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Web-based CBT-I for Dementia Caregivers with Insomnia

This study is testing a web-based program called Cognitive Behavioral Therapy for Insomnia (CBT-I) for dementia caregivers who have trouble sleeping. Many caregivers experience insomnia, which can lead to other health problems like depression and anxiety. CBT-I is a proven way to help people sleep better. This study will have 60 participants who are caregivers, aged 18 or older, live with the person with dementia, and have been diagnosed with insomnia for at least six months. You will complete four online CBT-I sessions. Researchers will measure how long it takes you to fall asleep, how often you wake up during the night, and your total sleep time after six weeks to see if the program helps improve your sleep.

Study design
This is an interventional study planning to enroll 60 participants. It is designed to test a web-based program.
What's involved
You will complete 4 web-based CBT-I sessions. Your sleep will be tracked using daily electronic sleep and pain diaries for 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your sleep will be measured for 6 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04632628

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Recruiting
NAAges 18+InterventionalTreatment
University of South Florida
~60 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Measured over 6 weeks
+10 more outcomes measured

Conditions

Insomnia Chronic
Dementia

Explore related trials

DementiaInsomnia

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Christina McCrae · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

Who to contact

Christina S McCrae
[email protected]
573-882-0982
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

Exclusion

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.

What this trial measures

  • Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency6 weeks

    Subjective sleep onset latency (time to fall asleep)

  • Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset6 weeks

    Subjective time awake after sleep onset

  • Daily Electronic Sleep and Pain Diaries - Total Sleep Time6 weeks

    Subjective total sleep time

  • Daily Electronic Sleep and Pain Diaries - Sleep Efficiency6 weeks

    Subjective sleep efficiency

  • Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness6 weeks

    Pain Intensity \& Unpleasantness

  • Daily Electronic Sleep and Pain Diaries - Medication Consumption6 weeks

    Sleep and pain medication consumption

  • Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency6 weeks

    Objective sleep onset latency (time to fall asleep)

  • Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset6 weeks

    Objective time awake after sleep onset

  • Objective Daily Sleep Actiwatch-2 - Total Sleep Time6 weeks

    Objective total sleep time

  • Objective Daily Sleep Actiwatch-2 - Sleep Efficiency6 weeks

    Objective sleep efficiency

  • Insomnia Severity Index6 weeks

    Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity