Internet-based therapy for insomnia and cognitive health
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
This study is testing whether an online therapy for insomnia can help improve sleep and thinking skills in people with mild cognitive impairment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05565833 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effects of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) on sleep and cognitive health in individuals with mild cognitive impairment. Participants with insomnia will be recruited and randomized to receive either the CBT-I intervention or patient education. The study will assess various outcomes, including sleep quality, daytime functioning, and cognitive status through online assessments and sleep diaries over a period of 24 months. The goal is to determine the effectiveness of the CBT-I intervention in improving both sleep and cognitive function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older who experience insomnia and have mild cognitive impairment.
Not a fit: Patients currently undergoing psychological treatment for insomnia or those with certain neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and cognitive health in older adults with mild cognitive impairment.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapy for insomnia can be effective, suggesting potential success for this Internet-based approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 65 years of age. * Able to speak and read English, and is a US resident. * Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study. * Sleep-onset insomnia and/or sleep maintenance insomnia symptoms * The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months. * Cognitive impairment through study assessment. * Stable medication regimen unless medication is known to cause insomnia Exclusion Criteria: * Current psychological treatment for insomnia * Initiation of 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 * Presence of 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 (e.g., obstructive sleep apnea) * Study screen for severe depression
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Meghan K Mattos, PhD, RN, CNL — University of Virginia
- Study coordinator: Meghan K Mattos, PhD, RN, CNL
- Email: ms2bv@virginia.edu
- Phone: 434-243-3936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.