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

March 29, 2023 updated by: Dennis Chak Fai Ma, The Hong Kong Polytechnic University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of service satisfaction of service users and family caregivers
Time Frame: Immediate posttreatment
Immediate posttreatment
Feasibility, acceptability, and safety of the programme
Time Frame: Throughout the whole programme
Throughout the whole programme

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tgCBFI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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