R01AG066081

Web-Based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes - Project Summary

Compared to their urban counterparts, rural family dementia caregivers (CGs) face increased vulnerability to insomnia and related health concerns such as stress, inflammation, depression, anxiety, and cognitive disturbance. Cognitive Behavioral Treatment for Insomnia (CBT-I) holds promise for improving insomnia and these related concerns, but accessing it in rural areas is difficult. Our team developed Brief Telehealth CBT-I (Tele BCBT-I) tailored for CGs, which includes stress management and problem-solving techniques, and has shown improvements in sleep, arousal, mood, cognition, and inflammation (with small to large effects).

While telehealth improves accessibility, it is still burdensome for CGs due to inflexible scheduling and a scarcity of trained therapists. Therefore, further research is needed. Web delivery would increase access, and web CBT-I has been found to be efficacious in non-CG adults. However, it has not been tested in rural CGs. Using the NIH Stage Model flexible framework and Medical Research Council recommendations, we developed NITECAPP (web translation of our Tele BCBT-I protocol). Stage IA/B validation and testing have shown high feasibility and acceptability, as well as improvements in sleep, arousal, mood, burden, and cognition in a single-arm pilot study with rural CGs (N=5).

The proposed trial is the next logical step, which involves Stage II testing in a randomized controlled trial (N=100) to establish efficacy and further evaluate feasibility and acceptability. The Cognitive Activation Theory of Stress provides a framework for our basic premise that CGs experience insomnia, arousal, and inflammation that prompt sympathetic activation and hypothalamic-pituitary-adrenal (HPA) disruption, leading to downstream negative effects on health. The proposed trial tests the novel hypothesis that NITECAPP will improve CG health, mood, burden, and cognition by targeting their shared underlying mechanisms – sleep, arousal, and inflammation – thereby returning sympathetic and HPA functioning to normal.

Another novel aspect of the proposed trial is the inclusion of behavioral strategies to target the sleep of the person with dementia (PWD). Outcomes will be assessed at baseline, post-treatment, and two follow-ups (6 and 12 months) and include CG sleep, arousal, inflammation, health, mood, burden, cognition, and PWD sleep. The proposed study has four specific aims. Aim 1 focuses on the feasibility and acceptability of NITECAPP and WEBSHE (Sleep Hygiene Education – Active Web Comparator). Aims 2 and 3 examine NITECAPP's effects (versus WEBSHE) on CG primary/mechanistic (sleep, arousal, inflammation) and secondary outcomes (health, mood, burden, cognition), respectively. Because the PWD's sleep impacts CG sleep, Aim 4 examines NITECAPP's secondary effects on PWD sleep (objectively assessed). An exploratory aim examines the relationships between changes in CG primary and secondary outcomes and their potential mediators/moderators.

Public health implications: Demonstration that rural CGs can use NITECAPP to target sleep, arousal/stress, inflammation, and related health concerns has important implications for multiple stakeholders, including rural CGs, rural PWDs, their families, clinicians, and policymakers.

University Of South Florida

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Tampa, Florida 336124742 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the End Date has been extended from 03/31/26 to 03/31/27 and the total obligations have increased 346% from $762,338 to $3,399,055.