Tele-group Cognitive Behavioural Family Intervention for Individuals With Schizophrenia and Their Families (Definitive tgCBFI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe Hong Kong Polytechnic University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • tgCBFI programme

    Behavioral

    a six-week online group intervention programme for dyads of service users and caregivers

  • Treatment as Usual (TAU)

    Behavioral

    Integrated community psychiatric care with psychiatric outpatient follow-up

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: tgCBFI groupExperimental treatment 1 intervention
Group B: Treatment as Usual (TAU) groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to twelve-week post-intervention follow-up

Secondary outcomes

1

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.

Time frame
From enrollment to twelve-week post-intervention follow-up
2

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.

Time frame
From enrollment to twelve-week post-intervention follow-up
3

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.

Time frame
From enrollment to twelve-week post-intervention follow-up
4

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.

Time frame
within one week after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

health bureau, hong kong

Collaborator