Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression

Overview

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

• Other Group 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

Primary outcome measures

• Impact on Behavioural Engagement with Integration [Time frame: From enrolment to the primary endpoint (Week 21)]

Secondary outcome measures (6)

• Self-Reported Depression Symptoms [Time frame: From enrolment to the end of the program (Week 17)]
• Self-Reported Wellbeing [Time frame: From enrolment to the end of the program (Week 17)]
• Self-Reported Anxiety Symptoms [Time frame: From enrolment to the end of the program (Week 17)]
• Self-Report of the Intrapsychic Experience of Integration [Time frame: From enrolment to the primary endpoint (Week 21)]
• Post-Psychedelic Growth [Time frame: From enrolment to the primary end point (Week 21)]
• Self-Reported Connectedness [Time frame: From enrolment to primary endpoint (Week 21)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Toronto Western Hospital — Toronto

Publications

• Zhdanava M, Pilon D, Ghelerter I, Chow W, Joshi K, Lefebvre P, Sheehan JJ. The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States. J Clin Psychiatry. 2021 Mar 16;82(2):20m13699. doi: 10.4088/JCP.20m13699. PMID 33989464
• Wong S, Kwan ATH, Teopiz KM, Le GH, Meshkat S, Ho R, d'Andrea G, Cao B, Di Vincenzo JD, Rosenblat JD, McIntyre RS. A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review. J Affect Disord. 2024 Apr 1;350:698-705. doi: 10.1016/j.jad.2024.01.142. Epub 2024 Jan 18. PMID 38244804
• Scott F, Hampsey E, Gnanapragasam S, Carter B, Marwood L, Taylor RW, Emre C, Korotkova L, Martin-Dombrowski J, Cleare AJ, Young AH, Strawbridge R. Systematic review and meta-analysis of augmentation and combination treatments for early-stage treatment-resistant depression. J Psychopharmacol. 2023 Mar;37(3):268-278. doi: 10.1177/02698811221104058. Epub 2022 Jul 21. PMID 35861202
• Tyls, F., Palenicek, T., & Horacek, J. (2016). Neurobiology of the effects of psilocybin in relation to its potential therapeutic targets. In Preedy, V. R. (Ed.), Neuropathology of drug addictions and substance misuse: Volume 2: Stimulants, club and dissociative drugs, hallucinogens, steroids, inhalants and international aspects. (pp. 782-793). Elsevier eBooks. https://doi.org/10.1016/B978-0-12-80
• Trope A, Anderson BT, Hooker AR, Glick G, Stauffer C, Woolley JD. Psychedelic-Assisted Group Therapy: A Systematic Review. J Psychoactive Drugs. 2019 Apr-Jun;51(2):174-188. doi: 10.1080/02791072.2019.1593559. Epub 2019 Apr 5. PMID 30950777
• Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. PMID 25831962
• Tai SJ, Nielson EM, Lennard-Jones M, Johanna Ajantaival RL, Winzer R, Richards WA, Reinholdt F, Richards BD, Gasser P, Malievskaia E. Development and Evaluation of a Therapist Training Program for Psilocybin Therapy for Treatment-Resistant Depression in Clinical Research. Front Psychiatry. 2021 Feb 3;12:586682. doi: 10.3389/fpsyt.2021.586682. eCollection 2021. PMID 33643087
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171

Identifiers

NCT: NCT07737990 · 26-5068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗