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Virtual Cognitive Behavioural Therapy for Psychosis

Primary Purpose

Psychotic Disorders, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Cognitive Behavioural Therapy for Psychosis
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring cbt, psychosis, schizophrenia, cbtp, cognitive behavioural therapy, psychotherapy, virtual

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The inclusion criteria is anyone who meets the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder, are also 18-65 years of age, know how to use a computer, are not abusing drugs or alcohol and can read and speak English. Participants must be experiencing active symptoms of psychosis as indicated on the PANSS.

Exclusion Criteria:

Exclusion criteria include anyone who has received CBT in the past 6 months, or anyone with a neurological disease or neurological damage that would make it difficult to participate in a talk therapy.

Sites / Locations

  • University of Toronto ScarboroughRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Cognitive Behavioural Therapy for Psychosis

Treatment as Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a semi-structured interview that will be delivered through Zoom by one of the listed graduate students under the supervision of a registered clinical psychologist.

Secondary Outcome Measures

Personal and Social Performance Scale (PSP)
The PSP assesses community functioning through a brief interview with the participant about their daily activities.
The Psychotic Symptom Rating Scales (PSYRATS)
The PSYRATS assesses frequency and distress associated with the experiences of hallucinations and delusions based on the PANSS interview.
Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS is an interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia.
The Questionnaire About the Process of Recovery (QPR)
The QPR is a self-report measure of recovery for people with psychosis.
Beliefs About Paranoia Scale (BAPS)
The BAPS assesses metacognitive beliefs about paranoia.
Beliefs About Voices Questionnaire (BAVQ)
BAVQ assesses metacognitive beliefs about voices.
Experiences Questionnaire (EQ)
The EQ assesses decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness.
Brief Core Schema Scale (BCSS)
. The BCSS assesses core beliefs that individuals hold about themselves and others.
Dysfunctional Attitude Scale (DAS)
DAS assesses dysfunctional beliefs.
Davos Assessment of Cognitive Biases Scale (DACOBS)
DACOBS assesses cognitive processing biases associated with psychosis.
Childhood Trauma Questionnaire (CTQ)
The CTQ assesses experiences of trauma during childhood.
Working Alliance Inventory (WAI)
The WAI is a measure completed by both the therapist and the client about the quality of the therapeutic relationship.
Psychological Distance Scaling Task (PDST)
A commonly used experimental task associated with cognitive processing biases in psychosis. The PDST gives measure of both how positive and negative a person views themselves, and how tightly held these beliefs are based on the clustering of the ratings.

Full Information

First Posted
February 8, 2021
Last Updated
January 19, 2023
Sponsor
University of Toronto
Collaborators
Ontario Shores Centre for Mental Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04752449
Brief Title
Virtual Cognitive Behavioural Therapy for Psychosis
Official Title
Virtual Cognitive Behavioural Therapy for Psychosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Ontario Shores Centre for Mental Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Schizophrenia-spectrum disorders are the most persistent, debilitating, and economically burdensome mental illnesses worldwide, and are associated with the greatest per-patient expense of all mental health conditions. Schizophrenia is associated with a 15-20 year decrease in life expectancy, 5-fold increase in likelihood of death by suicide, and a significant decrease in quality of life. Antipsychotic medications are the first line treatment for individuals with schizophrenia spectrum disorders and are prescribed to nearly every service-user. However, in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial (one of the largest antipsychotic trials in 1493 individuals with schizophrenia), medication effects on psychosocial functioning were small (d = 0.25). Thus, the primary treatment available to all individuals with schizophrenia does little to improve community functioning. This may partially be a result of the limited efficacy of antipsychotic medication to improve neurocognitive abilities, widely recognized as a core feature of schizophrenia, and one recommendation stemming from the CATIE trial was that "more intensive psychosocial rehabilitative services, including cognitive rehabilitation, may be needed to affect more substantial gains in functioning." Cognitive behavioural therapy (CBT) is a psychological intervention originally developed to treat depression, and subsequently adapted to treat schizophrenia spectrum disorders. CBT has demonstrated moderate treatment effects (d = 0.36 - 0.44) in multiple meta-analyses and is widely recommended for the treatment of schizophrenia in international guidelines. CBT involves clients learning to evaluate their cognitive content in order to develop more accurate representations of the world. CBT has proven effective for improving hallucinations, delusions, negative symptoms, and personal recovery. Despite the established efficacy of CBT delivered through in-person methods, most clinics have discontinued in-person treatments as a result of the COVID-19 pandemic and have moved to virtual delivery methods. While it has been assumed that virtual delivery of CBT is equivalent to in-person delivery, our recent systematic review demonstrated that there has never been a trial examining the efficacy of virtually delivered CBT for psychosis. Characteristics of schizophrenia such as paranoia, and disorganization already present challenges to psychological treatment and it is possible that this challenge will be further exacerbated by treatment delivery through virtual methods. Additionally, it is unclear the extent to which individuals with schizophrenia-spectrum disorders will be interested in receiving virtual CBT and capable of using the technology that is required. Thus the goals of the current study are two-fold: Examine the efficacy of virtually delivered CBT for schizophrenia-spectrum disorders to reduce symptoms and improve community functioning. Examine the feasibility and acceptability of virtually-delivered CBT for individuals with schizophrenia-spectrum disorders. 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 therapist for 1-hour per week for 6-months. Therapists will be either a registered clinical psychologist or a graduate student in clinical psychology under the supervision of a registered clinical psychologist. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia
Keywords
cbt, psychosis, schizophrenia, cbtp, cognitive behavioural therapy, psychotherapy, virtual

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Cognitive Behavioural Therapy for Psychosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants continue with their regular standard of care without the addition of virtual Cognitive Behavioural Therapy for Psychosis.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Cognitive Behavioural Therapy for Psychosis
Other Intervention Name(s)
CBT, CBTp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The PANSS is a semi-structured interview that will be delivered through Zoom by one of the listed graduate students under the supervision of a registered clinical psychologist.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Secondary Outcome Measure Information:
Title
Personal and Social Performance Scale (PSP)
Description
The PSP assesses community functioning through a brief interview with the participant about their daily activities.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
The Psychotic Symptom Rating Scales (PSYRATS)
Description
The PSYRATS assesses frequency and distress associated with the experiences of hallucinations and delusions based on the PANSS interview.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Description
The CDSS is an interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
The Questionnaire About the Process of Recovery (QPR)
Description
The QPR is a self-report measure of recovery for people with psychosis.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Beliefs About Paranoia Scale (BAPS)
Description
The BAPS assesses metacognitive beliefs about paranoia.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Beliefs About Voices Questionnaire (BAVQ)
Description
BAVQ assesses metacognitive beliefs about voices.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Experiences Questionnaire (EQ)
Description
The EQ assesses decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Brief Core Schema Scale (BCSS)
Description
. The BCSS assesses core beliefs that individuals hold about themselves and others.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Dysfunctional Attitude Scale (DAS)
Description
DAS assesses dysfunctional beliefs.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Davos Assessment of Cognitive Biases Scale (DACOBS)
Description
DACOBS assesses cognitive processing biases associated with psychosis.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Childhood Trauma Questionnaire (CTQ)
Description
The CTQ assesses experiences of trauma during childhood.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Working Alliance Inventory (WAI)
Description
The WAI is a measure completed by both the therapist and the client about the quality of the therapeutic relationship.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Psychological Distance Scaling Task (PDST)
Description
A commonly used experimental task associated with cognitive processing biases in psychosis. The PDST gives measure of both how positive and negative a person views themselves, and how tightly held these beliefs are based on the clustering of the ratings.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria is anyone who meets the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder, are also 18-65 years of age, know how to use a computer, are not abusing drugs or alcohol and can read and speak English. Participants must be experiencing active symptoms of psychosis as indicated on the PANSS. Exclusion Criteria: Exclusion criteria include anyone who has received CBT in the past 6 months, or anyone with a neurological disease or neurological damage that would make it difficult to participate in a talk therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael W Best, Ph.D.
Phone
6476896098
Ext
1
Email
m.best@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Best, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto Scarborough
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1C 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael W Best, PhD
Phone
6476896098
Ext
1
Email
m.best@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Michael W Best, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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