NCT04632628 · University of South Florida
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
(NiteCAPP)
What this study 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.
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Dementia caregiver living with person with dementia
- willing to be randomized, 4. read/understand English
- insomnia diagnosis
- no prescribed or over-the-counter sleep meds or stabilized 6+ weeks. Insomnia:
- complaints for 6+ mos
- adequate opportunity and circumstances for sleep
- 1+ of the following: difficulty falling asleep, staying asleep, or waking too early
- daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
- Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10
- baseline diaries indicate \>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
Exclusion criteria
- unable to consent
- cognitive impairment \[Telephone Interview for Cognitive Status (TICS) \<25 or Mini Mental State Examination (MMSE) \<26\]
- sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15)\]
- bipolar or seizure disorder
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
- severe untreated psychiatric comorbidity
- psychotropic or other medications (e.g., beta-blockers) that alter sleep
- non-pharmacological tx for sleep or mood outside current trial. PERSONS WITH DEMENTIA Inclusion Criteria:
- Persons with dementia living with caregiver
- Have an eligible caregiver
- willing to be randomized Exclusion Criteria: • Person with dementia or legally authorized representative is unable to consent
Where
- Columbia, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations