NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

Phase

N/A

Condition

Insomnia

Dementia

Treatment

NiteCAPP SHARES

NiteCAPP CARES

Clinical Study ID

NCT04896775

STUDY004494

Ages > 18
All Genders

Study Summary

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Eligibility Criteria

Inclusion

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

Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances forsleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking tooearly, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,

baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onseton 3+ nts. PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary careprovider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerateactigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder forwhich CBT-I is not recommended (e.g., apnea), 6. scoring <32 on Sleep Apnea scale, SleepDisorders Ques. Exclusion:

Exclusion

CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment [Telephone Interviewfor 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 majorpsychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severeuntreated psychiatric comorbidity, 7. psychotropic or other medications (e.g.,beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outsidecurrent trial.

Study Design

NiteCAPP SHARES

February 02, 2022

March 31, 2026

Study Description

Over the next 30 years, more than 10 million persons living with dementia in the US will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers (CG) and persons with dementia (PWD) alike, but increases caregiver risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol adapted for dementia caregivers and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia and improves mood (moderate to large effects). Given demands on caregiver time and limited availability of trained CBT-I providers, we developed a web-based version of this treatment (NiteCAPP) to increase accessibility of this efficacious treatment for rural dementia CGs. NiteCAPP will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. 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 that have 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 mechanisms - sleep, arousal and inflammation - thereby, returning sympathetic and HPA functioning to normal. Another novel aspect of the proposed trial is inclusion of behavioral strategies to target the PWD sleep. Objectives: The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Connect with a study center

University of South Florida
Tampa, Florida 33612
United States
Active - Recruiting
University of Missouri
Columbia, Missouri 65212
United States
Site Not Available

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