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Could group talk boost the benefits of psychedelic therapy for depression?

NCT ID NCT07737990

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests whether group therapy sessions can help people with treatment-resistant depression better integrate the insights gained from psilocybin-assisted psychotherapy. Participants who have already completed psilocybin treatment will join small groups for ten weekly sessions, each exploring a different theme. The goal is to see if this approach is acceptable and whether it improves engagement with the integration process, potentially making the therapy more resource-efficient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin-assisted group integration psychotherapy
What this could lead to
If group therapy proves effective, it could make psilocybin-assisted psychotherapy more accessible and cost-effective for people with hard-to-treat depression.
What could go wrong
This is an early, small study without a control group, so results may not be definitive. Group dynamics could also be challenging for some participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.