A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions

A systematic review of 33 published psychedelic clinical trials found that many reports inadequately describe the psychosocial interventions provided alongside the drugs. Over 80% did not report assessing treatment fidelity, more than half did not mention using a therapy manual, and nearly half omitted the duration or number of therapy sessions. This underreporting, worse than in non-psychedelic trials, undermines research standardization and the ability to understand how these interventions affect outcomes. The authors recommend improved reporting practices to clarify the role of psychological support in psychedelic treatment.

Study at a glance

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.