Web-Based Insomnia Treatment for Spousal Dementia Caregivers (SHUTi-DC)
ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SHUTi-DC
BehavioralAn 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
BehavioralAn 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: SHUTi-DCExperimental treatment 1 intervention
Group B: Patient Education (PE)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) score
The Insomnia Severity Index assesses the nature, severity, and impact of insomnia. Scores of 8 or above indicate clinically significant insomnia symptoms.
Time frame
Baseline, weekly during the intervention period, and at a post-intervention follow-up conducted 6 weeks after the intervention endsSecondary outcomes
1
Change in sleep efficiency
Sleep efficiency is derived from the 11-item Consensus Sleep Diary, completed daily by participants in both conditions throughout the intervention period.
Time frame
During the 8-week intervention period2
Change in Pre-Sleep Arousal Scale (PSAS) score
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.
Time frame
During the 8-week intervention periodOther outcomes
1
Change in midsleep timing regularity
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.
Time frame
During the 8-week intervention period2
Change in Dysfunctional Beliefs and Attitudes about Sleep-16 (DBAS-16) Score
The DBAS-16 is a 16-item self-report measure of sleep-related beliefs and attitudes, completed by participants in both conditions.
Time frame
During the 8-week intervention periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Missouri-Columbia
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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