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

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.

Conditions

• Post Traumatic Stress Disorder PTSD
• Intimate Partner Violence (IPV)

Interventions

DRUG

Psilocybin

See treatment arm description.

Sponsors & Collaborators

• Vancouver Island University

  collaborator UNKNOWN

• University of British Columbia

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Sandy Shultz, PhD · The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria

• Leah Mayo, PhD · Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine

• Pamela Kryskow, MD, CCFP · Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society

• Zachary Walsh, PhD · Professor, Department of Psychology, University of British Columbia

• Paul van Donkelaar, PhD · Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2028-08-01

Completion

2029-08-01

Countries

• Canada

Study Locations