Psychological support in psychedelic-assisted therapy clinical trials: A systematic review.
Bonnie Brusky, Katia M'Bailara, François Alla, Marion Barrault
Journal of Psychopharmacology May 1, 2026 DOI: 10.1177/02698811261424204 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Peer reviewed |
|---|---|
| Sample size | 449 |
| Population | Patients in clinical trials of psilocybin, MDMA, or lysergic acid diethylamide with psychological support |
| Topics | Psychedelic-assisted therapy |
| Keywords | Common factors Complex interventions Psychotherapy |
| Key findings | Psychological interventions in most therapeutic psychedelic trials qualify as psychotherapy based on a common factors framework. |
Abstract
The nature and role of the psychological support provided in psychedelic-assisted treatments for psychiatric disorders are currently the object of debate. How this support is conceptualized-as a vector for therapeutic change or framework for risk minimization-has far-reaching consequences in terms of how these treatments should be regulated, delivered, and studied. To determine whether psychological interventions in psychedelic trials meet accepted definitions of psychotherapy using a common factors framework. We assess whether self-described psychedelic-assisted psychotherapies align with psychotherapy criteria and whether trials where support is not defined as psychotherapy nonetheless embed psychotherapeutic elements. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched PubMed and PsycINFO in January 2024 for all available clinical trials of psilocybin, MDMA, or lysergic acid diethylamide reporting any psychological support. Articles were assessed against a 4-item common factors framework. We screened 224 records, reviewed 52 full-text documents, and included 29 clinical trials (449 patients). Of the 29 trials, 69% met all 4 factors. Of the 19 psychotherapy-labeled trials, 84% met all 4 factors. Of the 10 non-psychotherapy-labeled studies, 40% met 4 factors. Findings indicate that the psychological interventions in most therapeutic psychedelic trials qualify as psychotherapy. We highlight the clinical implications in terms of clinician training and treatment timeframe. We emphasize the ethical imperative to measure and address the intervention complexity inherent to psychedelic trials, to optimize clinical outcomes and safeguard patients.
Comparable studies
Other systematic reviews and meta-analyses on psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| A Meta-Analysis of Placebo-Controlled Trials of Psychedelic-Assisted Therapy | 2020 | Systematic review | |
| Psychedelic-Assisted Psychotherapy—A Systematic Review of Associated Psychological Interventions | 2022 | Systematic review | |
| Psychedelic therapy for depressive symptoms: A systematic review and meta-analysis. Participants in studies of psychedelic therapy for depressive symptoms (Major... | 2023 | Systematic review with meta-analysis | n = 14 |
| Psilocybin-assisted therapy for depression: A systematic review and meta-analysis. Patients diagnosed with life-threatening illnesses or major depressive disorder | 2023 | Systematic review and meta-analysis | n = 686 |
| Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy Patients with PTSD | 2016 | Meta-analysis |
Citations in the library
Cites 100
- 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
- Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Psychopharmacology July 7, 2006
- Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
and 95 more in the library