Cognitive Behavioral Therapy for Schizophrenia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Royal Ottawa Mental Health Centre
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

DM

Deanna Mercer, M.D.

Principal Investigator

Royal Ottawa Mental Health Centre

LM

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

I am willing and able to participate in the study and can sign the consent form.
I can read and write in English.
I want to learn how to manage my symptoms.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 24 weeks of Feeling Safe CBT for Psychosis therapy in a group format

24 weeks
Weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Feeling Safe CBT for Psychosis group therapyExperimental Treatment1 Intervention
Group II: Treatment-as-Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre

Lead Sponsor

Trials
24
Recruited
2,300+

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40480660/

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.

The 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.