Clinical TrialSingle-armTreatment-Resistant Depression (TRD)Enrolling by invitation

Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression

This Phase II, single-arm, single-site trial (n=65) will evaluate the efficacy, feasibility and acceptability of psilocybin-assisted group integration therapy for adults with treatment-resistant depression (TRD) who have completed psilocybin-assisted psychotherapy in one of two primary clinical trials. The study will assess behavioural engagement with integration from enrolment to the primary endpoint at Week 21. Participants will attend 10 weekly 90-minute group sessions, with 4–8 participants per group, facilitated by 1–2 therapists involved in their previous psilocybin-assisted psychotherapy. Sessions will use a peer-support format and explore psychoeducational themes to help participants interpret and apply insights from their psilocybin experiences to their depression and everyday lives. Pre- and post-intervention measures, alongside qualitative and quantitative data, will be used to assess outcomes.

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Target Enrollment
65 participants
Study Type
Phase II interventional
Design
Non-randomized

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Topic research: Treatment-Resistant Depression (TRD)Research in Canada

Detailed Description

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.

Study Arms & Interventions

Group integration therapy

experimental

Interventions

  • Compound
    • 10 sessions

    Unmatched intervention: Group integration therapy

Participants

Ages
18 – ?
Sexes
Male & Female

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.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment65 participants
  • Timeline
    Start: 2026-07-01
    End: 2030-06-30
  • Topic
    Treatment-Resistant Depression (TRD)

Study Team

Sponsors & Collaborators

    Investigators

    • JR
      Joshua Rosenblat

    Locations

    Toronto Western Hospital — Toronto, Ontario, Canada

    Recent activity

    • StartedPsilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression (NCT07737990)

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