Cognitive Behavioural Therapy for Psychosis

(EPIC Trial)

Overseen By Michael W Best, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Neurological disease, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Despite overwhelming evidence for neurocognitive and neurophysiological factors involved in the etiology of psychosis, these factors have never been examined as mechanisms of improvement from CBTp. The first aim in the present study is to examine neurophysiological outcomes from CBTp using electroencephalography (EEG). The second aim is to examine neurocognitive outcomes from CBTp. This is an open-label pilot study. Twenty participants will receive CBTp and will be assessed at baseline and after 4 months.

Research Team

Michael W Best, Ph.D.

Principal Investigator

University of Toronto

Eligibility Criteria

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.

Can read and speak English

You do not use illegal drugs or drink alcohol excessively.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cognitive Behavioural Therapy for psychosis Experimental Treatment 1 Intervention

CBTp will be delivered according to an established manual that the PI has previously used successfully for in-person treatment. Treatment will consist of individual sessions with a psychologist employed by the University of Toronto for 1-hour per week for 6-months, or by one of the listed clinical graduate students under his supervision. All treatment will be delivered in-person. This treatment will be delivered in addition to usual care and no changes to usual care will be required.

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+