Actively Recruiting
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
Led by University of Virginia · Updated on 2024-05-08
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) to improve sleep and cognitive health in older adults with mild cognitive impairment and insomnia. This randomized controlled trial compares the CBT-I intervention to a patient education website, studying effects on sleep quality, daytime fatigue, quality of life, mood, and cognitive functions such as memory and attention. Participants are recruited online and must meet criteria for mild cognitive impairment and insomnia symptoms. Participants are randomly assigned to either the SHUTi OASIS online CBT-I program or a patient education website. The SHUTi program delivers tailored, interactive sleep therapy over 9 weeks, with new content released weekly and daily sleep diaries completed. The education group receives information about insomnia and CBT strategies all at once without tailoring. After the 9-week intervention, participants retain access to their assigned program for the study duration. Participants complete online cognitive tests, questionnaires, and sleep diaries at baseline, 9 weeks, then at 6, 12, 18, and 24 months. These assessments measure insomnia severity, sleep patterns, fatigue, quality of life, mood, and cognitive performance. The primary outcome is the Insomnia Severity Index, with additional measures including wake after sleep onset and sleep efficiency. The study lasts two years, with ongoing access to interventions and repeated assessments to track long-term effects.
CONDITIONS
Brief Title
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 65 years or older
- Able to speak and read English and a US resident
- Access to an Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study
- Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
- Sleep disturbance or daytime fatigue causing significant distress or impairment over the past three months
- Cognitive impairment confirmed through study assessment
- Stable medication regimen unless medication is known to cause insomnia
You will not qualify if you...
- Current psychological treatment for insomnia
- Started psychological or psychiatric treatment within the past three months
- Current diagnosis of Huntington's or Parkinson's disease
- Current treatment for hyperthyroidism
- Currently undergoing chemotherapy
- Asthma or respiratory concerns with night treatment
- Chronic pain treated with opioids
- Not recovered from a brain tumor, injury, or infection
- Epilepsy without stable treatment for at least 3 months
- Irregular sleep schedule
- Use of stimulating medications after 5pm or taken for less than 3 months
- Psychotic or bipolar disorder
- Moderate to high risk of suicide
- Alcohol or drug abuse within the past year
- Other untreated sleep disorders such as obstructive sleep apnea
- Severe depression as screened by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online)
Duration - 9 weeks
Participants receive either an Internet-based cognitive behavioral therapy for insomnia (CBT-I) intervention delivered over 9 weeks or access to a patient education website about insomnia.
Daily interactions with the online program and daily sleep diaries throughout the intervention period
Duration - Up to 24 months
Participants complete assessments of sleep and cognitive function at multiple time points after the intervention and continue to have access to their assigned online program.
Assessments at 9 weeks, 6 months, 12 months, 18 months, and 24 months (online)
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
M
Meghan K Mattos, PhD, RN, CNL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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