Whole Person Health Patient-Reported Outcome Measures in Psychedelic Mental Health Trials: A Systematic Review of Current Practices

Abstract

This project is a qualitative systematic review of patient-reported outcome measurement practices in psychedelic clinical research for mental health populations. Psychedelic therapy has reemerged as a promising intervention for conditions including treatment-resistant depression, anxiety disorders, post-traumatic stress disorder (PTSD), and even substance use disorders. As research in this field expands, most trials have prioritized generating replicable safety and efficacy data.⁷ However, alongside the prevailing processes toward regulatory approval, growing evidence indicates that the therapeutic effects of psychedelics extend beyond symptom reduction, encompassing improvements in emotional openness, self-acceptance, spiritual connection, and existential meaning.¹⁻⁶ Despite this broader experiential range, conventional symptom-based instruments remain the predominant outcome measures in clinical trials.⁷ This narrow measurement approach risks overlooking functional, psychosocial, and spiritual dimensions of healing that patients frequently describe as central to recovery. At the same time, a broader transformation is underway across healthcare, with major institutions converging on definitions of whole-person health that move decisively beyond disease-based models. For example, the U.S. Department of Veterans Affairs (VA) has adopted a Whole Health framework that explicitly positions mental health as integral to overall well-being, recognizing that emotional and behavioral functioning are inseparable from physical, social, and spiritual health.⁸ The National Academies of Sciences, Engineering, and Medicine (NASEM) has further articulated whole-person health as the interconnectedness of “physical, behavioral, spiritual, and socioeconomic domains as defined by individuals, families, and communities” that collectively determine outcomes.⁸ Similarly, the National Center for Complementary and Integrative Health (NCCIH) defines whole-person health as “the health and well-being of each person across multiple domains—biological, behavioral, social, and environmental.”⁹ These frameworks not only redefine how mental health is conceptualized but also highlight the role of validated patient-reported outcome measures (PROMs) in assessing multidimensional well-being.¹⁰ In 2025, the NCCIH further advanced this shift by introducing the Whole Person Health Index (WPHI), a PROM specifically designed to capture essential biological, behavioral, social, and other salient components of health.¹¹ The development of the WPHI underscores the central role of PROMs in operationalizing whole-person health across clinical care, public health, and research. Together, these institutional efforts signal a momentous shift in health research and care delivery: well-being is no longer being reduced to symptom remission but is increasingly framed in terms of multidimensional outcomes that reflect resilience, meaning, purpose, and social connection in the context of patients and their communities. The VA’s nationwide rollout of the Whole Health model by 2027 underscores the urgency of aligning outcome measurement in psychedelic studies with this broader transformation. This review addresses a critical gap by systematically evaluating the extent to which whole-person health outcomes are defined, measured, and reported in psychedelic clinical studies—if at all. The objectives are to (1) determine the proportion of studies that employ PROMs consistent with whole-person health, and (2) characterize the domains and instruments used. A framework synthesis approach will be applied, anchored to both the Veterans Health Administration’s Whole Health model and a predefined operational definition requiring measurement of biological/physical and behavioral/mental domains plus at least one additional domain (social, environmental, spiritual, or other individual). Expected outcomes include a descriptive synthesis of current practices, identification of underrepresented domains, and guidance for aligning future psychedelic trial designs with emerging standards in whole-person, patient-centered mental health care. In doing so, this review supports the integration of psychedelic science with evolving health system frameworks. References 1. Neuhaus EC, Slavich GM. Behavioral Psychedelics: Integrating Mind and Behavior to Improve Health and Resilience. Front Psychiatry. 2022;13:821208. doi:10.3389/fpsyt.2022.821208 2. Watts R, Kettner H, Geerts D, et al. The Watts Connectedness Scale: a new scale for measuring a sense of connectedness to self, others, and world. Psychopharmacology (Berl). 2022;239(11):3461-3483. doi:10.1007/s00213-022-06187-5 3. Weiss B, Nygart V, Pommerencke LM, Carhart-Harris RL, Erritzoe D. Examining Psychedelic-Induced Changes in Social Functioning and Connectedness in a Naturalistic Online Sample Using the Five-Factor Model of Personality. Front Psychol. 2021;12:749788. doi:10.3389/fpsyg.2021.749788 4. Mans K, Kettner H, Erritzoe D, Haijen ECHM, Kaelen M, Carhart-Harris RL. Sustained, Multifaceted Improvements in Mental Well-Being Following Psychedelic Experiences in a Prospective Opportunity Sample. Front Psychiatry. 2021;12:647909. doi:10.3389/fpsyt.2021.647909 5. Rupiński P, Drabek W, Holas P. A systematic review of psychedelic use and its relationship with meaning and purpose in life. J Psychedelic Stud. Published online April 25, 2025. doi:10.1556/2054.2025.00442 6. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025-1033. doi:10.1038/s41591-021-01336-3 7. Kishon R, Modlin NL, Cycowicz YM, et al. A rapid narrative review of the clinical evolution of psychedelic treatment in clinical trials. Npj Ment Health Res. 2024;3(1):33. doi:10.1038/s44184-024-00068-9 8. Committee on Transforming Health Care to Create Whole Health: Strategies to Assess, Scale, and Spread the Whole Person Approach to Health, Board on Health Care Services, Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine. Achieving Whole Health: A New Approach for Veterans and the Nation. (Krist AH, South-Paul J, Meisnere M, eds.). National Academies Press; 2023:26854. doi:10.17226/26854 9. Langevin HM. Moving the complementary and integrative health research toward whole person health. J AlternComplement Med 2021;27(8):623–626; doi: 10.1089/acm.2021.0255 10. Nicosia FM, Purcell N, Bertenthal D, et al. Evaluation of a New Integrative Health and Wellness Clinic for Veterans at the San Francisco VA Health Care System: A Mixed-Methods Pilot Study. Glob Adv Integr Med Health. 2024;13:27536130241260034. doi:10.1177/27536130241260034 11. Langevin HM. The Whole Person Health Index: An Integrated Self-Reported Measure Capturing Essential Components of Health. National Center for Complementary and Integrative Health. Published February 19, 2025. Accessed September 8, 2025. https://www.nccih.nih.gov/research/blog/the-whole-person-health-index-an-integrated-self-reported-measure-capturing-essential-components-of-health

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