A Pilot Trial of Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)

Enrolling by invitation · Not applicable

Conditions studied: Schizophrenia and Schizoaffective Disorder

In brief

Schizophrenia is a serious psychiatric disorder characterized by delusions, hallucinations, negative symptoms and disorganized behaviour. Antipsychotic medication is the main treatment for schizophrenia, but many people do not respond to treatment, and most who do respond continue to have significant symptoms. Thus, there is a need for additional treatment strategies. Cognitive behavioural therapy for psychosis (CBTp) was developed to reduce distress associated with psychotic symptoms and improve functioning. The Feeling Safe Program is a CBTp treatment that was developed by a team at University of Oxford to address paranoia and the belief that one is at risk of being harmed by others (persecutory delusions). In a recent study, 50% of participants recovered from their persecutory delusions after individual Feeling Safe Program treatment and these gains were maintained at 12 months. Currently, there are no published findings on the effectiveness of this Programme delivered in a group format. Group formats can offer benefits such as ease of service delivery, cost-effectiveness and decreasing isolation. The proposed study will explore the efficacy of the Feeling Safe Programme in a group format compared to treatment as usual.

Key facts

Study ID: NCT07408934
Run by: The Royal Ottawa Mental Health Centre
People needed: 50
Starts: 2024-08-16
Expected to finish: 2026-12-31
Last updated by the study team: 2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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