- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584215
Cognitive Behavioural Therapy-Informed Groups for Psychosis (CBTp)
October 7, 2024 updated by: Serena Wong, Lawson Health Research Institute
This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Can read/write in English
- Has positive symptoms of psychosis that are distressing to them
Exclusion Criteria:
- Inability to tolerate group participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Treatment group will receive cognitive behavioural therapy informed groups for psychosis.
|
Groups based on cognitive behavioural therapy for psychosis
|
|
No Intervention: Control
Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Outcomes in Routine Evaluation 10 (CORE-10)
Time Frame: Up to 2 months
|
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.
|
Up to 2 months
|
|
Process of Recovery Questionnaire (QPR)
Time Frame: Up to 2 months
|
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.
|
Up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms
Time Frame: Up to 2 months
|
A brief measure of positive symptoms of psychosis.
The minimum value is 7, the maximum values is 49.
Higher scores indicate a worse outcome.
|
Up to 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Questionnaire
Time Frame: Up to 2 months
|
Brief open-ended questions about program satisfaction.
Responses are qualitative.
|
Up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Serena Wong, PhD, Lawson Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2023
Primary Completion (Estimated)
January 2, 2024
Study Completion (Estimated)
January 2, 2024
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
October 14, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Estimated)
October 9, 2024
Last Update Submitted That Met QC Criteria
October 7, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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