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

Study Overview
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Brief Summary
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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. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers? 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? 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?

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

Conditions
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Schizophrenia, Psychosis

Intervention / Treatment
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* Behavioral: tgCBFI
* Behavioral: Usual psychiatric care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tgCBFI<br> | Behavioral: tgCBFI<br>* Six weekly sessions CBT-based family intervention programme<br>Behavioral: Usual psychiatric care<br>* Integrated community psychiatric care with medical follow-up<br>|
| Active Comparator: Usual psychiatric care<br> | Behavioral: Usual psychiatric care<br>* Integrated community psychiatric care with medical follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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