Tele-group Cognitive Behavioural Family Intervention for Individuals With Schizophrenia and Their Families

NCT ID: NCT07121166

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-07-31

Brief Summary

This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?

Detailed Description

Recent network meta-analyses revealed that family interventions were superior to other psychosocial interventions in relapse prevention of people with schizophrenia. The current approaches to family intervention for schizophrenia are to provide support and offer psychoeducation and skill training for family caregivers, such as family psychoeducation and mutual support groups, and work with the whole family, stressing family structure, interaction, and dynamics, such as systemic therapy. A previous meta-analysis revealed that familial expressed emotion (EE), particularly critical comments, is a robust predictor of schizophrenic relapse, and it is one of the therapeutic foci of the family intervention to benefit the recovery of service users with schizophrenia. A proposed cognitive model of caregiving suggested that cognitive reappraisal, including reattribution of self-control on caregiving and reattribution of service users' control on illness progression, is one of the recommended therapeutic components to assist family caregivers in relieving their mood disturbances as well as negative expressed emotion. A framework of cognitive behavioural therapy (CBT) for service users with psychosis and their family caregivers has also been suggested to improve the clinical outcomes of the service users and extend the individual CBT to the family group. Built upon these two mainstream approaches of behavioural and structural family interventions, cognitive behavioural family intervention (CBFI) focuses on cognitive appraisals in family relationships between service users and their families, aligning with the proposed cognitive model of caregiving in resolving the two negative attrition-emotion pathways. A previous meta-analysis indicates that CBFI is superior to treatment as usual (TAU) in reducing the severity of positive and negative symptoms of people with schizophrenia immediately following the intervention. Recent systematic reviews supported that telepsychiatry/telehealth is a feasible and acceptable approach for people with severe mental illness and their family caregivers. This tgCBFI programme is a brief, novel group CBT-based family intervention using a telehealth delivery mode (i.e., via Zoom) to care for people with schizophrenia and their family caregivers in the community.

Conditions

Schizophrenia and Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tgCBFI group

Participants in this group will receive a six-week online group intervention programme and integrated community psychiatric care with psychiatric outpatient follow-up.

Group Type: EXPERIMENTAL

tgCBFI programme

Intervention Type: BEHAVIORAL

a six-week online group intervention programme for dyads of service users and caregivers

Treatment as Usual (TAU) group

Participants in this group will receive integrated community psychiatric care with psychiatric outpatient follow-up

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Integrated community psychiatric care with psychiatric outpatient follow-up

Interventions

tgCBFI programme

a six-week online group intervention programme for dyads of service users and caregivers

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Integrated community psychiatric care with psychiatric outpatient follow-up

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• current diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians,
• aged 18-64, and
• able to read and write Chinese

• aged 18 or above,
• able to read and write Chinese,
• live with service users, and
• nominated by the service users

Exclusion Criteria

• having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
• living in a hostel

II. Family caregivers

• having active psychiatric conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

health bureau, hong kong

UNKNOWN

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Chak Fai Ma

Assistant Professor of Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Chak Fai Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Central Contacts

Dennis Chak Fai Ma, PhD

Role: CONTACT

dennis.cf.ma@polyu.edu.hk

852-27666555

Other Identifiers

HSEARS20241014006

Identifier Type: -

Identifier Source: org_study_id