NCT07408934

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Royal Ottawa Mental Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

With a lifetime prevalence rate of \~0.5%, schizophrenia is a serious psychiatric disorder characterized by negative (e.g., anhedonia, apathy) and positive symptoms (e.g., hallucinations, delusions) that can vary in presentation. Although treatments for schizophrenia and psychosis have improved significantly, up to 34% of clients do not respond to conventional pharmacological treatment, including first and second-generation antipsychotics. In addition, as treatment resistance in schizophrenia is defined as less than 20% improvement on standardized rating scales, and with only about 20% of individuals reporting favourable outcomes, a significant percentage of treatment responders will experience persistent symptoms. Persistent persecutory delusions in particular cause significant impairment of psychological well being, with 47% scoring lower than 2 standard deviations below the mean of non-clinical individuals. Thus, there is a need for additional treatment strategies to promote quality of life and meaningful recovery. Cognitive Behavioural Therapy (CBT) is comprised of a wide range of techniques and interventions, and is broadly described as a structured, symptom-focused, goal-oriented therapy that aims to improve quality of life by changing a patient's thoughts or thinking patterns considered to maintain problematic symptoms. There is consistent support for CBT treatment for a range of psychiatric and psychosocial difficulties including depression, anxiety disorders, substance abuse, eating disorders, and personality disorders. CBT for psychosis (CBTp) interventions have been developed to reduce distress associated with psychotic symptoms, promote hope, and increase functioning. Qualitative research embedded within trials demonstrates that when service users are exposed to high quality CBT-P, delivered by competent trial therapists, they have high satisfaction and experience it as recovery-orientated, collaborative and validating. The Feeling Safe Programme was recently developed by a team at University of Oxford. The aim was to develop a CBT treatment for people with schizophrenia that had a success rate for psychosis that was more similar to CBT treatments for anxiety disorders. Developed with over a decade's research, The Feeling Safe Programme has proved to be an effective psychological treatment for persecutory delusions. For example, in a recent randomized controlled trial, half of the outpatient participants recovered from their persecutory delusions after undergoing individual treatment through the Feeling Safe Programme, and these gains were maintained at 12 months. Specifically, The Feeling Safe Programme led to significant reductions in delusional conviction and severity. There is some evidence that group CBTp is an effective and promising intervention and group CBTp may be more cost effective than individual CBTp. In a recent Cochrane systematic review of group cognitive behavioural therapy for schizophrenia, group CBT appeared to be better than standard care or other psychosocial interventions on improving total symptoms of schizophrenia and global functioning. The authors also note that due to low sample sizes, no firm conclusions concerning the efficacy of group CBTp for people with schizophrenia can be made and that more high-quality research, reporting useable and relevant data is needed. This study would help to fill that need. Goals and Aims of the Study: While there is some limited evidence of the effectiveness of group CBT for schizophrenia, there are no published findings on the effectiveness of this Feeling Safe Programme delivered in a group format. The proposed study will explore the efficacy of the Feeling Safe Programme in a group format compared to treatment as usual (TAU). Further, it will explore the experiences of individuals participating in the Feeling Safe Programme delivered in a group format.

Conditions

• Schizophrenia and Schizoaffective Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-08-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Canada