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Can group CBT help quiet the voices and fears of psychosis?

NCT ID NCT07408934

Symptom relief Sponsor: The Royal Ottawa Mental Health Centre Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests a group version of the Feeling Safe Programme, a type of cognitive behavioral therapy for people with schizophrenia or schizoaffective disorder. The goal is to reduce distressing symptoms like paranoia and hallucinations and improve quality of life. Fifty participants will either receive the group therapy plus usual care or just usual care, and researchers will measure changes in symptoms, worry, and well-being.

What this could mean

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

Active substance
cognitive behavioral therapy (Feeling Safe Programme) in a group format
What this could lead to
If this works, it could provide an effective group therapy option to help people with schizophrenia feel safer and improve their quality of life.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply widely. Group therapy may not work as well as individual sessions, and benefits may vary.

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 50 people

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

Started

Aug 2024

Expected to finish

Dec 2027

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: * Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, (American Psychiatric Association, 2013), as assessed by a Royal staff psychiatrist or psychologist. * From the Outpatient Integrated Schizophrenia Recovery Program (includes the Outpatient service, Day Program, and Regional Psychosis Clinic) * Ability to read and write English * Able to talk openly about psychotic symptoms even if they don't recognize them as such. * Interested in learning ways to cope with symptoms * Able to participate regularly, for 75 minutes once per week, in person * Willingness and capacity to be a participant in the study as evidenced by a signed written informed consent Exclusion Criteria: * Current participation in individual or group CBT * Previous participation in the Feeling Safe Programme * Acute psychotic episode * Have a current primary diagnosis of substance use disorder or personality disorder * A stated inability to refrain from using substances before/during study visits * Have an organic syndrome such as delirium, dementia, or amnesia * Have a moderate to severe intellectual disability

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Conditions

The condition(s) this trial relates to.

delusional disorder Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

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

Schizophrenia and schizoaffective disorder

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

  • Royal Ottawa Mental Health Centre

    Ottawa, Ontario, K1Z 7K4, Canada

More trials for these conditions

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