New online therapy aims to help dementia caregivers get better sleep

NCT ID NCT04632628

Symptom relief Sponsor: University of South Florida Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a web-based version of cognitive behavioral therapy for insomnia (CBT-I) in 60 family caregivers of people with dementia. Caregivers will complete four online sessions focused on sleep habits, relaxation, and changing unhelpful thoughts. The goal is to improve sleep, mood, and overall well-being, making treatment more accessible for busy caregivers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Web-based cognitive behavioral therapy for insomnia (CBT-I)
What this could lead to: If it works, this could provide an accessible, at-home treatment to help dementia caregivers sleep better and feel less stressed.
What could go wrong: This is a small, early-stage study with only 60 participants, so results may not apply to all caregivers. The web-based format may not work as well as in-person therapy for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

CAREGIVER Inclusion Criteria: * 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. 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: * 18+ yrs * 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

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Conditions

The condition(s) this trial relates to.

dementia insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia Insomnia chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New online therapy aims to help dementia caregivers get better sleep

What the study statuses mean