RightFit
RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete a pre-assessment battery, which consists of an online cognitive test, an online questionnaire, and two weeks of sleep diaries."
  • "At the start of week nine, all participants will be instructed to complete the post-assessment battery (cognitive test, questionnaires, and diaries)."
  • "This same assessment (cognitive test, questionnaires, and diaries) will be completed at 6, 12, 18, and 24 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (1)

VA