NCT05958758

A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients

An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The Roots to Thrive Society for Psychedelic Therapy · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End of Life

Interventions

Type	Name	Description
DRUG	Psilocybin-assisted therapy within a community of practice model (group administered)	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2023-07-25
• Last updated: 2023-07-25