The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session. Target population: The treatment team will treat a total of 64 patients who have: * a terminal diagnosis (experiencing end of life distress), * AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society.
Treatment will take place at the Snuneymuxw Traditional Medicines Clinic, 1984 Woobank Rd, Nanaimo, B.C.Research data will be coordinated and held through RedCap, hosted by Island Health. Data collection centres on 1) understanding the feasibility; 2) collecting safety data; 3) exploring the mental health impacts of a community of practice as the vessel for psilocybin-assisted therapy for those with end-of-life distress. There is a mixed method approach for data collection, including: * Collect attendance * Biomedical measures taken during psilocybin sessions (blood pressure, pulse, medications to manage side effects). * Quantitative Health and Wellness Questionnaires of participants before, within, immediately after, and six months after completion. * Qualitative Surveys and Exit Interviews.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
The community of practice is 10 weeks long, meeting virtually for 2 hours each week, in a structured process, run through the Roots to Thrive treatment program. The psilocybin-assited therapy sessions occur midway through the 10-week program.
Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs over the 10-week intervention period. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Time frame: Treatment intervention period: Weeks 1 through 10
Primary Outcome 2: Follow-up to Treatment Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs during the 30-day treatment intervention follow-up phase. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Time frame: Follow-up period: Weeks 10 through 14
Primary Outcome 3: Safety Monitoring: Biomedical measures - Pregnancy testing
A urine pregnancy test measuring beta-human chorionic gonadotropin (B-hCG) will be conducted on the pre-treatment targeted physical exam visit to ensure the participant is not pregnant. If the pregnancy test is positive, the participant will be unable to participate in the treatment intervention at Week 5 but will be invited to remain in group therapy interventions sessions (Weeks 1-10).
Time frame: Immediately prior to treatment intervention session (Week 5)
Primary Outcome 3: Safety Monitoring: Biomedical measures - Heart Rate
Vitals signs, including heart rate (beats per minute/BPM) will be measured before, during, and after the treatment intervention session.
Time frame: Treatment intervention session (Week 5)
Primary Outcome 3: Safety Monitoring: Biomedical measures - Blood Pressure
Vitals signs, including blood pressure (millimeters of mercury/mmHg) will be measured before, during, and after the treatment intervention session.
Time frame: Treatment intervention session (Week 5)
Feasibility Outcome 1: Attendance during study intervention.
Feasibility outcomes will be measured using standardized assessments of treatment retention (i.e., partucipant attendance) Treatment retention will be defined as attendance in 80 % of the CoP group therapy sessions (\>2 consecutive sessions) and attendance at the Week 5 psilocybin therapy session.
Time frame: Weeks 1-10
Feasibility Outcome 2: Post-treatment intervention Qualitative Survey
Upon completing the 10-week intervention period, all participants will complete the Roots to Thrive (RTT)-Psychedelic Assisted Therapy (PAT) Global QI Survey by answering seven (7) standard questions. Each participant will answer the same 7 questions. This survey will be administered by a member of the study team, and each question will be completed by the participant via online entry.
Time frame: End of treatment intervention period: Week 10
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