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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
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring cognitive behavioral therapy

Eligibility Criteria

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

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

    First Posted
    June 30, 2022
    Last Updated
    January 25, 2023
    Sponsor
    Lawson Health Research Institute
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    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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