NCT05565833

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

Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 patient education (PE) control condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables (reduced overall insomnia severity and wake after sleep onset), daytime variables (reduced levels of fatigue, improved quality of life, and improved mood), and cognitive status (memory, attention/psychomotor speed, and executive functioning domains). Participants will complete a pre-assessment battery, which consists of an online cognitive test, an online questionnaire, and two weeks of sleep diaries. Once complete, participants will be randomized to either the Internet-based PE or CBT-I intervention. At the start of week nine, all participants will be instructed to complete the post-assessment battery (cognitive test, questionnaires, and diaries). After completing the post-assessment, participants will have continued access to their assigned online program throughout the study duration. This same assessment (cognitive test, questionnaires, and diaries) will be completed at 6, 12, 18, and 24 months.

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

Type	Name	Description
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

Timeline

• Start date: 2023-02-27
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2022-10-04
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States