A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions
This systematic review of 33 psychedelic clinical trials found pervasive underreporting of psychosocial intervention details — for example, 33% omitted number of sessions, 45% omitted session duration, 42% omitted provider credentials, 52% did not report use of a therapy manual, 67% provided no accessible manual, and 82% did not assess treatment fidelity. Reporting was poorer than in non‑psychedelic trials, and the authors recommend standardised reporting of psychological support and fidelity measures to improve research transparency and treatment outcomes.
Abstract
Background
Psychedelic-assisted therapy has gained significant attention in recent years. However, there is a lack of empirical clarity on the role of psychosocial interventions (PI) in clinical trials of psychedelic treatment due in part to deficiencies in reporting practices found in the existing literature. These PI include non-drug support or interventions provided by psychotherapists or facilitators during all phases of treatment, sometimes called “psychological support,” “monitoring,” “psychedelic-assisted therapy,” or “psychedelic-assisted psychotherapy.” A brief review of recent research, historical studies, safety considerations, and participant perspectives suggest that PI has a substantive and critical impact on treatment outcomes.
Methods
This systematic review examines the reporting practices of PI in published clinical trial results. The review employs a search of PubMed/Medline and PSYCinfo databases to identify relevant articles. It includes quantitative clinical studies treating patients with psychiatric indications using classic psychedelics (psilocybin, LSD, DMT, ayahuasca) or empathogenic drugs (MDMA) since 2000. The analytic approach follows a modified version of assessment items based on CONSORT extension statement and TIDieR checklist.
Results
33 published psychedelic clinical trials met criteria. The review reveals that many published reports on psychedelic clinical trials did not report basic aspects of the intervention: 33% did not report the number of sessions, 45% did not report the duration of sessions, 42% did not report provider credentials, 52% did not report if their intervention used a therapy manual, 67% did not reference a manual that was available to readers, and 82% did not report that they assessed treatment fidelity. A comparison with non-psychedelic trials shows that psychedelic trial reports underreport on key items related to PI.
Discussion
The study highlights the problems of underreporting and the importance of improving reporting practices regarding PI in psychedelic clinical trials to enhance research standardization and improve treatment outcomes. Recommendations for improving reporting practices are provided.
Research Summary of 'A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions'
Introduction
Psychedelic-assisted therapies (PAT) combine a pharmacological agent (classic psychedelics or MDMA) with accompanying psychosocial interventions (PI). Prior empirical and historical sources suggest that relational and psychotherapeutic elements—therapeutic alliance, preparatory work, integration, and other forms of non-drug support—can shape subjective experiences and clinical outcomes. Evidence cited by the authors includes trial-derived analyses linking therapeutic alliance and emotional breakthrough to reductions in depressive symptoms, experimental comparisons of high- versus low-support adjuncts to psilocybin, observational studies of retreat participants that connect facilitator rapport to sustained well-being, and historical trials from the 1960s that suggest trials with more comprehensive psychosocial input yielded superior outcomes. Qualitative reports from trial participants further emphasise safety and rapport as central to perceived benefit, while safety literature raises concerns that inadequate PI may contribute to adverse events or harmful dynamics. B. and colleagues set out to evaluate how well PI are reported in contemporary PAT clinical trial publications. Their goal was practical: to assess whether trial reports provide enough detail to allow replicability in clinical practice and to permit assessment of generalisability. To do this they conducted a systematic review of quantitative clinical trials published in English since 2000 and assessed trial reports against a modified set of reporting items derived from established guidance (CONSORT/TIDieR) and prior work on multicomponent interventions. The review focused on reporting practices for non-drug psychosocial components rather than on trial efficacy per se.
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Study Details
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- APA Citation
Brennan, B., Kelman, A., & Belser, A. B. (2023). A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions. https://doi.org/10.31234/osf.io/2ab59
Cited By (3)
Papers in Blossom that reference this study
Stellmacher, J., Schmidt, C., Aicher, H. D. et al. · Frontiers in Psychiatry (2026)
Pronovost-Morgan, C., Greenway, K. T., Roseman, L. · Nature Medicine (2025)
Aday, J. S., Horton, D. M., Fernandes-Osterhold, G. et al. · Psychopharmacology (2024)
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