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NCT05808244 Clinical Trial

Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

Schizophrenia Clinical Trial

Official title:
A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05808244
Other study ID # tgCBFI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date February 2024

Study information
Verified date March 2023
Source The Hong Kong Polytechnic University
Contact Dennis Chak Fai Ma
Email dennis.cf.ma@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows. 1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers? 2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme? 3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Service users - diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians - aged 18 to 64 - able to communicate in Cantonese Family caregivers - aged 18 or above - able to communicate in Cantonese - live with service users Exclusion Criteria: Service users - have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder - live in hostel Family caregivers -have active psychiatric conditions

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• tgCBFI
Six weekly sessions CBT-based family intervention programme
• Usual psychiatric care
Integrated community psychiatric care with medical follow-up

Locations
Country Name City State
n/a

Sponsors (5)
Lead Sponsor Collaborator
The Hong Kong Polytechnic University Kowloon Hospital, Hong Kong, Nethersole Institute of Continuing Holistic Health Education, Queen Mary Hospital, Hong Kong, The University of Hong Kong

Outcome
Type Measure Description Time frame Safety issue
Primary Level of service satisfaction of service users and family caregivers Immediate posttreatment
Primary Feasibility, acceptability, and safety of the programme Throughout the whole programme
Secondary Perceived expressed emotion of service users up to 12-week follow up
Secondary Positive and negative symptoms of service users up to 12-week follow up
Secondary Mood disturbance of family caregivers up to 12-week follow up
Secondary Perceived care burden of family caregivers up to 12-week follow up
Secondary Qualitative feedback from service users and family caregivers Immediate posttreatment
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