Clinical trial NCT05565833: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Insomnia
Cognitive Dysfunction
Mild Cognitive Impairment
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Alzheimer Disease
Keywords: Insomnia
Alzheimer's disease
Mild cognitive impairment
Cognitive behavioral therapy
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Secondary outcomes:
measure: Wake after sleep onset (WASO)
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Sleep onset latency (SOL)
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Multidimensional Fatigue Symptoms Inventory - Short Form
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Short Form-12 Health Survey (Quality of Life)
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Match to Sample Visual Search
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Spatial Working Memory Test
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Paired Associates Learning
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Sleep Efficiency
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
measure: Insomnia Knowledge Scale
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Falls frequency
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Self-Efficacy Scale- Insomnia-Specific
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
measure: Lawson's Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Meghan K Mattos, PhD, RN, CNL
role: PRINCIPAL_INVESTIGATOR
References: