PTSD
Conditions
Keywords
PTSD, Veteran, Psilocybin-assisted Psychotherapy, Feasibility trial
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.
Interventions
DRUGPsilocybin
Product name: Psilocybin Pharmaceutical form: capsule, hard Dose number and units: 25 mg per day (8-hour dosing session) x 2 Route of administration: oral
Sponsors
The Watson Trust
Combat Stress
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years 2. Fluent in English (reading and speaking) 3. Has internet access via computer or tablet 4. Is able to commit to the study visits and treatment length 5. Can provide a contact (relative, close friend, other support person) who is able to accompany the participant to dosing visits 6. Agrees to inform researchers within 48 hours of any medical treatments or procedures 7. Can swallow pills 8. Agrees to lifestyle restrictions: not to consume alcohol within 24 hours prior to dosing, and to not consume more caffeine than usual 9. Agrees to not participate in any other clinical trials for the duration of the study 10. PCL-5 score ≥33 11. At least one unsuccessful evidence-based psychotherapy/pharmacotherapy for PTSD
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of PTSD measured using the Posttraumatic Stress Disorder Checklist For DSM-5 (PCL- PTSD symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Difficulties with anger measured using the Dimensions of Anger Reactions (DAR-5) | Change from baseline DAR-5 score at one month follow up | Scores range from 5-25, with a higher score indicating a worse outcome. |
| Depression symptoms measured using the Patient Health Questionnaire (PHQ-9) | Change from baseline PHQ-9 score at one month follow up | Scores range from 0-27, with a higher score indicating a worse outcome. |
| General anxiety symptoms measured using the Generalised Anxiety Disorder (GAD-7) | Change from baseline GAD-7 score at one month follow up | Scores range from 0-14, with a higher score indicating a worse outcome. |
| Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) | Change from baseline SWEMWBS score at one month follow up | Scores range from 7-35, with a lower score indicating a worse outcome. |
| Perceived social support measured using the Oslo Social Support Scale | Change from baseline OSS score at one month follow up | Scores range from 3-14, with a higher score indicating a worse outcome. |
| Challenging aspects of experiences with psilocybin measured using the Challenging Experience Questionnaire | Administered at the end of dosing session one, week 4 | Scores range from 5-25, with a higher score indicating a worse outcome. |
| Core features of PTSD and complex PTSD measured using the International Trauma Questionnaire (ITQ) | Change from baseline ITQ score at one month follow up | Scores range from 0 to 48 with a higher score indicating a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Experiences in Psychotherapy | Treatment end (at CPT session 12), week 8 | Experiences that may occur in therapy measured using the Adverse Experiences in Psychotherapy to assess feasibility |
| Retention rate | Study end (approximately 2 years) | Feasibility endpoint |
| Did Not Attend (DNA) rate | Study end (approximately 2 years) | Feasibility endpoint |
| Recruitment of target sample size (n = 8) | Study end (approximately 2 years) | Feasibility endpoint |
| Incidence of adverse events across the duration of the study | Study end (approximately 2 years) | Safety endpoint, calculated as total number of adverse events reported across the study. Adverse events as defined in the study protocol. |
| Hazardous and harmful alcohol use measured using the Alcohol Use Disorder Identification Test | Baseline | Background measure. Scores range from 0-40, with a higher score indicating a worse outcome. |
| Possible drug-related problems measured using the Drug Use Disorders Identification Test | Baseline | Background measure. Scores range from 0-44, with a higher score indicating a worse outcome. |
| Difficulties with moral injury in relation to a potentially morally injurious event measured using the Moral Injury Outcome Scale (MIOS) | Baseline | Background measure. Scores range from 0-56, with a higher score indicating a worse outcome. |
| Semi-structured qualitative interviews | Consenting participants will be contacted at one-month follow up. | Intervention acceptability and experiences of the study will be measured using semi-structured qualitative interviews |
Countries
United Kingdom
Contacts
Primary ContactProf. Dominic Murphy
Outcome results
None listed