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Clinical Trials in Canada / NCT07408934
Enrolling by invitation Not applicable

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

NCT07408934 · tracked via the Priya Life Science Canada tracker
Sponsor
The Royal Ottawa Mental Health Centre
Phase
Not applicable
Started
2024-08-16
Last updated
2026-08-12

Condition(s) studied

Schizophrenia and Schizoaffective Disorder

Investigational drug(s) / intervention(s)

Cognitive Behavioral Therapy for Psychosis

Cognitive Behavioral Therapy for Psychosis: Feeling Safe CBT: The treatment approach is modular and manualised. Group modules will include: Sleep (7 sessions), Worry (6 sessions), Self-Confidence (5 sessions) and Feeling Safe Enough (6 sessions), targeted at dropping safety behaviours in behavioural tests in order to reduce threat beliefs and build safety beliefs. Participants who experience auditory hallucinations will have the option to do the module: Feeling Safe Alongside Hearing Voices (5 sessions) individually. Clients will choose the modules they wish to participate in. They will be required to choose a minimum of 2 modules, and will be encouraged to do the Feeling Safe Enough module. The minimum number of sessions a participant can attend will be 10. The maximum number of group sessions participants can attend will be 24. Groups will run weekly for 75-90 minutes. Each CBT group will have approximately six participants. The same therapists will provide the individual therapy.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) — At baseline and at end of study arm (week 24)
    The World Health Organization Quality of Life - Brief Version (WHOQOL-BREF; WHOQOL Group, 1998) is a 26-item self-report questionnaire (with a scoring range 1-5) which assesses 4 domains of quality of life: physical health, psychological health, social relationships, and environment. It also includes a measure of overall quality of life and general health. Scores are converted to a 0-100 scale, where higher scores are indicative of better quality of life.

Trial sites (1)

FacilityCityRegionStatus
Royal Ottawa Mental Health Centre Ottawa Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07408934 on ClinicalTrials.gov ↗ ← All trials in Canada