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Recruiting NCT07121166

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

No phase Interventional Schizophrenia and Related Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tgCBFI programme, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Schizophrenia and Related Disorders. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study

Overview

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.

Interventions

  • Behavioral tgCBFI programme
    a six-week online group intervention programme for dyads of service users and caregivers
  • Behavioral Treatment as Usual (TAU)
    Integrated community psychiatric care with psychiatric outpatient follow-up

Primary outcome measures

  • Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES) [Time frame: From enrollment to twelve-week post-intervention follow-up]
Secondary outcome measures (5)
  • Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS) [Time frame: From enrollment to twelve-week post-intervention follow-up]
  • Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS) [Time frame: From enrollment to twelve-week post-intervention follow-up]
  • Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS) [Time frame: From enrollment to twelve-week post-intervention follow-up]
  • Service satisfaction of participants from the tgCBFI group as assessed by the Client Satisfaction Questionnaire (CSQ-8) [Time frame: within one week after the intervention]
  • Qualitative feedback from the participants in the tgCBFI group as assessed by focus group interviews [Time frame: within one month after the intervention]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 6 centers
  • ALOHA (Eastern) — Chai Wan
  • Kowloon Hospital — Kowloon City
  • Kwai Chung Hospital — Kwai Chung
  • United Christian Hospital — Kwun Tong
  • Queen Mary Hospital — Pokfulam
  • ALOHA (Wong Tai Sin) — Tsz Wan Shan

Identifiers

NCT: NCT07121166 · HSEARS20241014006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗