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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Insomnia Severity Index [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]

Secondary outcome measures (8)

• Wake after sleep onset (WASO) [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Sleep onset latency (SOL) [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Multidimensional Fatigue Symptoms Inventory - Short Form [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Short Form-12 Health Survey (Quality of Life) [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Match to Sample Visual Search [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Spatial Working Memory Test [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Paired Associates Learning [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]
• Sleep Efficiency [Time frame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Virginia — Charlottesville

Identifiers

NCT: NCT05565833 · IRB-HSR #220077

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗