those intending to initiate clinical research.

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Clinical Research Trials and You: Questions and Answers

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What is a clinical trial?

A clinical trial is a research study that involves people like you. Researchers conduct clinical trials to find new or better ways to prevent, detect, or treat health conditions. Often, researchers want to find out if a new test, treatment, or preventive measure is safe and effective. Tests can include ways to screen for, diagnose, or prevent a disease or condition. Treatments and preventive measures can include medications, surgeries, medical devices, and behavioral therapies.

Clinical trials are important because they serve as the foundation for most medical advances. Without clinical trials, many of the medical treatments and cures we have today wouldn’t exist.

Why should I volunteer for a clinical trial?

People volunteer for clinical trials for many reasons. Some want to advance science or help doctors and researchers learn more about disease and improve health care. Others, such as those with an illness, may join to try new or advanced treatments that aren’t widely available.

Whatever your reason for joining a clinical trial, researchers generally need two types of volunteers: those without specific illnesses or conditions and those with them.  

A healthy volunteer is someone in a clinical trial with no known related health problems. Researchers need healthy volunteers to establish a healthy or optimal reference point. They use data from healthy volunteers to test new treatments or interventions, not to provide direct benefit to participants.

A patient volunteer is someone in a clinical trial who has the condition being studied. Researchers need patient volunteers to learn if new tests, treatments, or preventive measures are safe and effective. Not all trial participants will receive experimental medications or treatments; sometimes, participants may receive a placebo. Researchers need to vary medications and treatments so they can compare results and learn from their differences.

While a study’s treatment or findings may help patients directly, sometimes participants will receive no direct benefit. However, in many cases, study results can still serve as building blocks that are used to help people later.

What would I experience during a clinical trial?

During a clinical trial, the study team will track your health. Participating in a clinical trial may take more time than standard treatment, and you may have more tests and treatments than you would if you weren’t in a clinical trial. The study team also may ask you to keep a log of symptoms or other health measures, fill out forms about how you feel, or complete other tasks. You may need to travel or reside away from home to take part in a study.

What are the risks and benefits of my participation in a clinical trial?

Clinical trials can provide many benefits to participants and society. However, before volunteering for a clinical trial, you should talk with your health care provider and the study team about the risks and benefits.

Potential Risks

When weighing the risks of volunteering, you should consider:

• The likelihood of any harm occurring
• How much harm could result from your participation in the study

Researchers try to limit patient discomfort during clinical trials. However, in some cases, volunteers have complications that require medical attention. In rare cases, volunteers have died when participating in clinical trials.

Potential Benefits

The benefits of volunteering can include:

• Treatment with study medications that may not be available elsewhere
• Care from health care professionals who are familiar with the most advanced treatments available
• The opportunity to learn more about an illness and how to manage it
• Playing an active role in your health care
• Helping others by contributing to medical research

Where can I find a mental health clinical trial?

The National Institute of Mental Health (NIMH) is the lead federal agency for research on mental disorders. While NIMH supports research around the world, it also conducts many clinical trials at the National Institutes of Health (NIH) campus in Bethesda, Maryland.

To learn more about NIMH studies conducted on the NIH campus, visit  NIMH's Join a Study webpage . These studies enroll volunteers from the local area and across the nation. In some cases, participants receive free study-related evaluations, treatment, and transportation to NIH.

To learn more about NIMH-funded clinical trials at universities, medical centers, and other institutions, visit  NIMH's clinical trials webpage .

What is the next step after I find a clinical trial?

To learn more about a specific clinical trial, contact the study coordinator. You can usually find this contact information in the trial’s description.

If you decide to join a clinical trial, let your health care provider know. They may want to talk to the study team to coordinate your care and ensure the trial is safe for you. Find tips to help prepare for and get the most out of your visit .

How do I know if I can join a clinical trial?

People of all ages, ethnicities, and racial backgrounds can volunteer for clinical trials. If you want to join a clinical trial, you must be eligible to participate in that specific trial. Your eligibility can usually be determined by phone or online screening.

All clinical trials have eligibility guidelines called inclusion and exclusion criteria. These criteria may include:

• The type and stage of an illness
• Treatment history
• Other medical conditions

Researchers use these guidelines to find suitable study participants, maximize participant safety, and ensure trial data are accurate.

What kinds of questions should I ask the study team before deciding if I want to take part in a clinical trial?

It can be helpful to write down any questions or concerns you have. When you speak with the study team, you may want to take notes or ask to record the conversation. Bringing a supportive friend or family member may also be helpful.

The following topics may give you some ideas for questions to ask:

• The study’s purpose and duration
• The possible risks and benefits
• Your participation and care
• Personal and cost concerns

For a list of specific questions, check out Questions to Ask About Volunteering for a Research Study  from the U.S. Department of Health and Human Services’ Office for Human Research Protections.

How is my safety protected if I choose to take part in a clinical trial?

Strict rules and laws help protect participants in research studies, and the study team must follow these rules to conduct research. Below are some measures that can help ensure your safety.  

Ethical Guidelines

Ethical guidelines protect volunteers and ensure a study’s scientific integrity. Regulators created these guidelines primarily in response to past research errors and misconduct. Federal policies and regulations require that researchers conducting clinical trials obey these ethical guidelines.

Informed Consent

Before joining a trial, you should understand what your participation will involve. The study team will provide an informed consent document with detailed information about the study. The document will include details about the length of the trial, required visits, medications, and medical procedures. It will also explain the expected outcomes, potential benefits, possible risks, and other trial details. The study team will review the informed consent document with you and answer any questions you have. You can decide then or later if you want to take part in the trial.

If you choose to join the trial, you will be asked to sign the informed consent document. This document is not a contract; it verifies you understand the study and describes what your participation will include and how your data will be used. Your consent in a clinical trial is ongoing and your participation is voluntary. You may stop participating at any time.

Institutional Review Board Review

Institutional review boards (IRBs) review and monitor most clinical trials in the United States. An IRB works to protect the rights, welfare, and privacy of human subjects. An IRB usually includes a team of independent doctors, scientists, and community members. The IRB’s job is to review potential studies, weigh the risks and benefits of studies, and ensure that studies are safe and ethical.

If you’re thinking about volunteering for a clinical trial, ask if an IRB reviewed the trial.

What happens when a clinical trial ends?

When a clinical trial ends, researchers will analyze the data to help them determine the results. After reviewing the findings, researchers often submit them to scientific journals for others to review and build on.

Before your participation ends, the study team should tell you if and how you’ll receive the results. If this process is unclear, be sure to ask about it.

Where can I find more information?

This fact sheet covers the basics of clinical trials. To find more details and resources, visit  NIMH's clinical trials webpage .

For More Information

MedlinePlus  (National Library of Medicine) ( en español  )

ClinicalTrials.gov  ( en español  )

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health NIH Publication No. 23-MH-4379 Revised 2023

The information in this publication is in the public domain and may be reused or copied without permission. However, you may not reuse or copy images. Please cite the National Institute of Mental Health as the source. Read our copyright policy to learn more about our guidelines for reusing NIMH content.

Topics in Clinical Nutrition

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July/September 2024 - Volume 39 - Issue 3

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Topics in Clinical Nutrition. 39(3):183, July/September 2024.

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Contribution to the Validation of the Portuguese Version of the “Barriers to Enterally Feeding Critically Ill Patients” Questionnaire and Its Application in a Hospital Context

Topics in Clinical Nutrition. 39(3):184-197, July/September 2024.

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The Value of Metabolites and Vitamins for the Assessment of Nutritional Status in Hospitalized Patients: A Systematic Review

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Topics in Clinical Nutrition. 39(3):259-273, July/September 2024.

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Clinical trial assesses the efficacy of suvorexant in reducing delirium in older adults

by Juntendo University Research Promotion Center

Delirium is a sudden onset and temporary state of disturbed consciousness or cognition, occurring due to underlying medical issues like fever or alcohol withdrawal. It is most common among older hospitalized adults aged 75 years or above, leading to increased risk of falls, dementia, low life expectancy, and high health care expenses.

Non-pharmacological approaches to prevent or reduce delirium are time-consuming, hard to implement, and partially effective. So, pharmacological interventions offer hope. Insomnia, a significant risk factor for delirium, could be alleviated with sleep-promoting medications.

However, not all medications are suitable. Some may aggravate delirium. Interestingly, suvorexant (an orexin receptor antagonist) promotes sleep by blocking a neuropeptide called orexin that regulates wakefulness. This mechanism could prevent delirium, as shown by many studies.

Against this backdrop, a team of researchers involving Professor Kotaro Hatta from the Department of Psychiatry at Juntendo University Nerima Hospital in Tokyo, Japan, tested whether suvorexant can reduce delirium in older adults at high risk for delirium after hospitalization.

Their study was published in JAMA Network Open on August 16, 2024.

Reflecting on the motivation behind the study, Prof. Hatta says, "While working as a psychiatric liaison at a general hospital, I was busy managing patients with delirium every day. So, when an orexin receptor antagonist became available, we decided to use this drug to target the sleep-wake cycle disturbances, a primary clinical manifestation of delirium."

To this end, researchers conducted a double-blind, placebo-controlled, phase 3 randomized clinical trial across 50 Japanese hospitals from October 2020 to December 2022. The trial included 203 Japanese adults aged 65 to 90 years who were at high risk for delirium and hospitalized for sudden illness or scheduled surgery.

Participants were randomly assigned to two groups, with 101 receiving suvorexant (15 mg) and 102 receiving a placebo each night for five to seven days. They were assessed daily for delirium based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria.

Subtypes of delirium—namely hyperactive (marked by agitation, hallucination, and impulsivity), hypoactive (marked by drowsiness and apathy), and mixed (shifts between hyperactive and hypoactive delirium)—were also recorded for those who exhibited delirium. Researchers then compared both groups to assess whether suvorexant made a difference.

Consistent with expectations, suvorexant showed a trend toward reducing delirium, with only 16.8% of participants exhibiting delirium compared to 26.5% in the placebo group. However, the difference was not statistically significant. Both groups also experienced similar adverse events, such as constipation and vomiting.

The incidence of hypoactive delirium was similar between the suvorexant (5.9%) and placebo groups (4.9%). However, in the post-hoc exploratory analysis, the incidence of hyperactive and mixed delirium was lower in the suvorexant group (10.9%) compared to placebo (21.6%). Delirium with a hyperactive component was considered since it interferes with surgery or treatment, making it burdensome for hospital staff.

As the results suggest, suvorexant may not have preventive effects on hypoactive delirium but could benefit hyperactive and mixed delirium.

Explaining the results, Prof. Hatta emphasizes, "The lack of significant reduction of delirium after taking suvorexant was surprising since previous studies reported positive findings. However, these studies did not distinguish between delirium subtypes except for one study that excluded hypoactive delirium due to its irrelevance in postoperative management and another that defined the primary outcome as delirium of any type. So, we believe that previous studies have focused more on hyperactive or mixed delirium and overlooked hypoactive delirium ."

Prof. Hatta says, "Addressing this issue can increase the life expectancy of older adults and reduce the burden on health care providers."

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