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临床试验/NCT05808244
NCT05808244已完成不适用

A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Level of service satisfaction of service users and family caregivers

研究概览

简要总结

This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows.

  1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
  2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme?
  3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Service users
  • •diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians
  • •aged 18 to 64
  • •able to communicate in Cantonese
  • •Family caregivers
  • •aged 18 or above
  • •able to communicate in Cantonese
  • •live with service users

排除标准

  • •Service users
  • •have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
  • •live in hostel
  • •Family caregivers
  • •have active psychiatric conditions

研究组 & 干预措施

tgCBFI

Experimental

干预措施: tgCBFI (Behavioral)

tgCBFI

Experimental

干预措施: Usual psychiatric care (Behavioral)

Usual psychiatric care

Active Comparator

干预措施: Usual psychiatric care (Behavioral)

结局指标

主要结局

Level of service satisfaction of service users and family caregivers

时间窗: Immediate posttreatment

Feasibility, acceptability, and safety of the programme

时间窗: Throughout the whole programme

次要结局

  • Positive and negative symptoms of service users(up to 12-week follow up)
  • Perceived care burden of family caregivers(up to 12-week follow up)
  • Perceived expressed emotion of service users(up to 12-week follow up)
  • Mood disturbance of family caregivers(up to 12-week follow up)
  • Qualitative feedback from service users and family caregivers(Immediate posttreatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Chak Fai Ma

Assistant Professor of Practice

The Hong Kong Polytechnic University

研究点 (1)

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