A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions
OpenAlex – July 18, 2023
Source: OpenAlex
Summary
A systematic review of 33 psychedelic clinical trials revealed significant underreporting of crucial psychosocial interventions, impacting treatment outcomes in Psychiatry and Clinical psychology. For example, 82% of trials did not assess treatment fidelity. Drawing from MEDLINE and PsycINFO, the systematic review used a Checklist based on Consolidated Standards of Reporting Trials to examine reporting of psychological intervention by psychotherapists, including those administering psilocybin. Such reporting gaps hinder standardization in Medicine and Psychedelics and Drug Studies, crucial for Mental Health Research Topics.
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.