Psychedelic-assisted therapy has attracted considerable interest, but poor reporting of psychosocial interventions (PIs) in clinical trials obscures their role in treatment outcomes. This systematic review of 33 published psychedelic clinical trials since 2000 found that many reports omitted basic details: 33% did not report the number of sessions, 45% did not report session duration, 42% did not report provider credentials, 52% did not report use of a therapy manual, 64% did not reference an available manual, and 82% did not report assessing treatment fidelity. Compared with non-psychedelic trials, psychedelic trial reports underreport key PI items. The review indicates that underreporting is a widespread problem and recommends improved reporting practices to enhance research standardization and treatment outcomes.
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.
The EMBARK training program for session monitors in clinical trials of psychedelic treatments was developed iteratively by Cybin, Inc. The program has been used in two completed and three ongoing clinical trials. This article describes the three phases of development, including core components, successes, lessons learned, and rationale for changes. The most recent iteration, EMBARKCT, used in Phase 3 trials, incorporates artificial intelligence with expert human oversight to identify when session monitors need additional support and training. Recommendations for the field are also discussed.