Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
NCT05565833 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2024-05-08
Summary
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.
Conditions
- Insomnia
- Cognitive Dysfunction
- Mild Cognitive Impairment
- Sleep Initiation and Maintenance Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Nervous System Diseases
- Alzheimer Disease
Interventions
- BEHAVIORAL
-
SHUTi OASIS
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program
- OTHER
-
Patient Education
An educational website containing information on insomnia
Sponsors & Collaborators
-
University of Virginia
lead OTHER
Principal Investigators
-
Meghan K Mattos, PhD, RN, CNL · University of Virginia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-27
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
Countries
- United States
Study Locations
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