NCT04632628 · RECRUITING
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
This trial is testing a web-based version of Cognitive Behavioral Therapy for Insomnia, called NiteCAPP, designed specifically for family caregivers of people living with dementia. It measures changes in sleep quality, fatigue, mood, and cognitive functioning. This is a Phase N/A behavioral study, meaning it is evaluating a structured program rather than a drug — focused on real-world feasibility and effectiveness.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-15