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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05808244
Collaborator
The University of Hong Kong (Other), Queen Mary Hospital, Hong Kong (Other), Kowloon Hospital, Hong Kong (Other), Nethersole Institute of Continuing Holistic Health Education (Other)
60
Enrollment
2
Arms
10.1
Anticipated Duration (Months)

Study Details

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.

  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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: tgCBFI
  • Behavioral: Usual psychiatric care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Level of service satisfaction of service users and family caregivers [Immediate posttreatment]

  2. Feasibility, acceptability, and safety of the programme [Throughout the whole programme]

Secondary Outcome Measures

  1. Perceived expressed emotion of service users [up to 12-week follow up]

  2. Positive and negative symptoms of service users [up to 12-week follow up]

  3. Mood disturbance of family caregivers [up to 12-week follow up]

  4. Perceived care burden of family caregivers [up to 12-week follow up]

  5. Qualitative feedback from service users and family caregivers [Immediate posttreatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dennis Chak Fai Ma, Clinical Associate (Mental Health), The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05808244
Other Study ID Numbers:
  • tgCBFI
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Apr 11, 2023