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临床试验/NCT07836491
NCT07836491尚未招募不适用

Mechanisms of Action, Efficacy, and Feasibility of a Web-Based Cognitive Behavioral Therapy for Insomnia Intervention in Spousal Alzheimer's Disease and Related Dementias Caregivers

University of Missouri-Columbia0 个研究点目标入组 80 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Change in Insomnia Severity Index (ISI) score

研究概览

简要总结

Many people who care for a husband or wife with Alzheimer's disease or another dementia have trouble sleeping. About 40 to 60 out of every 100 spousal caregivers have insomnia, which means trouble falling asleep, trouble staying asleep, or waking up too early. Poor sleep can make it harder to handle stress, think clearly, and stay healthy.

Cognitive behavioral therapy for insomnia, or CBT-I, is the recommended treatment for insomnia. It helps people change the habits and thoughts that keep them awake. But CBT-I is hard for caregivers to get. There are not enough trained therapists, and caregivers often cannot leave home for appointments.

This study tests an online program called SHUTi-DC. It delivers CBT-I over the internet, so caregivers can use it at home whenever it fits their schedule. The program was adapted for people caring for a spouse with dementia.

The study will enroll 80 spousal caregivers who have insomnia symptoms. Half will be assigned to SHUTi-DC, which has eight weekly online modules that take 20 to 40 minutes each. The other half will receive a web-based sleep education program with general information about sleep health. A computer decides which program each person receives, similar to flipping a coin.

Everyone will answer questions about their sleep and well-being at the start of the study, each week during the program, and again six weeks after the program ends.

The researchers want to find out whether SHUTi-DC improves insomnia symptoms, how it works, and whether caregivers find the program helpful and easy to use.

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 (Participant)

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

  • •Age 18 years or older
  • •Spousal caregiver of a person with a clinician-diagnosed Alzheimer's disease or related dementia, with both partners cohabiting in the community
  • •Clinically meaningful insomnia symptoms, defined as an Insomnia Severity Index (ISI) score of 8 or higher
  • •Regular internet access and ability to independently use a computer or smartphone
  • •Fluent in English
  • •Residing within the United States

排除标准

  • •Parasomnia symptoms, including dream enactment or injurious nocturnal behaviors suggestive of REM sleep behavior disorder
  • •Night-shift work, indicating primary circadian misalignment rather than insomnia
  • •Current behavioral or psychological treatment for insomnia
  • •Severe psychiatric conditions, such as current mania or hypomania, that would interfere with participation or safety
  • •Significant cognitive impairment in the caregiver that would limit ability to engage in study procedures
  • •Medical conditions that substantially affect sleep or safety, including neurodegenerative disease, stroke, traumatic brain injury, epilepsy, severe respiratory disease, pregnancy, or breastfeeding
  • •Sleep difficulties fully attributable to caregiving tasks without underlying insomnia mechanisms

研究组 & 干预措施

SHUTi-DC

Experimental

Participants receive SHUTi-DC, an adapted version of the Sleep Healthy Using the Internet program consisting of eight weekly interactive online modules: six standard cognitive behavioral therapy for insomnia modules plus two dementia-specific modules. Each module takes 20 to 40 minutes.

干预措施: SHUTi-DC (Behavioral)

Patient Education (PE)

Active Comparator

Online sleep health education delivered as static text-based content in a single release, plus two adapted modules addressing the dementia caregiving context.

干预措施: PE (Behavioral)

结局指标

主要结局

Change in Insomnia Severity Index (ISI) score

时间窗: Baseline, weekly during the intervention period, and at a post-intervention follow-up conducted 6 weeks after the intervention ends

The Insomnia Severity Index assesses the nature, severity, and impact of insomnia. Scores of 8 or above indicate clinically significant insomnia symptoms.

次要结局

  • Change in sleep efficiency(During the 8-week intervention period)
  • Change in Pre-Sleep Arousal Scale (PSAS) score(During the 8-week intervention period)

研究者

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

Eunjin Tracy, PhD

Professor, AST

University of Missouri-Columbia

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