Cognitive Behavioral Therapy for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a therapy called the Feeling Safe Program, a type of cognitive behavioral therapy (CBT) designed to help people with schizophrenia manage symptoms like paranoia and delusions. The goal is to determine if this therapy is effective in group sessions, as it has shown promise in individual settings. Participants will either join the group therapy or continue with their usual treatment, with the option to switch to group therapy later. It suits those diagnosed with schizophrenia or related disorders who can attend weekly sessions and are open to discussing their symptoms. As an unphased trial, this study offers a unique opportunity to explore innovative therapy in a supportive group setting.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing treatment, as the study focuses on adding therapy rather than changing medication.
What prior data suggests that this group therapy is safe for individuals with schizophrenia?
Research shows that the Feeling Safe Programme, a therapy for psychosis, is generally well-received by patients. This program was designed to assist people with schizophrenia, particularly those experiencing persecutory delusions, such as paranoia or fear of harm from others. One study found that half of the participants overcame their fears after completing individual sessions of the Feeling Safe Programme, with these improvements lasting for at least a year.
Although no published results exist yet on the safety of the group format, the success of individual therapy suggests that group sessions might also be safe and effective. Group therapy can provide additional benefits, such as reducing feelings of isolation and being more affordable. Overall, current evidence supports the Feeling Safe Programme as a safe option for those seeking help with schizophrenia symptoms.12345Why are researchers excited about this trial?
Researchers are excited about the Feeling Safe Programme for schizophrenia because it offers a fresh approach to therapy. Unlike traditional treatments that often rely heavily on medication, this program uses Cognitive Behavioral Therapy (CBT) delivered in a group setting. It specifically targets issues like sleep, worry, and self-confidence, with tailored modules for those experiencing auditory hallucinations. By focusing on these individual aspects, it aims to empower participants and improve their overall sense of safety and well-being, offering a more holistic alternative to standard care options.
What evidence suggests that the Feeling Safe Programme in a group format could be effective for schizophrenia?
Research shows that Cognitive Behavioral Therapy (CBT) for psychosis, particularly the Feeling Safe Programme, can be highly effective for individuals with schizophrenia. One recent study found that half of the participants overcame feelings of persecution after receiving individual treatment with the Feeling Safe Programme, with these improvements lasting at least a year. In this trial, some participants will receive the Feeling Safe CBT for Psychosis group therapy, which has not yet been formally studied. Group therapy can be advantageous because it typically costs less and helps reduce feelings of isolation. Previous research suggests that group CBT for schizophrenia might outperform standard treatments, indicating that the Feeling Safe Programme could be promising in a group setting.13467
Who Is on the Research Team?
Deanna Mercer, M.D.
Principal Investigator
Royal Ottawa Mental Health Centre
Lisa Murata, BScN, MEd
Principal Investigator
Royal Ottawa Mental Health Centre
Are You a Good Fit for This Trial?
This trial is for individuals with schizophrenia or related disorders who can consent to participate, read and write English, discuss their symptoms openly, and are interested in coping strategies. They must be able to attend weekly 75-minute group sessions in person.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 24 weeks of Feeling Safe CBT for Psychosis therapy in a group format
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)
Trial Overview
The trial is testing the Feeling Safe Programme, a group cognitive behavioral therapy aimed at reducing distress from psychosis and improving functioning. It compares the effectiveness of this group therapy against usual treatment methods.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Feeling Safe CBT: Participants will receive up to 24 weeks of Feeling Safe CBT for Psychosis therapy. Group modules will include: Sleep (7 sessions), Worry (6 sessions), Self-Confidence (5 sessions) and Feeling Safe Enough (6 sessions). Participants who experience auditory hallucinations will have the option to do the module: Feeling Safe Alongside Hearing Voices (5 sessions) individually.
Treatment-as-Usual (TAU): Participants in the TAU arm will continue with their current treatment as decided by their treatment team. TAU is defined as interdisciplinary treatment provided by disciplines such as psychiatry, psychology, social work, nursing, occupational therapy, recreational therapy, and dietary. Participants who are randomly assigned to the TAU arm will be offered the CBT intervention after completion of the wait list arm (24-week wait period).
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Royal Ottawa Mental Health Centre
Lead Sponsor
Citations
A Pilot Trial of Group Cognitive Behavioral Therapy for ...
In a recent Cochrane systematic review of group cognitive behavioural therapy for schizophrenia, group CBT appeared to be better than standard ...
Efficacy of a 6-month supported online programme ...
The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale-Delusions.
3.
psy.ox.ac.uk
psy.ox.ac.uk/research/oxford-cognitive-approaches-to-psychosis/projects-1/the-feeling-safe-programmeThe Feeling Safe Programme
The Feeling Safe Programme is a new cognitive-behavioural treatment for patients with psychosis. Developed with over a decade's research.
protocol for a randomised controlled trial
The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale—Delusions. The secondary outcomes are other ...
A Two-Study Pooled Analysis of Individual Participant Data
This trial found that there was a trend towards CBTp being superior to antipsychotics on overall psychiatric symptoms (MD = -7.79; 95%CI, -16.02 ...
Testing the combination of Feeling Safe and peer counselling ...
We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions ...
Comparison of a theoretically driven cognitive therapy ...
The Feeling Safe Programme led to a significant reduction in persistent persecutory delusions compared with befriending.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.