Effectiveness of a Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families: a Mixed-method Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)
研究概览
简要总结
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?
详细描述
Recent network meta-analyses revealed that family interventions were superior to other psychosocial interventions in relapse prevention of people with schizophrenia. The current approaches to family intervention for schizophrenia are to provide support and offer psychoeducation and skill training for family caregivers, such as family psychoeducation and mutual support groups, and work with the whole family, stressing family structure, interaction, and dynamics, such as systemic therapy. A previous meta-analysis revealed that familial expressed emotion (EE), particularly critical comments, is a robust predictor of schizophrenic relapse, and it is one of the therapeutic foci of the family intervention to benefit the recovery of service users with schizophrenia. A proposed cognitive model of caregiving suggested that cognitive reappraisal, including reattribution of self-control on caregiving and reattribution of service users' control on illness progression, is one of the recommended therapeutic components to assist family caregivers in relieving their mood disturbances as well as negative expressed emotion. A framework of cognitive behavioural therapy (CBT) for service users with psychosis and their family caregivers has also been suggested to improve the clinical outcomes of the service users and extend the individual CBT to the family group. Built upon these two mainstream approaches of behavioural and structural family interventions, cognitive behavioural family intervention (CBFI) focuses on cognitive appraisals in family relationships between service users and their families, aligning with the proposed cognitive model of caregiving in resolving the two negative attrition-emotion pathways. A previous meta-analysis indicates that CBFI is superior to treatment as usual (TAU) in reducing the severity of positive and negative symptoms of people with schizophrenia immediately following the intervention. Recent systematic reviews supported that telepsychiatry/telehealth is a feasible and acceptable approach for people with severe mental illness and their family caregivers. This tgCBFI programme is a brief, novel group CBT-based family intervention using a telehealth delivery mode (i.e., via Zoom) to care for people with schizophrenia and their family caregivers in the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. Individuals with schizophrenia-spectrum disorders
- •Inclusion Criteria:
- •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
排除标准
- •having co-morbidity of learning disability, organic/neurological conditions, or substance use disorder, and
- •living in a hostel
- •II. Family caregivers
- •Inclusion Criteria:
- •aged 18 or above,
- •able to read and write Chinese,
- •live with service users, and
- •nominated by the service users
- •Exclusion Criteria:
- •having active psychiatric conditions
研究组 & 干预措施
tgCBFI group
Participants in this group will receive a six-week online group intervention programme and integrated community psychiatric care with psychiatric outpatient follow-up.
干预措施: tgCBFI programme (Behavioral)
Treatment as Usual (TAU) group
Participants in this group will receive integrated community psychiatric care with psychiatric outpatient follow-up
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Expressed emotion experienced by the service users as assessed by the Concise Chinese Level of Expressed Emotion Scale (CCLEES)
时间窗: From enrollment to twelve-week post-intervention follow-up
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.
次要结局
- Positive and negative symptoms of service users as assessed by the Positive and Negative Syndrome Scale (PANSS)(From enrollment to twelve-week post-intervention follow-up)
- Perceived care burden of family caregivers as assessed by the Family Burden Interview Schedule (FBIS)(From enrollment to twelve-week post-intervention follow-up)
- Mood disturbances of family caregivers as assessed by the Hospital Anxiety and Depression Scale (HADS)(From enrollment to twelve-week post-intervention follow-up)
- Service satisfaction of participants from the tgCBFI group as assessed by the Client Satisfaction Questionnaire (CSQ-8)(within one week after the intervention)
- Qualitative feedback from the participants in the tgCBFI group as assessed by focus group interviews(within one month after the intervention)
研究者
Dennis Chak Fai Ma
Assistant Professor of Practice
The Hong Kong Polytechnic University