NCT05584215

Brief Summary

This is a feasibility study of cognitive behavioural therapy-informed groups for psychiatric inpatients with positive symptoms of psychosis.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

June 30, 2022

Last Update Submit

October 7, 2024

Conditions

Keywords

cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 2 months

  • 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.

    Up to 2 months

Secondary Outcomes (1)

  • The Positive and Negative Syndrome Scale (PANSS) - Positive Symptoms

    Up to 2 months

Other Outcomes (1)

  • Satisfaction Questionnaire

    Up to 2 months

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group will receive cognitive behavioural therapy informed groups for psychosis.

Behavioral: Cognitive Behavioural Therapy for Psychosis Groups

Control

NO INTERVENTION

Control group will be put on a waitlist to receive cognitive behavioural therapy informed groups for psychosis.

Interventions

Groups based on cognitive behavioural therapy for psychosis

Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can read/write in English
  • Has positive symptoms of psychosis that are distressing to them

You may not qualify if:

  • Inability to tolerate group participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Serena Wong, PhD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2022

First Posted

October 18, 2022

Study Start

June 3, 2023

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share