Web-based intervention for insomnia in rural dementia caregivers

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes

This study is testing a new online program to help rural caregivers of people with dementia improve their sleep and overall well-being.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT04896775 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are caregivers aged 18 and older who are living with a person with dementia and have a diagnosis of insomnia.

Not a fit: Patients who are currently using prescribed or over-the-counter sleep medications or have untreated sleep disorders for which CBT-I is not recommended may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and overall health for rural dementia caregivers, leading to better caregiving outcomes.

How similar studies have performed: Previous studies have shown that cognitive behavioral therapy for insomnia is effective in caregivers, suggesting that this web-based approach may also yield positive results.

Eligibility criteria

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 this trial is running

Tampa, Florida

• 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

Conditions Insomnia; Dementia; Dementia Caregiver