Web-based intervention for insomnia in rural dementia caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the efficacy of NiteCAPP, a web-based intervention designed to improve insomnia among rural dementia caregivers. The study will involve 100 caregiver and person with dementia (PWD) dyads, measuring both short-term and long-term effects of the intervention on caregiver sleep, health, mood, and cognitive function. The intervention is based on cognitive behavioral therapy for insomnia (CBT-I), which has been adapted for the unique needs of dementia caregivers. By providing flexible, at-home access to treatment, NiteCAPP aims to enhance the well-being of caregivers who often face significant challenges in managing their own health while caring for others.

Why it matters

Who can join: the full rules

Inclusion:

Caregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read/understand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.

* Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate \>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.

PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring \<32 on Sleep Apnea scale, Sleep Disorders Ques.

Exclusion:

CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment \[Telephone Interview for Cognitive Status (TICS) \<25\], 3. sleep disorder other than insomnia \[i.e., apnea (apnea/hypopnea index-AHI \>15)\], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.

Where it's running

• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Christina S McCrae — University of South Florida
• Study coordinator: Christina S McCrae
• Email: christinamccrae@usf.edu
• Phone: 813-974-1804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.