Virtual Cognitive Behavioural Therapy for Psychosis

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual cognitive behavioral therapy (CBT) can assist individuals with schizophrenia-spectrum disorders who are currently experiencing active psychosis symptoms. Participants will either receive six months of virtual CBT sessions or continue with their usual care. Virtual CBT includes one-on-one sessions with a therapist via Zoom, and all necessary technology will be provided if needed. This trial suits those who have schizophrenia or a similar condition, are currently experiencing active symptoms, and can use a computer. As an unphased trial, this study offers the opportunity to explore innovative therapy options and contribute to advancing mental health treatments.

Do I have to stop taking my current medications for the 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 Virtual Cognitive Behavioural Therapy for Psychosis is safe?

Research has shown that cognitive behavioral therapy for psychosis (CBTp) is safe. Studies have found it helps with symptoms such as hallucinations and delusions. Even when delivered online, it remains effective and well-received by most patients. One study noted that a few participants discontinued the online therapy early, but most completed their sessions without issues. This suggests that online CBTp is generally manageable. Overall, evidence supports its safety and acceptability for individuals experiencing active symptoms of psychosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Virtual Cognitive Behavioural Therapy for Psychosis is unique because it delivers therapy directly to patients' homes using an online platform. This approach ensures accessibility for individuals who may have difficulty attending in-person sessions. Additionally, it supplements the standard care without requiring any changes to existing treatments, which could make it a versatile option for patients. Researchers are excited about this method as it combines the effectiveness of Cognitive Behavioural Therapy with the convenience of virtual delivery, potentially reaching a broader audience and improving adherence to mental health treatment.

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

Research has shown that Cognitive Behavioral Therapy for psychosis (CBTp) can improve symptoms in individuals with schizophrenia-related disorders. Studies have found that CBTp helps manage symptoms like hallucinations and delusions and teaches coping skills. A review of several studies found that CBTp has a noticeable impact, though it might not work for everyone. In this trial, participants will receive Virtual CBT for Psychosis through video calls, enabling participation from home. Overall, evidence suggests that Virtual CBT for Psychosis can effectively manage symptoms of psychosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael W Best, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04752449

Virtual Cognitive Behavioural Therapy for Psychosis Participants with schizophrenia-spectrum disorders who are experiencing active symptoms of psychosis will randomized to either receive 6 months of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11775488/

Effectiveness of a Videoconference-Based Cognitive ... In the West, cognitive behavioral therapy for psychosis (CBTp) has shown promise in improving positive symptoms and acquiring coping skills [4]. A meta-analysis ...

3. nature.com nature.com/articles/s41591-025-03880-8

Virtual reality-based versus standard cognitive behavioral ... This contrasts with meta-analysis evidence suggesting that a stronger behavioral component in CBT for psychosis is associated with larger ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-021-03473-y

Virtual reality cognitive-behavioural therapy ... - BMC Psychiatry Cognitive-behavioural therapy for psychosis (CBTp) is the primary psychological treatment, but the median effect size is only small to medium.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2215036618300531

Virtual-reality-based cognitive behavioural therapy versus ... TKJ Craig et al. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12532561/

Virtual reality-based versus standard cognitive behavioral ... In the VR-CBTp group, 24 participants (19%) discontinued treatment (that is, attended 1 to 9 sessions before dropping out) and 102 (81%) ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000374

A case series in using virtual-reality assisted CBTp for ... The results demonstrated that VR can be effectively integrated into therapy, and lead to improvements in social functioning.

8. formative.jmir.org formative.jmir.org/2025/1/e59540

Effectiveness of a Videoconference-Based Cognitive ... Background: Cognitive behavioral therapy for psychosis (CBTp) is not sufficiently widespread in clinical practice, although evidence has ...

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1379541/full

Application of a virtual reality-based cognitive-behavioural ... This study provides preliminary evidence that CBT+VRET is acceptable, safe, and initial data that bears on the question of effectiveness for ...