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Completed

NCT Number: NCT05808244

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

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.

1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers? 2. 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? 3. 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?

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Key information

Conditions

Schizophrenia Mental Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kowloon Hospital

Kowloon, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tgCBFI

Behavioral

Six weekly sessions CBT-based family intervention programme

Usual psychiatric care

Behavioral

Integrated community psychiatric care with medical follow-up

Primary outcomes

  1. Level of service satisfaction of service users and family caregivers

    Time frame: Immediate posttreatment

  2. Feasibility, acceptability, and safety of the programme

    Time frame: Throughout the whole programme

Secondary outcomes

  1. Perceived expressed emotion of service users

    Time frame: up to 12-week follow up

  2. Positive and negative symptoms of service users

    Time frame: up to 12-week follow up

  3. Mood disturbance of family caregivers

    Time frame: up to 12-week follow up

  4. Perceived care burden of family caregivers

    Time frame: up to 12-week follow up

  5. Qualitative feedback from service users and family caregivers

    Time frame: Immediate posttreatment

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Kowloon Hospital, Hong Kong
  • Nethersole Institute of Continuing Holistic Health Education
  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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