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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Другое Patient Education
  An educational website containing information on insomnia

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Virginia — Charlottesville

Идентификаторы

NCT: NCT05565833 · IRB-HSR #220077

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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