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

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia; Psychosis
• Interventions: Behavioral: tgCBFI; Behavioral: Usual psychiatric care

• Registration Number: NCT05808244
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study Start: 2023-04
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-01
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tgCBFI	Usual psychiatric care	-
Usual psychiatric care	Usual psychiatric care	-
tgCBFI	tgCBFI	-

Primary Outcome Measures

Name	Time	Method
Level of service satisfaction of service users and family caregivers	Immediate posttreatment
Feasibility, acceptability, and safety of the programme	Throughout the whole programme

Secondary Outcome Measures

Name	Time	Method
Positive and negative symptoms of service users	up to 12-week follow up
Perceived care burden of family caregivers	up to 12-week follow up
Perceived expressed emotion of service users	up to 12-week follow up
Mood disturbance of family caregivers	up to 12-week follow up
Qualitative feedback from service users and family caregivers	Immediate posttreatment