Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression

NCT07737990 | Enrolling By Invitation

• 1 other identifier: 26-5068
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment-resistant Depression (TRD)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to the primary endpoint (Week 21)

Secondary Outcomes (6)

• Self-Reported Depression Symptoms

  From enrolment to the end of the program (Week 17)

• Self-Reported Wellbeing

  From enrolment to the end of the program (Week 17)

• Self-Reported Anxiety Symptoms

  From enrolment to the end of the program (Week 17)

• Self-Report of the Intrapsychic Experience of Integration

  From enrolment to the primary endpoint (Week 21)

• Post-Psychedelic Growth

  From enrolment to the primary end point (Week 21)

Other Outcomes (2)

• Rates of recruitment and retention of participants

  From enrolment to the completion of the therapy program at week 17

• Satisfaction with the Program

  From the beginning of the program (Week 1) to the end of the program (Week 17)

Study Arms (1)

Group Integration Therapy

OTHER

Other: Group integration therapy

Interventions

Group integration therapy OTHER

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.

Group Integration Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• Active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past month;
• Withdrawal, dropout, loss to follow-up, or demonstrated significant study intervention non-compliance of either the PSI-1V2 or Psilo-BD clinical trials.
• Any behaviors that, in the opinion of the investigator, may interfere with the group therapy model (e.g., participants in acute crisis, demonstrated resistance to the therapeutic process of the main clinical trials, etc.);
• Participants who are actively receiving psilocybin-assisted group integration psychotherapy outside of the study.

Sponsors & Collaborators

• Joshua Rosenblat: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

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MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)