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?

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.

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+