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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065360
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Chak Fai Ma, Hospital Authority, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Behavioral: Cognitive behavioural family intervention (CBFI) Behavioral: Usual group psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cognitive behavioural family intervention Behavioral: Cognitive behavioural family intervention (CBFI)
4-week, 6-session CBT-based family intervention programme

Active Comparator: Usual group psychoeducation Behavioral: Usual group psychoeducation
Treatment as usual in the institution studied




Primary Outcome Measures :
  1. Qualitative feedback from the clinicians of the concerned wards [ Time Frame: Immediate posttreatment ]
    Programme evaluation interview


Secondary Outcome Measures :
  1. 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

  2. Negative symptoms of service users [ Time Frame: Immediate posttreatment ]
    Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78

  3. Expressed emotion by service users [ Time Frame: Immediate posttreatment ]
    Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48

  4. Caregiving experience by family caregivers [ Time Frame: Immediate posttreatment ]
    Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264

  5. Perceived care burden by family caregivers [ Time Frame: Immediate posttreatment ]
    Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50

  6. 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

  7. Qualitative feedback from the service users and their families [ Time Frame: Immediate posttreatment ]
    Semi-structured focus group interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065360


Contacts
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Contact: Chak Fai Ma, MSc 2959 8392 ext 8392 macf@ha.org.hk

Locations
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Hong Kong
Kwai Chung Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
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Principal Investigator: Chak Fai Ma, MSc Kwai Chung Hospital, Hong Kong
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Responsible Party: Chak Fai Ma, Registered Nurse (Psychiatric), Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT04065360    
Other Study ID Numbers: CBFI
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chak Fai Ma, Hospital Authority, Hong Kong:
Schizophrenia
Psychosis
Family intervention
Cognitive behavioural therapy
CBT
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders