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

ConditionsPost Traumatic Stress Disorder PTSD Intimate Partner Violence (IPV)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Calgary

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Psilocybin
Drug
See treatment arm description.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: High DoseExperimental treatment 0 interventions

Group B: Low DoseActive comparator 1 intervention

Trial outcomes

Primary outcomes

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

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.

Time frame

Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

PTSD Checklist for DSM-5 (PCL-5)

A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.

Time frame

Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing

Secondary outcomes

Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S)

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.

Time frame

Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing

Generalized Anxiety Disorder-7 (GAD-7)

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

Time frame

Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

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.

Time frame

Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing

The Acceptance and Action Questionnaire II (AAQ-II)

A 7-item questionnaire measuring psychological flexibility. Scores range from 0 to 49 with higher scores indicating greater psychological flexibility.

Time frame

Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

Other outcomes

Blood biomarkers

To explore blood biomarkers related to PTSD, brain injury, inflammation, oxidative stress, and growth factors following psilocybin-assisted therapy

Time frame

Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Vancouver Island University

Collaborator

University of British Columbia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: