NCT07408934Enrolling by invitation
A Trial of Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)
A Randomized Controlled Trial of Group Cognitive Behavioral Therapy (the Feeling Safe Programme) for Psychosis
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- Aug 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Diseases
- Schizophrenia
- NCT number
- NCT07408934
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Aug 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in the Feeling Safe Programme
Other illness
- Have a current primary diagnosis of substance use disorder or personality disorder
- Have an organic syndrome such as delirium, dementia, or amnesia
Other
- Current participation in individual or group CBT
- Acute psychotic episode
- A stated inability to refrain from using substances before/during study visits
- Have a moderate to severe intellectual disability
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Ottawa Mental Health Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.