Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families

March 29, 2023 updated by: Chak Fai Ma, Hospital Authority, Hong Kong

Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study

Cognitive behavioural family intervention (CBFI) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (CBT) into the family context. It builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family interpersonal relationship. Existing literature indicates that CBFI may be effective in improving positive and negative symptoms of people diagnosed with schizophrenia immediately following the programme. This mixed-method is to evaluate the feasibility and effectiveness of a CBFI programme for people with schizophrenia and their families in a local context. The findings may accumulate more evidence that CBFI is a brief and effective psychosocial intervention that is adapted to Hong Kong clinical settings.

Study Overview

Study Type

Interventional

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

  • Name: Chak Fai Ma, MSc
  • Phone Number: 8392 2959 8392
  • Email: macf@ha.org.hk

Study Locations

      • Hong Kong, Hong Kong
        • Kwai Chung Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Service users

  • Diagnosis of schizophrenia-spectrum disorders, based on clinical judgement by the treating clinicians
  • Aged 18-65
  • Able to communicate in Cantonese

Family caregivers

  • Aged above 18
  • Living with service users
  • Able to communicate in Cantonese
  • Nominated by the service users

Exclusion Criteria:

Service users

  • Having co-morbidity of learning disability
  • Organic/neurological conditions
  • Substance misuse disorder

Family caregivers

  • Having active psychiatric conditions
  • Looking after more than one family member suffering from chronic physical or mental illnesses

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: Cognitive behavioural family intervention
four-week, four-session CBT-based family intervention programme
Active Comparator: Usual group psychoeducation
Treatment as usual in the institution studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative feedback from the clinicians of the concerned wards
Time Frame: Immediate posttreatment
Programme evaluation interview
Immediate posttreatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive symptoms of service users
Time Frame: Immediate posttreatment
Psychotic Symptoms Rating Scales (PSYRATS); 11-item hallucination subscale ranging from 0 to 44; 6-item delusion subscale ranging from 0 to 24
Immediate posttreatment
Negative symptoms of service users
Time Frame: Immediate posttreatment
Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78
Immediate posttreatment
Expressed emotion by service users
Time Frame: Immediate posttreatment
Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48
Immediate posttreatment
Caregiving experience by family caregivers
Time Frame: Immediate posttreatment
Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264
Immediate posttreatment
Perceived care burden by family caregivers
Time Frame: Immediate posttreatment
Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50
Immediate posttreatment
Mood disturbance by family caregivers
Time Frame: Immediate posttreatment
Hospital Anxiety and Depression Scale (HADS); 7-item depression subscale ranging from 0 to 21; 7-item anxiety subscale ranging from 0 to 21
Immediate posttreatment
Qualitative feedback from the service users and their families
Time Frame: Immediate posttreatment
Semi-structured focus group interview
Immediate posttreatment

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Chak Fai Ma, MSc, Kwai Chung Hospital, Hong Kong

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)

January 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 17, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

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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