An interventional study of SHUTi-DC and PE in Insomnia, sponsored by University of Missouri-Columbia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
Among 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia — 4 open to participants now, 5 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · University of Missouri-Columbia.
Among the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia, this one is the 6th largest by planned enrollment, is the only one that started in 2027, is one of 18 with no phase, and was the 18th registered.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →4 of the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia are open now, in 1 country. Recruiting first, the newest first:
University of Missouri-Columbia · Sites in United States
University of Missouri-Columbia · Sites in United States
University of Missouri-Columbia · Sites in United States
By country, each count listing its studies:
Of the 386 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 204 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 80 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 59 across the 18 interventional studies. Of the 11 that completed or were terminated, 3 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.
2 of the studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04253691University of Missouri-ColumbiaSleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study | 2026-12-30 |
| NCT07333586University of Missouri-ColumbiaInsomnia and Insulin Resistance | 2027-06-01 |
Among the 18 studies in Sleep Initiation and Maintenance Disorders by University of Missouri-Columbia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: SHUTi-DC
Online sleep health education delivered as static text-based content in a single release, plus two adapted modules addressing the dementia caregiving context.
Behavioral: PE
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.
Also known as: Sleep Healthy Using the Internet for Dementia Caregivers
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.
Also known as: Patient Education
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 ends
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 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.
Time frame: During the 8-week intervention period
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 period
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 period
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning at the time of publication of the primary results. Data will remain available for at least 5 years thereafter.
Access criteria: Qualified researchers with an academic or institutional affiliation may request access. Requests must include a methodologically sound research proposal describing the planned analyses and a signed data use agreement. Requests will be reviewed by the study principal investigator, with input from co-investigators as needed. Approved requesters will receive a de-identified dataset with an accompanying data dictionary, along with the study protocol and statistical analysis plan, transferred through a secure institutional file transfer service. Data may be used only for the purposes described in the approved proposal and may not be redistributed to third parties.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Feb 2028, 13 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 13 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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