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

Primary Purpose

Schizophrenia, Psychosis

Status
Withdrawn
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Group Cognitive behavioural family intervention (CBFI)
Usual group psychoeducation
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Family intervention, Cognitive behavioural therapy, CBT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kwai Chung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioural family intervention

Usual group psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

Qualitative feedback from the clinicians of the concerned wards
Programme evaluation interview

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2019
Last Updated
March 29, 2023
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04065360
Brief Title
Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families
Official Title
Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19 pandemic
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis
Keywords
Schizophrenia, Psychosis, Family intervention, Cognitive behavioural therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural family intervention
Arm Type
Experimental
Arm Title
Usual group psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive behavioural family intervention (CBFI)
Intervention Description
four-week, four-session CBT-based family intervention programme
Intervention Type
Behavioral
Intervention Name(s)
Usual group psychoeducation
Intervention Description
Treatment as usual in the institution studied
Primary Outcome Measure Information:
Title
Qualitative feedback from the clinicians of the concerned wards
Description
Programme evaluation interview
Time Frame
Immediate posttreatment
Secondary Outcome Measure Information:
Title
Positive symptoms of service users
Description
Psychotic Symptoms Rating Scales (PSYRATS); 11-item hallucination subscale ranging from 0 to 44; 6-item delusion subscale ranging from 0 to 24
Time Frame
Immediate posttreatment
Title
Negative symptoms of service users
Description
Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78
Time Frame
Immediate posttreatment
Title
Expressed emotion by service users
Description
Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48
Time Frame
Immediate posttreatment
Title
Caregiving experience by family caregivers
Description
Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264
Time Frame
Immediate posttreatment
Title
Perceived care burden by family caregivers
Description
Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50
Time Frame
Immediate posttreatment
Title
Mood disturbance by family caregivers
Description
Hospital Anxiety and Depression Scale (HADS); 7-item depression subscale ranging from 0 to 21; 7-item anxiety subscale ranging from 0 to 21
Time Frame
Immediate posttreatment
Title
Qualitative feedback from the service users and their families
Description
Semi-structured focus group interview
Time Frame
Immediate posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chak Fai Ma, MSc
Organizational Affiliation
Kwai Chung Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwai Chung Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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