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

May 11, 2026 updated by: University of Calgary

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall objective of this study 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 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 (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration).

AIM 2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration).

The secondary efficacy outcomes will include measures of mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.

Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action.

A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33.

All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chantel T Debert
        • Principal Investigator:
          • Leah Mayo
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • The University of British Columbia - Okanagan Campus
        • Contact:
        • Principal Investigator:
          • Zachary Walsh
        • Principal Investigator:
          • Paul van Donkelaar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Minimum PCL-5 score of ≥ 33
  • Limited lifetime use of serotonergic hallucinogens
  • Ability to read/write English

Exclusion Criteria:

  • 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
  • Any notable abnormality on ECG or routine medical blood laboratory test
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Epilepsy with a history of seizures
  • Current or recent (within 12 weeks) participation in a clinical trial
  • Cognitive impairment (SLUMS score <20)
  • Suffered a moderate/severe TBI at least once in lifetime
  • Suffered a mild TBI within the last 6 months
  • Any other circumstances that, in the opinion of the investigators, compromises participant safety
  • Not compelled to enter treatment to avoid legal consequences

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session
Active Comparator: Low Dose
Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session
Drug: Psilocybin
See treatment arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A clinician-administered, 30-item structured interview to diagnose and assess severity of PTSD symptoms in patients. It is widely used and validated, and is considered the gold standard PTSD diagnostic tool.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S)
Time Frame: Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing
A self-reported, 9-item assessment of depressive symptoms using a recall period of the past 7 days. This tool elicits a total score ranging from 0-54, with higher scores indicating greater depression.
Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
A 7-item self-reported questionnaire for measuring the severity of generalized anxiety disorder. Individuals rate how often they have been bothered by seven listed problems and score their responses from 0 ("not at all") to 3 ("nearly every day"). Total scores for anxiety severity are: 0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21: severe anxiety
Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time Frame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
A self-reported, 16-item questionnaire used to assess severity of 16 commonly experienced PPCS symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PPCS symptom burden.
Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
The Acceptance and Action Questionnaire II (AAQ-II)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A 7-item questionnaire measuring psychological flexibility. Scores range from 0 to 49 with higher scores indicating greater psychological flexibility.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Cognitive Fusion Questionnaire (CFQ-7)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A 7-point Likert scale measuring cognitive fusion. Scores range from 0 to 49 with higher scores indicating greater fusion with one's thoughts.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
9. EuroQol-5D (EQ-5D-5L)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A self-report measure of 5 key life dimensions, designed to measure health-related quality of life.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Cognitive Flexibility Scale (CFS)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A 12-item Likert-scale designed to assess the ability to identify options and alternatives to a situation, flexibility in behaviour, and confidence in the flexible behaviour.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Digit Span Task (DS)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Digit Span Task (DS)is a measure of verbal short term and working memory designed to measure simple attention. This 1 to 3-min task required participants to repeat a series of digits increasing in length and is measured through direction of the task, longest sequence successfully complete, and total number of attempts.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The World Health Organization Disability Assessment Schedule 2.0 12-item survey (WHODAS)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A 12-item self-administered scale of disability across different diseases, countries, and cultures with higher scores indicating greater disability.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Pittsburgh Sleep Quality Index (PSI)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
A 19-item self-reported questionnaire which measures sleep patterns and quality. Items are scored 0 (no difficulty) to 3 (severe difficulty) with higher overall scores indicating poorer sleep quality
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Trail-Making Test (TMT)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
2. The Trail-Making Test (TMT) is a test of general cognitive function, designed to assess working memory, visual processing, visuospatial skills, selective and divided attention, processing speed, and psychomotor coordination. The measure for this 3 to 4-min task is the time required for accurate completion
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Berg's Card Sorting Task (BCST)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Berg's Card Sorting Task (BCST) is a set-shifting measure of cognitive flexibility modeled after the Wisconsin Card Sorting task.82 Participants must select the stimulus that is different from others based on feedback and adapt their responses once the criteria for correct choice switches. Perseverative errors are defined as the number of instances in which three incorrect responses are made based on a previous rule, and they are thought to reflect less cognitive flexibility (or cognitive rigidity).
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Choice Reaction Time (CRT)
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
The Choice Reaction Time (CRT) Test is a computerized cognitive task that measures attention, processing speed, and motor response by requiring participants to respond quickly and accurately to one of several possible stimuli. Changes in CRT performance may reflect improvements in attention and processing efficiency, key domains often affected by traumatic brain injury.
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood biomarkers
Time Frame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
To explore blood biomarkers related to PTSD, brain injury, inflammation, oxidative stress, and growth factors following psilocybin-assisted therapy
Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

University of British Columbia
Vancouver Island University

Investigators

  • Principal Investigator: Leah Mayo, PhD, Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
  • Principal Investigator: Pamela Kryskow, MD, CCFP, Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
  • Principal Investigator: Zachary Walsh, PhD, Professor, Department of Psychology, University of British Columbia
  • Principal Investigator: Paul van Donkelaar, PhD, Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
  • Principal Investigator: Sandy Shultz, PhD, The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB25-0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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