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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
Primary endpoints removed 14 → 1 primary endpoints
See other at-risk trials from The Royal Ottawa Mental Health Centre

Record History

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2027 Primary endpoint(s) modified · Secondary endpoints: 3 to 12 · Study title shortened, about 1 wordv2 Show 3 more changesShow less
    • Primary endpoint(s) modified
    • Secondary endpoints: 3 to 12
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07408934
Lead Sponsor The Royal Ottawa Mental Health Centre
Conditions Schizophrenia and Schizoaffective Disorder
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov