Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT05958758
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients
Sponsor:
The Roots to Thrive Society for Psychedelic Therapy
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: