跳至主要内容
临床试验/NCT06413849
NCT06413849招募中不适用

Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
1
主要终点
Changes in depressive symptoms

研究概览

简要总结

This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.

详细描述

This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • provide unpaid care to a person diagnosed with early to moderate stage dementia;
  • provide at least 14 hours of care a week for at least 3 months
  • aged 18 years or above
  • able to read
  • have depressive symptoms
  • use a message application

排除标准

  • with an unstable physical or mental condition
  • with cognitive impairment
  • receiving medical, psychological, or psychiatric treatment for depression
  • have been included in another interventional study

结局指标

主要结局

Changes in depressive symptoms

时间窗: Pre-intervention, immediately post-intervention, 6 months post-intervention

Depressive symptoms will be measured with the Chinese version of the Depression Anxiety Stress Scale-21. It is a 4-point Likert scale consisting of 21 items that measure levels ofdepression, anxiety, and stress in participants. The total score ranges from 0-63, with the depression subscale score ranges from 0-21. Higher scores indicategreater severity of mental health problems.

次要结局

  • Changes in stress and anxiety(Pre-intervention, immediately post-intervention, 6 months post-intervention)
  • Changes in caregiving appraisal(Pre-intervention, immediately post-intervention, 6 months post-intervention)
  • Changes in quality of life(Pre-intervention, immediately post-intervention, 6 months post-intervention)
  • Changes in patient neuropsychiatric symptoms(Pre-intervention, immediately post-intervention, 6 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验