- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065360
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
Status
Withdrawn
Conditions
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
-
-
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Hong Kong, Hong Kong
- Kwai Chung Hospital
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-
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
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Active Comparator: Usual group psychoeducation
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Treatment as usual in the institution studied
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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
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBFI
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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