Virtual Cognitive Behavioural Therapy for Psychosis

NCT04752449 | Completed

• 1 other identifier: 39916
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychotic Disorders; Schizophrenia

Keywords

cbt; psychosis; schizophrenia; cbtp; cognitive behavioural therapy; psychotherapy; virtual

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS is a 30-item semi-structured interview assessing positive, negative symptoms and general psychopathology. Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, 7 = extreme). The lowest score would be a 30 and the highest score would be 210. A higher score would indicate increased symptomology.

  Change from Baseline to Follow-up (6 months post treatment)

Secondary Outcomes (13)

• Personal and Social Performance Scale (PSP)

  Change from Baseline to Follow-up (6 months post treatment)

• The Psychotic Symptom Rating Scales (PSYRATS)

  Change from Baseline to Follow-up (6 months post treatment)

• Calgary Depression Scale for Schizophrenia (CDSS)

  Change from Baseline to Follow-up (6 months post treatment)

• The Questionnaire About the Process of Recovery (QPR)

  Change from Baseline to Follow-up (6 months post treatment)

• Beliefs About Paranoia Scale (BAPS)

  Change from Baseline to Follow-up (6 months post treatment)

Study Arms (2)

Virtual Cognitive Behavioural Therapy for Psychosis

EXPERIMENTAL

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.

Behavioral: Virtual Cognitive Behavioural Therapy for Psychosis

Treatment as Usual

NO INTERVENTION

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

Interventions

Virtual Cognitive Behavioural Therapy for Psychosis BEHAVIORAL

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.

Also known as: CBT, CBTp

Virtual Cognitive Behavioural Therapy for Psychosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Toronto: lead
• Ontario Shores Centre for Mental Health Sciences: collaborator

Study Sites (1)

University of Toronto Scarborough

Scarborough Village, Ontario, M1C 1A4, Canada

Location

Related Publications (28)

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  BACKGROUND

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• Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.

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MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Color Vision Defects

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael W Best, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be informed after their first assessment whether they were randomized to CBTp or TAU. Those in TAU are offered CBTp at the end of the study period. Assessors remain blind throughout the study and therefore do not partake in the treatment intervention. Due to the nature of the study, the treatment providers cannot be blinded as those they treat have clearly been randomized to the CBTp condition. The investigator is not blind to any of the randomization outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to receive either Virtual Cognitive Behavioural Therapy or to Treatment as Usual. All participants who receive Treatment as Usual will be offered CBT at the end of the study period.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: February 1, 2021
• Primary Completion: January 26, 2024
• Study Completion: January 10, 2025
• Last Updated: July 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)