Web-Based Insomnia Treatment for Spousal Dementia Caregivers (SHUTi-DC)

NCT07836491 — Not applicable, Not yet recruiting, 80 participants, University of Missouri-Columbia

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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

Registry	NCT07836491, acronym SHUTi-DC
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	University of Missouri-Columbia (Other); collaborators: National Institute on Aging (NIA)
Conditions	Insomnia
Interventions	SHUTi-DC, PE (Behavioral)
Dates	start 2027-01-01 (estimated), primary completion 2028-02-28 (estimated), completion 2028-05-31 (estimated), first posted 2026-09-23, last updated 2026-09-23

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
SHUTi-DC	Experimental	Behavioral: SHUTi-DC	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.
Patient Education (PE)	Active comparator	Behavioral: PE	Online sleep health education delivered as static text-based content in a single release, plus two adapted modules addressing the dementia caregiving context.

SHUTi-DC (Behavioral), also known as Sleep Healthy Using the Internet for Dementia Caregivers: An adapted, self-paced, web-based cognitive behavioral therapy for insomnia program for spousal ADRD caregivers. The program includes eight modules: six standard SHUTi CBT-I modules covering sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, plus two psychoeducational modules with dementia-specific content addressing dementia education, disease progression, caregiving routines, and heightened vigilance. Modules are asynchronous and completed over an eight-week period, with each 20 to 40 minute session unlocking weekly to encourage metered participation. Participants complete daily online sleep diaries that generate tailored sleep schedule recommendations.
PE (Behavioral), also known as Patient Education: An active control condition providing online sleep health information. Materials cover content similar to SHUTi, including insomnia prevalence and causes and basic strategies to reduce insomnia symptoms, but are simpler and primarily text-based and no interactive or video-based elements. All content is delivered at once rather than unlocking weekly. Participants also receive the adapted portions of Module 1 and Module 8 containing dementia-specific content tailored for spousal ADRD caregivers.

+Outcome measures

Primary outcomes

Change in Insomnia Severity Index (ISI) score [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.

Secondary outcomes

Change in sleep efficiency [During the 8-week intervention period]: Sleep efficiency is derived from the 11-item Consensus Sleep Diary, completed daily by participants in both conditions throughout the intervention period.
Change in Pre-Sleep Arousal Scale (PSAS) score [During the 8-week intervention period]: The Pre-Sleep Arousal Scale is a 16-item self-report measure of cognitive and somatic arousal at bedtime, completed by participants in both conditions.

Other outcomes

Change in midsleep timing regularity [During the 8-week intervention period]: Midsleep timing regularity is calculated as the standard deviation of midsleep time derived from the 11-item Consensus Sleep Diary, completed daily by participants in both conditions throughout the intervention period.
Change in Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16) Score [During the 8-week intervention period]: The DBAS-16 is a 16-item self-report measure of sleep-related beliefs and attitudes, completed by participants in both conditions.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Funding

NIH grants: P30AG086642