Taking people in United StatesNo phase

Online sleep program for dementia caregivers who have insomnia

Tests an online insomnia therapy in caregivers of people with dementia.

Key facts

Who runs it: University of South Florida
Where: Columbia, United StatesSee the site
Trial code: NCT04632628
Registry title: Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Status: Recruiting
People taking part: 60 people, planned
Started: 14 Nov 2023
Expected to end: 30 Sept 2027
Type of study: Interventional
Treatments tested: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
Record updated: 15 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who care for and live with a person with dementia and have long-term insomnia. The person with dementia they live with can also join.

Age: 18 years and older
Sex: All
Disease stage: Caregivers: insomnia diagnosis with complaints for 6+ months, trouble falling asleep, staying asleep or waking too early, and daytime problems from it. Insomnia Severity Index score ≥11 or 9-10. Sleep diaries show more than 30 mins to fall asleep or awake after falling asleep on 3+ nights.
Earlier treatment: Caregivers cannot take prescribed or over-the-counter sleep medicines, unless the dose has been stable for 6+ weeks. They cannot get other non-drug treatment for sleep or mood outside this trial.

Main reasons for not taking part

Memory or thinking problems (TICS <25 or MMSE <26)
Another sleep disorder, such as sleep apnea (AHI >15)
Bipolar disorder or seizure disorder
Major mental illness other than depression or anxiety, or severe untreated mental illness
Medicines that change sleep, such as beta-blockers

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

18+ yrs
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
18+ yrs
Persons with dementia living with caregiver
Have an eligible caregiver
willing to be randomized

Who cannot take part

psychotropic or other medications (e.g., beta-blockers) that alter sleep
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
severe untreated psychiatric comorbidity
non-pharmacological tx for sleep or mood outside current trial; PERSONS WITH DEMENTIA
Person with dementia or legally authorized representative is unable to consent
unable to consent
other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)

Other criteria

CAREGIVER

Where in United States

University of MissouriColumbia, United StatesContact: Christina McCraeTaking people

About the trial

What the trial wants to find out

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.

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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).

The group in the trial

NiteCAPP: Online Cognitive Behavioral Therapy for InsomniaTreatment being tested
This is a pilot trial with one treatment condition (CBT-I).
Treatment: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)