Actively Recruiting
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Led by University of South Florida · Updated on 2025-03-28
60
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Family caregiver living with a person who has dementia
- Willing to be randomized in the study
- Able to read and understand English
- Diagnosed with insomnia
- Not currently taking sleep medications or stable on them for 6 or more weeks
- Insomnia complaints for 6 or more months
- Adequate opportunity and environment for sleep
- Has difficulty falling asleep, staying asleep, or waking too early
- Experiences daytime problems due to insomnia affecting mood, cognition, social, or work life
- Screening shows Insomnia Severity Index score of 11 or higher, or 9-10 with supporting sleep diary data
- Sleep diaries indicate more than 30 minutes of difficulty falling asleep or staying asleep on 3 or more nights
You will not qualify if you...
- Unable to provide consent
- Cognitive impairment with Telephone Interview for Cognitive Status (TICS) score less than 25 or Mini Mental State Examination (MMSE) score less than 26
- Sleep disorder other than insomnia, such as sleep apnea with apnea/hypopnea index over 15
- Bipolar disorder or seizure disorder
- Major psychiatric conditions other than depression or anxiety, including suicidal thoughts or psychosis
- Severe untreated psychiatric disorders
- Use of psychotropic or other medications (e.g., beta-blockers) that affect sleep
- Currently receiving non-drug treatments for sleep or mood outside this trial
- For persons with dementia: unable to consent personally or via legally authorized representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
Research Team
C
Christina S McCrae
CONTACT
R
Riley Stephens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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