Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05565833
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alzheimer Disease
  • Cognitive Dysfunction
  • Dyssomnias
  • Insomnia
  • Mild Cognitive Impairment
  • Nervous System Diseases
  • Sleep Disorders, Intrinsic
  • Sleep Initiation and Maintenance Disorders
  • Sleep Wake Disorders

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHUTi OASIS — BEHAVIORAL
    Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
  • Patient Education — OTHER
    An educational website containing information on insomnia

Study Details

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

Key Dates

Start date
Feb 27, 2023
Status verified
May 2024
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHUTi OASIS
    Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) for Older Adult Sufferers of Insomnia and Sleeplessness (OASIS) online intervention optimized for older adults. CBTi will be delivered online and metered out over time with each new core becoming available one week after the completion of the previous core. The intervention period is 9 weeks. They will spend 1-2 hours during the intervention period completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention targeting issues specific to older adults. As users progress through the intervention, they will receive automated, tailored instructions on how to improve their sleep.
  • Placebo Comparator: Patient Education Website
    Participants will be assigned to a relevant patient education website. It will include information about insomnia symptoms, diagnosis, prognosis, and information about CBT strategies for the older adult. Unlike SHUTi, the content will not be tailored and will be presented all at once.

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Meghan Mattos, PhD
[email protected]
434-243-3936

Find similar trials in Charlottesville, VA

By condition
Alzheimer's diseaseInsomnia
By specialty
NeurologyDementia careBrain disordersGeriatricsMental healthSleep medicine
By research site
University of Virginia· Charlottesville, VA

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