An Early Phase 1 interventional study of Psilocybin-assisted therapy within a community of practice model (group administered) in End of Life, sponsored by The Roots to Thrive Society for Psychedelic Therapy. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by The Roots to Thrive Society for Psychedelic Therapy · Early Phase 1, Interventional, and Treatment
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:
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:
572 studies on the registry are indexed under Death; 111 are open to participants now.
This study's planned enrollment of 64 is below the median of 133 across 260 interventional studies indexed under Death.
Browse Death studies →This is the only study on the registry with The Roots to Thrive Society for Psychedelic Therapy as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Currently taking on a regular (e.g., daily) basis: >investigational agents, >medications that are MAO inhibitors >UDG modulators, and inhibitors of UGT1A9 and 1A10, aldehyde or alcohol dehydrogenase inhibitors, SSRI's, SNRI's.
Conditions requiring special medical consideration:
Psychiatric Exclusion Criteria:
(the following diagnoses must have been confirmed by a qualified psychiatrist or psychologist):
Other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
Bipolar I would require more in-depth investigation in relation to the history of manic episodes.
Group administered Psilocybin-assisted therapy
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.
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
Exploratory Outcome 1: Efficacy outcomes via self-report questionnaires: Adverse Childhood Events Questionnaire (ACE)
The Adverse Childhood Experience (ACE) Questionnaire is a widely used validated scale with 10-item self-report measures to identify how adverse childhood experiences such as abuse and neglect may impact one's life and development. The questionnaire assesses five personal types of childhood trauma and five are related to family members. The ACE will be administered at the Baseline study visit.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Exploratory Outcome 2: Efficacy outcomes via self-report questionnaires: Patient Health Questionnaire - 9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a widely used validated scale that is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders to measure severity of depression and response to treatment. The PHQ-9 will be administered at Baseline, Week 10 -Week 14 timepoints.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Exploratory Outcome 3: Efficacy outcomes via self-report questionnaires: Generalized Anxiety Disorder - 7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a widely recognized validated self-report measure scale consisting of items reflecting the symptom DSM criteria for generalized anxiety disorder and from existing anxiety scales to understand one's experience of generalized anxiety at Baseline, Week 10 -Week 14 timepoints.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Exploratory Outcome 4: Efficacy outcomes via self-report questionnaires: McGill Quality of Life Questionnaire - Extended (MQOL-E)
The Generalized Anxiety Disorder-7 (GAD-7) is a widely recognized validated self-report measure scale consisting of items reflecting the symptom DSM criteria for generalized anxiety disorder and from existing anxiety scales to understand one's experience of generalized anxiety at Baseline, Week 10 -Week 14 timepoints.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Exploratory Outcome 5: Efficacy outcomes via self-report questionnaires: Watts Connectedness Scale (WCS)
The Watts Connectedness scale is a new three-dimensional index of felt connectedness that measures the various aspects of connectedness such as connection to 'self', 'others', and 'world'. This validated self-report measure seeks to understand one's experience of connection. The WCS will be administered at Baseline, Week 10 -Week 14 timepoints.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
Exploratory Outcome 6: Efficacy outcomes via self-report questionnaires: Substance Use & Coping Behaviours Questionnaire
Participants will complete a brief series of questions around substance use and coping patterns including yes/no response options, type, frequency of various coping and substance use behaviours. This brief questionnaire will be administered at Baseline, Week 10-Week 14 study visit timepoints.
Time frame: -28 to day 1 of programming (Week 0-1) and once again during Follow-up period (Weeks 10 through 14)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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