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

Conditions

• Insomnia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SHUTi-DC — BEHAVIORAL
  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
  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.

Study Details

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.

Key Dates

First listed

Sep 23, 2026

Start date

Jan 1, 2027

Status verified

Sep 2026

Primary completion

Feb 28, 2028

Completion

May 31, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Active Comparator: Patient Education (PE)
  Online sleep health education delivered as static text-based content in a single release, plus two adapted modules addressing the dementia caregiving context.

Primary Outcome Measure

Change in Insomnia Severity Index (ISI) score [ Time Frame: Baseline, weekly during the intervention period, and at a post-intervention follow-up conducted 6 weeks after the intervention ends ]

Central Contacts

• Eunjin Tracy, PhD
  3852454212
  [email protected]

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