NCT04632628: NiteCAPP

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Recruiting now NA Last updated 28 March 2025

What this trial tests

NA trial testing Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) in Insomnia Chronic in 60 participants. Currently enrolling.

Timeline

14 November 2023

Primary endpoint
31 March 2026

31 March 2027

Quick facts

Lead sponsor	University of South Florida
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	14 November 2023
Primary completion	31 March 2026
Estimated completion	31 March 2027
Sites	1 location across United States

Drugs / interventions tested

• Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

Conditions studied

• Insomnia Chronic — all drugs for Insomnia Chronic →
• Dementia — all drugs for Dementia →

Sponsor

University of South Florida

Who can join

18 and older, any sex, with Insomnia Chronic or Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's 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 a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I 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 overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.

Objectives

1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.
2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.
3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study.
   McCrae CS, Curtis AF, Stearns MA, Nair N, et al · · 2023 · cited 4× · PMID 37616032 · DOI 10.2196/45859