Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions. If group integration therapy is beneficial, then it has the potential to reduce resources required per patient for psilocybin-assisted psychotherapy, thereby increasing the cost-effectiveness of the treatment. However, no research has been done to understand if and how group therapy can support psychedelic integration for people with mood disorders. Therefore, the purpose of this study is to explore the benefit of psilocybin-assisted group therapy and to determine if psychedelic group integration therapy is acceptable to people who have received psychedelic-assisted therapy for mood disorders.
This study is a phase II, single-arm, single-site, 21-week study evaluating efficacy, feasibility, and acceptability of psychedelic group integration therapy. Participants will join 10 group therapy sessions that will facilitate the integration of insights gained from PAP into their day-to-day lives. The study will explore pre- and post- intervention measures and integrate qualitative data with quantitative data to examine feasibility and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
The integration group will consist of 4-8 participants who have completed PAP in accordance with the primary clinical trial (PSI-1V2 or Psilo-BD, respectively). One to two therapist(s) delegated to provide PAP as part of the primary clinical trials will facilitate the group and will guide the group in exploring a new psychoeducation theme each week. There will be a total of 10 sessions, each lasting 90 minutes. During the sessions, participants will experiment with interpreting their psychedelic experience through different lenses, as it relates to their depression. The group will take a peer-support format with group members collaboratively cultivating personally optimized perspectives from their dosing sessions.
Toronto Western Hospital
Toronto, Ontario, Canada
Impact on Behavioural Engagement with Integration
Evaluated using the Integration Engagement Scale, a 12-item self-report rating scale, where higher scores indicate greater engagement.
Time frame: From enrolment to the primary endpoint (Week 21)
Self-Reported Depression Symptoms
Self-assessment of depression symptoms using the 16-Item Quick Inventory for Depression Symptomatology where higher scores indicate greater severity
Time frame: From enrolment to the end of the program (Week 17)
Self-Reported Wellbeing
Self-assessment of psychological wellbeing using the 5-Item World Health Organization-Five Well-Being Index where higher scores indicate greater quality of life
Time frame: From enrolment to the end of the program (Week 17)
Self-Reported Anxiety Symptoms
Self-assessment of anxiety symptoms using the Generalized Anxiety Disorder 7-Item where higher scores indicate greater severity.
Time frame: From enrolment to the end of the program (Week 17)
Self-Report of the Intrapsychic Experience of Integration
Self-assessment of feeling harmonized and improved using the 12-item Experienced Integration Scale, where higher scores indicate greater improvements
Time frame: From enrolment to the primary endpoint (Week 21)
Post-Psychedelic Growth
Self-report of positive changes following a psychedelic event using the Post-Psychedelic Growth Inventory, where greater scores indicate greater positive changes
Time frame: From enrolment to the primary end point (Week 21)
Self-Reported Connectedness
Self-assessment of sense of connectedness to self, others and the world using the Watts Connectedness Scale, where higher scores indicate greater feelings of connectedness
Time frame: From enrolment to primary endpoint (Week 21)
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