A systematic review of participant diversity in psychedelic-assisted psychotherapy trials.
Stephanie L. Haft, Amanda E. Downey, Marissa Raymond-Flesch, Gisele Fernandes-Osterhold, Ellen Bradley, Aoife O'Donovan, Joshua Woolley
Psychiatry Research March 1, 2025 DOI: 10.1016/j.psychres.2025.116359 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Randomized Peer reviewed |
|---|---|
| Sample size | 1,034 |
| Population | Participants in randomized controlled trials of psilocybin- and MDMA-assisted therapies |
| Topics | MDMA Psilocybin Psychedelic-assisted therapy |
| Keywords | Psychedelic research MDMA Therapy Systematic review Clinical diversity Psilocybin trials Participant demographics |
| Citations | 22 |
| Key findings | Black/African-American and Hispanic/Latino participants were significantly underrepresented in psychedelic-assisted psychotherapy trials compared to their representation in the US population and non-psychedelic clinical trials. |
Abstract
A lack of diverse and representative participant samples in mental health intervention research perpetuates mental health disparities. This issue has become a salient concern in studies of psychedelic-assisted psychotherapy (PAT), which is emerging as a promising mental health intervention. This systematic review evaluates the reporting, representation, and analysis of participant sociodemographic characteristics in randomized controlled trials (RCTs) of PAT. A total of 21 RCTs of psilocybin- and 3,4-methylenedioxy methamphetamine (MDMA)-assisted therapies (N = 1034) are summarized. Participants' gender (100%) and race or ethnicity (76%) were frequently reported, with socioeconomic status (SES) sometimes (57%) reported using heterogeneous metrics. Sexual orientation (9.5%) and immigration status (4.8%) were rarely reported, and no studies reported gender identity. Compared to their representation in the US population and non-psychedelic clinical trials, Black/African-American participants (2.2%) and Hispanic/Latino participants (7.2%) were significantly underrepresented in PAT RCTs. MDMA trials enrolled more diverse participant samples than psilocybin trials. Analyses on treatment effects based on demographic variables were virtually nonexistent. These findings underscore the need for more inclusive recruitment strategies, along with more rigorous reporting, to improve the generalizability of PAT research.
Comparable studies
Other systematic reviews and meta-analyses on MDMA and psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 24
- Psychedelic Therapy vs Antidepressants for the Treatment of Depression Under Equal Unblinding Conditions JAMA Psychiatry March 18, 2026
- Unequal representation? A cross-sectional analysis of age, sex, race, and ethnicity in clinical trials of classic psychedelics Journal of Psychopharmacology July 11, 2025
- Low-income group psilocybin assisted therapy for depression: An Oregon feasibility study Journal of Psychedelic Studies February 12, 2026
- Substance use predictors of arrest and self-reported criminal behavior in the United States: The role of psychedelics and rarely used drugs Journal of Psychopharmacology April 16, 2026
- Toward Greater Diversity in Psychedelic Science. Psychiatric Services February 5, 2026
and 19 more in the library
Cites 37
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Journal of Psychopharmacology November 30, 2016
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Archives of General Psychiatry September 7, 2010
and 32 more in the library