Internet-Based Cognitive Behavioral Therapy for Insomnia and Mild Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an online therapy to help people with insomnia and mild cognitive issues. The therapy aims to improve sleep by changing negative thoughts and behaviors related to sleep. Researchers will see if better sleep also helps with cognitive health. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to be effective in improving sleep quality and reducing insomnia symptoms through various delivery methods, including online platforms.
Will I have to stop taking my current medications?
The trial requires that participants have a stable medication regimen unless the medication is known to cause insomnia. If your current medication is stable and not causing insomnia, you likely won't need to stop taking it.
Is Internet-Based Cognitive Behavioral Therapy for Insomnia safe for humans?
How is the SHUTi OASIS treatment different from other treatments for insomnia and mild cognitive impairment?
What data supports the effectiveness of the treatment Internet-Based Cognitive Behavioral Therapy for Insomnia and Mild Cognitive Impairment?
Research shows that Internet-based cognitive-behavioral therapy for insomnia (CBT-I), like SHUTi, is effective in improving sleep quality and reducing insomnia symptoms. Studies have found it to be convenient, understandable, and useful, with most users experiencing improved sleep and quality of life.1351011
Who Is on the Research Team?
Meghan K Mattos, PhD, RN, CNL
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for US residents aged 65 or older with mild cognitive impairment and insomnia, who can read English and have internet access. They must be willing to follow the study procedures for its duration. Excluded are those with irregular sleep schedules, substance abuse issues, severe depression risk, recent psychological treatments, certain medical conditions like untreated sleep disorders or epilepsy without stable treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-assessment
Participants complete an online cognitive test, an online questionnaire, and two weeks of sleep diaries
Treatment
Participants receive either the Internet-based CBT-I intervention or patient education for 9 weeks
Post-assessment
Participants complete the post-assessment battery including cognitive test, questionnaires, and diaries
Follow-up
Participants are monitored for changes in sleep, cognitive status, and other health measures at 6, 12, 18, and 24 months
What Are the Treatments Tested in This Trial?
Interventions
- Patient Education
- SHUTi OASIS
SHUTi OASIS is already approved in United States for the following indications:
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Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor