About this trial
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.
Eligibility criteria
Qualifiers
Individuals of all sexes, gender identities, and ethnicities
Ages 19 to 65 years at the time of screening
At least 6 months since last IPV incident
A score of 1 on the Composite Abuse Scale with repetition of abusive events
Disqualifiers
Severe or moderate substance use disorder other than nicotine in past 6 months
Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)
Active suicidal ideation or serious attempt within the past 1 year.
Current pregnancy or nursing, trying to become pregnant
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
Sponsors and collaborators
University of Calgary
Lead sponsor
Vancouver Island University
Collaborator
University of British Columbia
Collaborator