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Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study
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?
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.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 1, 2025
Primary Completion Date
May 31, 2028
Completion Date
July 31, 2028
Last Updated
August 19, 2025
200
ESTIMATED participants
tgCBFI programme
BEHAVIORAL
Treatment as Usual (TAU)
BEHAVIORAL
Lead Sponsor
The Hong Kong Polytechnic University
Collaborators
NCT07419321
NCT05603104
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05671185