Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
Sleep disturbances are common among informal caregivers of people with dementia and can negatively affect their physical and psychological well-being. This randomized controlled trial aims to evaluate the effectiveness of an 8-week telephone-coached sleep bibliotherapy program in improving sleep quality among informal caregivers of people with dementia. Participants will be randomly assigned to either a sleep bibliotherapy intervention group or an educational booklet control group. Outcomes including sleep quality, caregiving appraisal, dysfunctional beliefs about sleep, emotional distress, neuropsychiatric symptoms of care recipients, and quality of life will be assessed at baseline, immediately post-intervention, and 3 months post-intervention.
详细描述
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of telephone-coached sleep bibliotherapy for informal caregivers of people with dementia.
A total of 120 eligible caregivers will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive an 8-week telephone-coached sleep bibliotherapy program.
The control group will receive an educational booklet containing general health information and weekly check-in calls. Both groups will continue receiving usual community services.
Data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include caregiving appraisal, dysfunctional beliefs and attitudes about sleep, emotional distress, neuropsyatric symptoms of care recipients, and quality of life.
The findings will provide evidence regarding the effectiveness of a low-cost and easily disseminated intervention for improving sleep and well-being among caregivers of people with dementia.
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)
盲法说明
Outcome assessors will be blinded to group allocation throughout the study. Participants and intervention providers cannot be blinded due to the nature of the behavioral intervention.
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
- •a) aged 18 years or older; b) provide unpaid care to a family member with dementia; c) living with the patient or actively involved in the patient's care daily for a minimum of 4 hours/day for at least 6 months; d) endorse one or more sleep problems; e) having the sleep problem with an average of 3 or more nights per week during the past month; d) taking no medication for sleep or stabilized on current medication for at least 6 weeks; e) could be contacted by phone.
排除标准
- •a) report a prior diagnosis of primary sleep disorder (e.g., sleep apnoea); b) have a severe chronic illness that could cause their sleep problems (e.g., emphysema); c) receive medical, psychological, or psychiatric treatment for sleep disturbance or depression; d) have cognitive impairment; e) be included in another interventional study.
研究组 & 干预措施
Telephone-Coached Sleep Bibliotherapy
Participants receive an 8-week sleep bibliotherapy program consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching. The intervention integrates dementia caregiving education with behavioral and cognitive strategies for improving sleep.
干预措施: Telephone-Coached Sleep Bibliotherapy (Behavioral)
Educational Booklet
Participants receive an educational booklet containing general health information and weekly check-in telephone calls. The booklet does not include therapeutic sleep intervention components.
干预措施: Educational Booklet (Behavioral)
结局指标
主要结局
Sleep Quality
时间窗: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
次要结局
未报告次要终点