Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence (PsiPTSD)

This quadruple-blind, randomised controlled trial (n=76) will study the effects of psilocybin (25mg or 1mg) combined with Acceptance and Commitment Therapy (ACT) in adult survivors of intimate partner violence (IPV) with post-traumatic stress disorder (PTSD).

The study, sponsored by the University of Calgary, aims to assess whether a therapeutic dose of psilocybin (25mg) improves PTSD symptoms compared to a low-dose control (1mg). Secondary measures include evaluating the effects of psilocybin on quality of life, cognitive function, mood, anxiety, and emotional regulation. Participants, aged 18-65, must have experienced IPV at least six months before enrolment and meet PTSD diagnostic criteria.

Eligible participants will undergo a two-part screening process before randomisation into either the high-dose (n=38) or low-dose (n=38) psilocybin groups. They will complete a baseline assessment, a psychoeducation session, and a single psilocybin administration session, followed by 5-6 weekly ACT sessions. Outcome measures will be assessed at 1 week, 4 weeks, 3 months, and 6 months post-treatment.

The trial will also explore biomarkers related to PTSD and psilocybin’s mechanisms of action. The study is expected to begin in August 2025 and conclude by August 2029, with sites in Alberta and British Columbia, Canada.

Topic PTSD Depression Anxiety Neuroscience
Compound Psilocybin Placebo
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2025
End date 01 August 2029
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 76
Sex All
Age 18- 65
Therapy Yes

Trial Details

The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: Complete a 2 part screening process Attend a baseline assessment Complete a psychoeducation preparation session(s) Attend psilocybin administration session (receive high dose [25mg] or low dose psilocybin [1mg]) Complete 5-6 weekly sessions of ACT Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.

Trial Number NCT06885996

Sponsors & Collaborators

University of Calgary
The University of Calgary, located in Alberta, Canada, is a comprehensive academic and research institution.

Data attribution

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