This pre-print review (s=33, 2023) examines reporting practices of psychosocial interventions in clinical trials involving psychedelic treatment. The findings reveal that many reports on psychedelic trials did not disclose basic details about the interventions; 33% didn’t mention the number of sessions, 45% didn’t indicate the duration of sessions, 42% didn’t state provider credentials, 52% didn’t mention if a therapy manual was used, 67% didn’t reference a manual available to readers, and 82% didn’t report the assessment of treatment fidelity.
Abstract of A Systematic Review of Reporting Practices in Psychedelic Clinical Trials
“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.”
Authors: William Brennan, Alex R Kelman & Alexander B. Belser
Summary of A Systematic Review of Reporting Practices in Psychedelic Clinical Trials
Psychedelic-assisted therapy treatments include both study drug and supportive psychological intervention, but the specific components of these treatments that contribute to their efficacy and safety remain understudied.
One reason for the gap in our collective understanding of PAT clinical trials is a general deficiency in reporting practices for the PI used in these trials. Without this information, a rigorous appraisal of PAT trial results is not possible.
Rationale for Increased Consideration of Psychosocial Interventions
Murphy and colleagues found that therapeutic alliance contributed to clinical outcomes in a PAT treatment involving two psilocybin administrations for moderate to severe depression. This study also showed how several key psychotherapeutic elements – therapeutic alliance, rapport, emotional breakthrough – can interact in a mutually reinforcing manner.
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Brennan, B., Kelman, A., & Belser, A. B. (2023, July 18). A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions. https://doi.org/10.31234/osf.io/2ab59