Treatment-resistant Depression (TRD)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERGroup integration therapy
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.
Sponsors
Joshua Rosenblat
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be deemed to have capacity to provide informed consent; * Must sign and date the informed consent form; * Stated willingness to comply with all study procedures; * Stated willingness to comply with group integration requirements (i.e., maintaining confidentiality of other group members and group etiquette); * Stated willingness to commit to attending all group sessions. Of note, participants who miss a group session will not be penalized, provided they have communicated their anticipated or unanticipated absence with the study therapist(s); * Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form, study questionnaires and group participation, as evaluated by study staff obtaining consent; * Met all the inclusion criteria and none of the
Exclusion criteria
of either the PSI-1V2 or Psilo-BD clinical trials. * Completed the Primary Endpoint measures as part of the PSI-1V2 or Psilo-BD clinical trials. * Participants who are actively receiving therapy outside of this study are eligible to participate, provided the external therapy they are receiving is not psilocybin-assisted group integration psychotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on Behavioural Engagement with Integration | From enrolment to the primary endpoint (Week 21) | Evaluated using the Integration Engagement Scale, a 12-item self-report rating scale, where higher scores indicate greater engagement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Depression Symptoms | From enrolment to the end of the program (Week 17) | Self-assessment of depression symptoms using the 16-Item Quick Inventory for Depression Symptomatology where higher scores indicate greater severity |
| Self-Reported Wellbeing | From enrolment to the end of the program (Week 17) | Self-assessment of psychological wellbeing using the 5-Item World Health Organization-Five Well-Being Index where higher scores indicate greater quality of life |
| Self-Reported Anxiety Symptoms | From enrolment to the end of the program (Week 17) | Self-assessment of anxiety symptoms using the Generalized Anxiety Disorder 7-Item where higher scores indicate greater severity. |
| Self-Report of the Intrapsychic Experience of Integration | From enrolment to the primary endpoint (Week 21) | Self-assessment of feeling harmonized and improved using the 12-item Experienced Integration Scale, where higher scores indicate greater improvements |
| Post-Psychedelic Growth | From enrolment to the primary end point (Week 21) | Self-report of positive changes following a psychedelic event using the Post-Psychedelic Growth Inventory, where greater scores indicate greater positive changes |
| Self-Reported Connectedness | From enrolment to primary endpoint (Week 21) | 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 |
Countries
Canada
Outcome results
None listed