Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
Status:
NOT_YET_RECRUITING
Trial end date:
2029-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE2
Details
Lead Sponsor:
University of Calgary
Collaborators:
University of British Columbia Vancouver Island University