Virtual Cognitive Behavioural Therapy for Psychosis

Overseen By Michael W Best, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Neurological disease, Neurological damage, others

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

Compensation: Varies

Number of Visits: 24

Duration: 6 months

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants with schizophrenia-spectrum disorders who are experiencing active symptoms of psychosis will randomized to either receive 6 months of individual cognitive behavioural therapy for psychosis or to receive treatment as usual. Participants will be assessed at baseline, 6 months, and 12 months.

Research Team

Michael W Best, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for individuals aged 18-65 with active symptoms of psychosis, who can use a computer and communicate in English. It's suitable for those diagnosed with schizophrenia or related psychotic disorders, provided they're not abusing substances or have had CBT in the last 6 months.

Inclusion Criteria

Experiencing active symptoms of psychosis as indicated on the PANSS

Knows how to use a computer

You have been diagnosed with schizophrenia, schizoaffective disorder or any other type of psychotic disorder.

Exclusion Criteria

You have received CBT (Cognitive Behavioral Therapy) within the last 6 months.

You have a neurological condition that would make it hard for you to participate in talk therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual virtual cognitive behavioural therapy sessions for 1-hour per week for 6 months

6 months

24 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Virtual Cognitive Behavioural Therapy for Psychosis

Trial Overview The study tests virtual cognitive behavioural therapy (CBT) for psychosis over six months against usual treatment. Participants will be randomly assigned to one of these two groups and evaluated at the start, after six months, and again after twelve months.

Participant Groups

Group I: Virtual Cognitive Behavioural Therapy for Psychosis Experimental Treatment 1 Intervention

CBT 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 virtually in the participant's home using the online platform Zoom which is PHIPA/PIPEDA compliant. If participants do not have the technology required for virtual sessions, then a tablet will be loaned to them for the duration of treatment. This treatment will be delivered in addition to usual care and no changes to usual care will be required.

Group II: Treatment as Usual Active Control 1 Intervention

Participants continue with their regular standard of care without the addition of virtual Cognitive Behavioural Therapy for Psychosis.

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+