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

NCT05808244 | Unknown

• 1 other identifier: tgCBFI
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Schizophrenia; Psychosis

Outcome Measures

Primary Outcomes (2)

• Level of service satisfaction of service users and family caregivers

  Immediate posttreatment

• Feasibility, acceptability, and safety of the programme

  Throughout the whole programme

Secondary Outcomes (5)

• Perceived expressed emotion of service users

  up to 12-week follow up

• Positive and negative symptoms of service users

  up to 12-week follow up

• Mood disturbance of family caregivers

  up to 12-week follow up

• Perceived care burden of family caregivers

  up to 12-week follow up

• Qualitative feedback from service users and family caregivers

  Immediate posttreatment

Study Arms (2)

tgCBFI

EXPERIMENTAL

Behavioral: tgCBFI; Behavioral: Usual psychiatric care

Usual psychiatric care

ACTIVE COMPARATOR

Behavioral: Usual psychiatric care

Interventions

tgCBFI BEHAVIORAL

Six weekly sessions CBT-based family intervention programme

tgCBFI

Usual psychiatric care BEHAVIORAL

Integrated community psychiatric care with medical follow-up

Usual psychiatric care; tgCBFI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Service users
• have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
• live in hostel
• Family caregivers
• have active psychiatric conditions

Sponsors & Collaborators

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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Dennis Chak Fai Ma

CONTACT

dennis.cf.ma@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate (Mental Health)

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-03