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

T

The Hong Kong Polytechnic University

Status

Not yet enrolling

Conditions

Schizophrenia and Related Disorders

Treatments

Behavioral: Treatment as Usual (TAU)
Behavioral: tgCBFI programme

Study type

Interventional

Funder types

Other

Identifiers

NCT07121166
HSEARS20241014006

Details and patient eligibility

About

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?

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

I. Individuals with schizophrenia-spectrum disorders

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

Exclusion Criteria:

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

II. Family caregivers

Inclusion Criteria:

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

Exclusion Criteria:

  • having active psychiatric conditions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

tgCBFI group
Experimental group
Description:
Participants in this group will receive a six-week online group intervention programme and integrated community psychiatric care with psychiatric outpatient follow-up.
Treatment:
Behavioral: tgCBFI programme
Treatment as Usual (TAU) group
Active Comparator group
Description:
Participants in this group will receive integrated community psychiatric care with psychiatric outpatient follow-up
Treatment:
Behavioral: Treatment as Usual (TAU)

Trial contacts and locations

0

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Central trial contact

Dennis Chak Fai Ma, PhD

Data sourced from clinicaltrials.gov

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