Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans
Overview
- Phase
- Phase 2
- Intervention
- Psilocybin
- Conditions
- PTSD
- Sponsor
- Combat Stress
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- PTSD symptoms
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to PaP being designated as a "breakthrough treatment" by the FDA in the US. Despite indications that PaP may hold benefits in treating individuals with posttraumatic stress disorder (PTSD), this remains to be investigated. As such, the present study aims to examine the acceptability, feasibility, safety, and efficacy of PaP (psilocybin administered with psychotherapy) in treating PTSD in military veterans.
Detailed Description
Recent studies have shown that Psilocybin-Assisted Psychotherapy (PaP) for individuals with treatment-resistant depression can result in outcomes that exceed routine psychotherapy. Psilocybin may have a catalytic effect on the psychotherapeutic process, enhancing introspection and interoception. PaP may similarly benefit the treatment of posttraumatic stress disorder (PTSD). Research indicates high treatment drop-out rates (approximately 30%) among PTSD patients, and moderate remission rates (approximately 44%) 40 months after completing treatment. Furthermore, some veterans with PTSD have poorer treatment responses than members of the general public. This suggests that alternative treatment approaches may be required to support veterans who do not benefit from standard evidence-based approaches. This study aims to explore the acceptability, feasibility, safety and efficacy of PaP for veterans with PTSD. A total of eight military veterans will be recruited. The study involves two non-directive preparatory sessions, two dosing sessions of psilocybin, followed by 12 sessions of Cognitive Processing Therapy. It is hypothesised that PaP will result in a significant reduction in PTSD symptoms, as indicated by PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5; PCL-5) scores from baseline to one-month follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-65 years
- •Fluent in English (reading and speaking)
- •Has internet access via computer or tablet
- •Is able to commit to the study visits and treatment length
- •Can provide a contact (relative, close friend, other support person) who is able to accompany the participant to dosing visits
- •Agrees to inform researchers within 48 hours of any medical treatments or procedures
- •Can swallow pills
- •Agrees to lifestyle restrictions: not to consume alcohol within 24 hours prior to dosing, and to not consume more caffeine than usual
- •Agrees to not participate in any other clinical trials for the duration of the study
- •PCL-5 score ≥33
Exclusion Criteria
- •General exclusion criteria:
- •History of poor cooperation or unreliability
- •Engaged in compensation litigation whereby financial game would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
- •Any other current problems that may interfere with participation (e.g., availability, private space for sessions at home)
- •Has hearing impairment that could interfere with ability to participate in the study
- •Is unable to provide written informed consent
- •Has known hypersensitivity or previous allergic reaction to any constituent of psilocybin
- •Pregnant or breastfeeding
- •BMI \<18 or \>35 or non-consent for metric to be measured during assessment visit
- •Has been diagnosed with, or has first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to medical condition), or bipolar I disorder
Arms & Interventions
Psilocybin-assisted Psychotherapy
All participants will receive 25mg psilocybin (capsule, hard, oral administration) in two 8-hour psilocybin dosing sessions, followed by Cognitive Processing Therapy.
Intervention: Psilocybin
Outcomes
Primary Outcomes
Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- PTSD symptoms
Time Frame: Change from baseline PCL-5 score at one month follow up
Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- 5). Scores range from 0-80, with a higher score indicated a worse outcome.
Secondary Outcomes
- Difficulties with anger measured using the Dimensions of Anger Reactions (DAR-5)(Change from baseline DAR-5 score at one month follow up)
- Challenging aspects of experiences with psilocybin measured using the Challenging Experience Questionnaire(Administered at the end of dosing session two, week 5)
- Core features of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ)(Change from baseline ITQ score at one month follow up)
- General anxiety symptoms measured using the Generalised Anxiety Disorder (GAD-7)(Change from baseline GAD-7 score at one month follow up)
- Depression symptoms measured using the Patient Health Questionnaire (PHQ-9)(Change from baseline PHQ-9 score at one month follow up)
- Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)(Change from baseline SWEMWBS score at one month follow up)
- Perceived social support measured using the Oslo Social Support Scale(Change from baseline OSS score at one month follow up)