About this trial
This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
current diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians,
aged 18-64, and
able to read and write Chinese
Disqualifiers
having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
living in a hostel
aged 18 or above,
able to read and write Chinese,
Trial design
Parallel
Treatments tested in this trial
tgCBFI programme
Behaviorala six-week online group intervention programme for dyads of service users and caregivers
Treatment as Usual (TAU)
BehavioralIntegrated community psychiatric care with psychiatric outpatient follow-up
Treatment groups
Trial outcomes
Primary outcomes
Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)
It has twelve items using a four-point Likert scale with three subscales. The total score ranges from 12 to 48, and a higher score indicates a higher level of familial expressed emotion.
Secondary outcomes
Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS)
It has thirty items using a seven-point Likert scale with three subscales. The subscale scores of positive and negative symptoms range from 7 to 49, while that of general psychopathology ranges from 16 to 112. A higher score indicates a higher level of severity of psychiatric symptoms.
Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS)
It has 25 items using a three-point Likert scale with six subscales. The total score ranges from 0 to 50. A higher score indicates a higher level of perceived family care burden.
Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS)
It comprises fourteen items using a four-point Likert scale with two subscales. The subscale scores of depression and anxiety range from 0 to 21. A higher score indicates a higher level of mood disturbance.
Service satisfaction of participants from the tgCBFI group as assessed by the Client Satisfaction Questionnaire (CSQ-8)
It consists of eight items using a four-point Likert scale. The total score ranges from 8 to 32. A higher score indicates a higher level of service satisfaction.
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
health bureau, hong kong
Collaborator