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Enrolling by Invitation

NCT Number: NCT07737990

Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression

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.

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Key information

Conditions

Treatment-resistant Depression (TRD) Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Impact on Behavioural Engagement with Integration

    Time frame: 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 outcomes

  1. Self-Reported Depression Symptoms

    Time frame: 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

  2. Self-Reported Wellbeing

    Time frame: 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

  3. Self-Reported Anxiety Symptoms

    Time frame: 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.

  4. Self-Report of the Intrapsychic Experience of Integration

    Time frame: 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

  5. Post-Psychedelic Growth

    Time frame: 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

  6. Self-Reported Connectedness

    Time frame: 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

Other outcomes

  1. Rates of recruitment and retention of participants

    Time frame: From enrolment to the completion of the therapy program at week 17

    Percentage of participants that agree to participate in the group therapy program, and the percentage of eligible participants who complete participation in the study.

  2. Satisfaction with the Program

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

    Self-assessment of program satisfaction using the 8-item Client Satisfaction Questionnaire, where higher scores indicate greater satisfaction.

Sponsors and collaborators

Lead sponsor

Joshua Rosenblat

Other

Registry information

Acronym: PSI-GROUP

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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