Online cognitive behavioral therapy for insomnia in dementia caregivers
Official title: Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Run by University of South Florida · NCT04632628 · Data updated 2026-11-12
This study tests if an online therapy program can help caregivers of people with dementia sleep better and improve their mood.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT04632628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are caregivers aged 18 and older who are living with a person diagnosed with dementia and experiencing insomnia.
✕Probably not a fit
Patients who are unable to consent, have cognitive impairments, or suffer from sleep disorders other than insomnia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on providing a web-based cognitive behavioral therapy for insomnia (CBT-I) specifically designed for caregivers of individuals with dementia. It aims to address the high prevalence of insomnia among these caregivers, which can lead to negative health outcomes such as depression and anxiety. The intervention consists of a brief, four-session protocol that has been adapted for the unique challenges faced by dementia caregivers. The effectiveness of this online approach will be evaluated by measuring changes in insomnia symptoms and overall mood.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and mental health for caregivers of dementia patients.
How similar studies have gone: Previous studies have shown that cognitive behavioral therapy for insomnia is effective in various populations, suggesting potential success for this adapted approach in dementia caregivers.
Who can join: the full rules
Show full inclusion / exclusion criteria
CAREGIVER Inclusion Criteria: * 18+ yrs * Dementia caregiver living with person with dementia * willing to be randomized, 4. read/understand English * insomnia diagnosis * no prescribed or over-the-counter sleep meds or stabilized 6+ weeks. Insomnia: * complaints for 6+ mos * adequate opportunity and circumstances for sleep * 1+ of the following: difficulty falling asleep, staying asleep, or waking too early * daytime dysfunction (mood, cognitive, social, occupational) due to insomnia * Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10 * baseline diaries indicate \>30 mins of sleep onset latency or wake after sleep onset on 3+ nts. Exclusion Criteria: * unable to consent * cognitive impairment \[Telephone Interview for Cognitive Status (TICS) \<25 or Mini Mental State Examination (MMSE) \<26\] * sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15)\] * bipolar or seizure disorder * other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis) * severe untreated psychiatric comorbidity * psychotropic or other medications (e.g., beta-blockers) that alter sleep * non-pharmacological tx for sleep or mood outside current trial. PERSONS WITH DEMENTIA Inclusion Criteria: * 18+ yrs * Persons with dementia living with caregiver * Have an eligible caregiver * willing to be randomized Exclusion Criteria: • Person with dementia or legally authorized representative is unable to consent
Where it's running
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University of Missouri
Columbia, Missouri, United States Recruiting
Study contacts
- Principal investigator: Christina McCrae — University of Missouri-Columbia
- Study coordinator: Christina S McCrae
- Email: mccraec@health.missouri.edu
- Phone: 573-882-0982
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.