InsomniaSHUTi-DCNCT07836491
Web-Based Insomnia Treatment for Spousal Dementia Caregivers (SHUTi-DC)
A study testing SHUTi-DC and PE in people with Insomnia, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- SHUTi-DC and PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Insomnia
- Being tested
- SHUTi-DC, PE
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTi-DCBehavioural
Also called 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.
PEBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SHUTi-DC |
| 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. Receives: Behavioral: PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, weekly during the intervention period, and at a post-intervention follow-up conducted 6 weeks after the intervention ends
Secondary outcomes (2)
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.
Measured: During the 8-week intervention period
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.
Measured: During the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Eunjin Tracy, PhD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836491
- Sponsor's protocol ID
- 2133987
- Other IDs
- P30AG086642
- Acronym
- SHUTi-DC
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results will be made available to qualified researchers. The dataset will include demographic and clinical characteristics, daily sleep diary data, weekly survey data, and outcome measures, together with a data dictionary. Direct identifiers will be removed and indirect identifiers will be modified or aggregated as needed to protect participant confidentiality, consistent with the informed consent under which data were collected.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07836491
- Acronym / sponsor ID
- SHUTi-DC / 2133987
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHUTi-DC | Experimental | Behavioral: SHUTi-DCParticipants 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: PEOnline sleep health education delivered as static text-based content in a single release, plus two adapted modules addressing the dementia caregiving context. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTi-DCAlso: Sleep Healthy Using the Internet for Dementia CaregiversAn 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. | Behavioural | SHUTi-DC |
| PEAlso: Patient EducationAn 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. | Behavioural | Patient Education (PE) |
Primary outcome
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
The Insomnia Severity Index assesses the nature, severity, and impact of insomnia. Scores of 8 or above indicate clinically significant insomnia symptoms.
2 secondary outcomes
Change in sleep efficiency
Time frame: During the 8-week intervention period
Change in Pre-Sleep Arousal Scale (PSAS) score
Time frame: During the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results will be made available to qualified researchers. The dataset will include demographic and clinical characteristics, daily sleep diary data, weekly survey data, and outcome measures, together with a data dictionary. Direct identifiers will be removed and indirect identifiers will be modified or aggregated as needed to protect participant confidentiality, consistent with the informed consent under which data were collected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi-DC and PE in people with Insomnia, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunjin Tracy, PhD (3852454212, eunjintracy@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.