Schizophrenia Clinical Trial
Official title:
Effectiveness of Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families: A Mixed-method Study
NCT number | NCT04065360 |
Other study ID # | CBFI |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2021 |
Est. completion date | December 2022 |
Verified date | March 2023 |
Source | Hospital Authority, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2022 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kwai Chung Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hospital Authority, Hong Kong | The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative feedback from the clinicians of the concerned wards | Programme evaluation interview | Immediate posttreatment | |
Secondary | 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 | Immediate posttreatment | |
Secondary | Negative symptoms of service users | Brief Negative Symptom Scale (BNSS); 13-item ranging from 0 to 78 | Immediate posttreatment | |
Secondary | Expressed emotion by service users | Concise Chinese Level of Expressed Emotion Scale (CCLEES); 12-item ranging from 12 to 48 | Immediate posttreatment | |
Secondary | Caregiving experience by family caregivers | Chinese version of Experience of Caregiving Inventory (CECI); 66-item ranging from 0 to 264 | Immediate posttreatment | |
Secondary | Perceived care burden by family caregivers | Family Burden Interview Schedule (FBIS); 25-item ranging from 0 to 50 | Immediate posttreatment | |
Secondary | 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 | Immediate posttreatment | |
Secondary | Qualitative feedback from the service users and their families | Semi-structured focus group interview | Immediate posttreatment |
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