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

NCT07121166 | Not Yet Recruiting

• 1 other identifier: HSEARS20241014006
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Schizophrenia and Related Disorders

Keywords

CBT; family intervention; schizophrenia; telehealth

Outcome Measures

Primary Outcomes (1)

• Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)

  It has twelve items using a four-point Likert scale with three subscales. The total score ranges from 12 to 48, and a higher score indicates a higher level of familial expressed emotion.

  From enrollment to twelve-week post-intervention follow-up

Secondary Outcomes (5)

• Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS)

  From enrollment to twelve-week post-intervention follow-up

• Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS)

  From enrollment to twelve-week post-intervention follow-up

• Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS)

  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)

  within one week after the intervention

• Qualitative feedback from the participants in the tgCBFI group as assessed by focus group interviews

  within one month after the intervention

Study Arms (2)

tgCBFI group

EXPERIMENTAL

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

Behavioral: tgCBFI programme

Treatment as Usual (TAU) group

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

Interventions

tgCBFI programme BEHAVIORAL

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

tgCBFI group

Treatment as Usual (TAU) BEHAVIORAL

Integrated community psychiatric care with psychiatric outpatient follow-up

Treatment as Usual (TAU) group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
• living in a hostel
• II. Family caregivers
• aged 18 or above,
• able to read and write Chinese,
• live with service users, and
• nominated by the service users
• having active psychiatric conditions

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• health bureau, hong kong: collaborator

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Dennis Chak Fai Ma, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Chak Fai Ma, PhD

CONTACT

852-27666555; dennis.cf.ma@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Practice

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share