Cognitive Behavioural Therapy for Psychosis

(EPIC Trial)

No longer recruiting at 1 trial location
MW
Overseen ByMichael W Best, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Toronto
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 examines how Cognitive Behavioural Therapy for psychosis (CBTp) affects the brain and thinking skills in individuals with conditions like schizophrenia. Researchers will use electroencephalography (EEG) to study brain activity and assess cognitive improvements over four months of therapy. The treatment includes weekly, one-hour, in-person sessions with a psychologist or trained graduate student. This trial is for individuals diagnosed with schizophrenia, schizoaffective disorder, or another psychotic disorder who are currently experiencing active psychosis symptoms. As an unphased study, this trial offers a unique opportunity to contribute to understanding how CBTp can enhance brain function and thinking skills.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Behavioural Therapy for Psychosis is safe?

Research shows that Cognitive Behavioural Therapy for psychosis (CBTp) is well-tolerated. Studies have found that CBTp is a common and trusted treatment in many Western countries, meaning professionals widely use it. While CBTp doesn't usually have specific side effects, it involves talking and working through thoughts with a trained therapist, which is generally safe for participants.

CBTp doesn't have the side effects that medications might have because it is a type of talk therapy. It focuses on changing thinking patterns to help manage symptoms.

For those considering joining a trial involving CBTp, evidence suggests it's a safe option. It helps people manage their symptoms without the risks associated with many drug treatments.12345

Why are researchers excited about this trial?

Cognitive Behavioural Therapy for Psychosis (CBTp) is unique because it provides a structured, manual-based approach specifically tailored for individuals experiencing psychosis, which is not typical of the usual medication-based treatments. Unlike antipsychotic medications that primarily address symptoms at a biochemical level, CBTp targets the psychological processes contributing to psychotic experiences, helping patients develop coping strategies and reduce distress. Researchers are excited about this treatment because it offers a complementary approach that enhances standard care without altering it, potentially leading to more holistic and sustainable outcomes for patients.

What evidence suggests that Cognitive Behavioural Therapy for Psychosis is effective for treating psychosis?

Research shows that Cognitive Behavioural Therapy for Psychosis (CBTp), which participants in this trial will receive, can help reduce symptoms of psychosis. Studies indicate that CBTp improves both general symptoms and specific ones like hallucinations and delusions. A review of several studies found small to medium improvements in these symptoms, with more noticeable benefits over time, especially for delusions. Another study suggested that CBTp reduces symptoms more effectively than other treatments. Overall, this evidence suggests that CBTp can be a helpful addition to regular care for people with psychosis.24678

Who Is on the Research Team?

MW

Michael W Best, Ph.D.

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who are currently experiencing symptoms of psychosis, including those with schizophrenia or schizoaffective disorder. Participants must be able to read and speak English and not have a history of drug or alcohol abuse. People with physical disabilities that prevent assessment participation, neurological diseases, significant medical illnesses affecting brain function, or a history of severe head injury cannot join.

Inclusion Criteria

You are currently experiencing severe symptoms of psychosis, as shown by a specific assessment called PANSS.
You do not use illegal drugs or drink alcohol excessively.
You have been diagnosed with schizophrenia, schizoaffective disorder or any other type of psychotic disorder.

Exclusion Criteria

Those with physical handicaps that would prevent them from engaging in assessment procedures
You have a neurological disease or have suffered from neurological damage.
You have a medical condition that can affect your ability to think and remember things.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioural Therapy for psychosis (CBTp) in individual sessions with a psychologist for 1-hour per week for 6 months

24 weeks
24 visits (in-person)

Follow-up

Participants are monitored for neurophysiological and neurocognitive outcomes after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioural Therapy for Psychosis
Trial Overview The study is testing the effects of Cognitive Behavioural Therapy for Psychosis (CBTp) on brain activity and cognitive functions in people with psychosis. Researchers will use EEG to monitor changes in brain waves before and after therapy over four months in an open-label pilot study involving twenty participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioural Therapy for psychosisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Recruited
1,125,000+

Ontario Shores Centre for Mental Health Sciences

Collaborator

Trials
15
Recruited
2,400+

Citations

The long-term effectiveness of cognitive behavior therapy ...These results demonstrate the positive and potentially enduring impact of psychological therapy on a range of meaningful outcomes for clients with psychosis.
Efficacy and Moderators of Cognitive Behavioural Therapy ...This IPD meta-analysis suggested that CBTp is efficacious in reducing total and general symptoms of psychosis compared to other interventions.
A systematic review examining factors predicting ...In the past two decades growing evidence has demonstrated the effectiveness of using CBT with a population experiencing psychosis. A recent review of the ...
Meta-analysis and Meta-regression of Cognitive Behavioral ...Findings indicate small-to-medium effects of CBTp for psychotic symptoms, with increasing effectiveness across time for delusions.
an umbrella review of meta-analyses of randomised ...Our results suggest that CBT has a small to medium effect on general and positive symptoms and functioning in schizophrenia spectrum disorders ...
Cognitive Behavioural Therapy for Psychosis - PubMed CentralTwo systematic reviews reported a pooled effect size for positive symptoms favouring CBT for psychosis at the end of treatment, compared with usual care.
Cognitive behavioural therapy for psychosis: The end of the ...Cognitive behavioural therapy (CBTp) is now a frontline intervention for people with or vulnerable to psychosis in many Western countries. A ...
Examining the feasibility of a crisis-focused Cognitive ...Cognitive Behavioural Therapy for psychosis (CBTp) is a psychological intervention that should be offered in the acute phase of psychosis.
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