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Psilocybin-assisted massed cognitive processing therapy for chronic posttraumatic stress disorder: Protocol for an open-label pilot feasibility trial

Summary

This study tests whether psilocybin (a psychedelic compound) combined with intensive therapy can help treat chronic PTSD better than therapy alone. Fifteen patients with PTSD will receive one dose of psilocybin alongside 12 therapy sessions completed over a single week. Researchers will track feasibility, safety, symptom improvements, and use wearable devices to monitor physiological changes. The results will help determine whether larger trials should test this innovative combination therapy.

Background

Posttraumatic stress disorder (PTSD) affects approximately 3.9% of the general population. While massed cognitive processing therapy (CPT) has demonstrated efficacy for chronic PTSD, substantial proportions of patients remain symptomatic after treatment. Preliminary evidence suggests psilocybin may alleviate PTSD symptoms through mechanisms including reduced avoidance and decreased amygdala activity.

Objective

This open-label pilot study aims to evaluate the feasibility, tolerability, and preliminary efficacy of a single 25 mg psilocybin dose combined with one week of massed CPT in patients with chronic PTSD. Secondary objectives include assessing PTSD severity reduction and exploring putative mechanisms of change.

Results

This is a protocol paper describing planned methodology rather than completed results. The study is registered with ClinicalTrials.gov (NCT06386003) and recruitment began in August 2024. Expected feasibility benchmarks include recruitment of 2-3 participants monthly, withdrawal rates ≤20%, data completion >80%, and adherence >80%.

Conclusion

This open-label pilot trial represents an essential first step toward evaluating psilocybin-assisted massed CPT for chronic PTSD. Findings will guide design of a larger randomized controlled trial and potentially offer an alternative therapeutic option for individuals unresponsive to conventional PTSD treatments.
  • Published in:PLoS ONE,
  • Study Type:Clinical Trial - Open-Label Pilot Feasibility Study,
  • Source: PMID: 39823496, DOI: 10.1371/journal.pone.0313741
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