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

76 Participants
are divided into 2 treatment groups

Locations

2
University of CalgaryT2N 2T9, CalgaryAlberta, Canada
The University of British Columbia - Okanagan CampusV1V 1V7, KelownaBritish Columbia, Canada

Sponsors and collaborators

University of Calgary

Lead sponsor

Vancouver Island University

Collaborator

University of British Columbia

Collaborator