NCT07836491Not yet recruiting
Web-Based Insomnia Treatment for Spousal Dementia Caregivers (SHUTi-DC)
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- University of Missouri-Columbia
- Diseases
- Alzheimer disease
- NCT number
- NCT07836491
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jan 2027 to the primary completion date, 28 Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Parasomnia symptoms, including dream enactment or injurious nocturnal behaviors suggestive of REM sleep behavior disorder
- 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
Other
- Night-shift work, indicating primary circadian misalignment rather than insomnia
- Current behavioral or psychological treatment for insomnia
- Sleep difficulties fully attributable to caregiving tasks without underlying insomnia mechanisms
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.