Cognitive Behavioural Therapy-Informed Groups for Psychosis (CBTp)
Primary Purpose
Psychosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy for Psychosis Groups
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring cognitive behavioral therapy
Eligibility Criteria
Inclusion Criteria:
- Can read/write in English
- Has positive symptoms of psychosis that are distressing to them
Exclusion Criteria:
- Inability to tolerate group participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Treatment group will receive cognitive behavioural therapy informed groups for psychosis.
Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis.
Outcomes
Primary Outcome Measures
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
The Clinical Outcomes in Routine Evaluation 10 is a short 10 item easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress. The minimum value is 0, the maximum value is 40, and higher scores indicate a worse outcome.
Process of Recovery Questionnaire (QPR)
The Process of Recovery Questionnaire is a 15 item questionnaire which was co-produced by people who experience psychosis and their accounts of recovery. The minimum value is 0, the maximum value is 60, and higher scores indicate a better outcome.
Secondary Outcome Measures
The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms
A brief measure of positive symptoms of psychosis. The minimum value is 7, the maximum values is 49. Higher scores indicate a worse outcome.
Full Information
NCT ID
NCT05584215
First Posted
June 30, 2022
Last Updated
January 25, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05584215
Brief Title
Cognitive Behavioural Therapy-Informed Groups for Psychosis
Acronym
CBTp
Official Title
Cognitive Behavioural Therapy-Informed Groups for Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 3, 2023 (Anticipated)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
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
This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.
Detailed Description
The majority of inpatients at Parkwood Institute Mental Health have symptoms of psychosis. In line with Health Quality Ontario standards for the treatment of psychosis, the investigators would like to implement and evaluate cognitive behavioural therapy for psychosis (CBTp) informed groups. The feasibility, acceptability, and preliminary efficacy of CBTp groups for inpatients will be examined. Pragmatically, the investigators propose to undergo training in CBTp, implement empirically-supported CBTp protocols developed for inpatients, track outcomes, and publish our findings. The investigators would also incorporate patient feedback to improve future iterations of the protocol. Such an undertaking would build research capacity in front line staff by encouraging engagement in CBTp group training, survey design, participant screening, data collection, analyses, and dissemination of findings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment group will receive cognitive behavioural therapy informed groups for psychosis.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy for Psychosis Groups
Intervention Description
Groups based on cognitive behavioural therapy for psychosis
Primary Outcome Measure Information:
Title
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
Description
The Clinical Outcomes in Routine Evaluation 10 is a short 10 item easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress. The minimum value is 0, the maximum value is 40, and higher scores indicate a worse outcome.
Time Frame
Up to 2 months
Title
Process of Recovery Questionnaire (QPR)
Description
The Process of Recovery Questionnaire is a 15 item questionnaire which was co-produced by people who experience psychosis and their accounts of recovery. The minimum value is 0, the maximum value is 60, and higher scores indicate a better outcome.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms
Description
A brief measure of positive symptoms of psychosis. The minimum value is 7, the maximum values is 49. Higher scores indicate a worse outcome.
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Satisfaction Questionnaire
Description
Brief open-ended questions about program satisfaction. Responses are qualitative.
Time Frame
Up to 2 months
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:
Can read/write in English
Has positive symptoms of psychosis that are distressing to them
Exclusion Criteria:
Inability to tolerate group participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serena Wong, PhD
Phone
519-455-5110
Ext
47537
Email
serena.wong@sjhc.london.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Julia MacKinley, MSc
Phone
519-455-5110
Ext
47495
Email
julia.mackinley@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena Wong, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25577190
Citation
Owen M, Sellwood W, Kan S, Murray J, Sarsam M. Group CBT for psychosis: a longitudinal, controlled trial with inpatients. Behav Res Ther. 2015 Feb;65:76-85. doi: 10.1016/j.brat.2014.12.008. Epub 2014 Dec 23.
Results Reference
background
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Cognitive Behavioural Therapy-Informed Groups for Psychosis
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