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

Primary Purpose

Schizophrenia, Psychosis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

tgCBFI

Usual psychiatric care

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tgCBFI

Usual psychiatric care

Arm Description

Outcomes

Primary Outcome Measures

Level of service satisfaction of service users and family caregivers

Feasibility, acceptability, and safety of the programme

Secondary Outcome Measures

Perceived expressed emotion of service users

Positive and negative symptoms of service users

Mood disturbance of family caregivers

Perceived care burden of family caregivers

Qualitative feedback from service users and family caregivers

Full Information

NCT ID

NCT05808244

First Posted

March 29, 2023

Last Updated

March 29, 2023

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

1. Study Identification

Unique Protocol Identification Number

NCT05808244

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Psychosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tgCBFI

Arm Type

Experimental

Arm Title

Usual psychiatric care

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

tgCBFI

Intervention Description

Six weekly sessions CBT-based family intervention programme

Intervention Type

Behavioral

Intervention Name(s)

Usual psychiatric care

Intervention Description

Integrated community psychiatric care with medical follow-up

Primary Outcome Measure Information:

Title

Level of service satisfaction of service users and family caregivers

Time Frame

Immediate posttreatment

Title

Feasibility, acceptability, and safety of the programme

Time Frame

Throughout the whole programme

Secondary Outcome Measure Information:

Title

Perceived expressed emotion of service users

Time Frame

up to 12-week follow up

Title

Positive and negative symptoms of service users

Time Frame

up to 12-week follow up

Title

Mood disturbance of family caregivers

Time Frame

up to 12-week follow up

Title

Perceived care burden of family caregivers

Time Frame

up to 12-week follow up

Title

Qualitative feedback from service users and family caregivers

Time Frame

Immediate posttreatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dennis Chak Fai Ma

dennis.cf.ma@polyu.edu.hk

12. IPD Sharing Statement

Learn more about this trial

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

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