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临床试验/NCT07397182
NCT07397182尚未招募不适用

SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.

详细描述

With increasing age, adults report greater frequency of insomnia symptoms, including difficulty falling and staying asleep, waking too early, and associated impairments in daytime functioning and quality of life. Veterans are particularly vulnerable to insomnia, with rates double and even triple those of civilian populations. When left untreated, chronic insomnia may contribute to increased risk for cognitive decline (e.g., Alzheimer's disease) and can lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life. CBT-I is the first-line treatment for insomnia, but factors like poor adherence and poor recall for CBT-I content can diminish its impact for certain populations. Specifically, the cognitive impairments experienced by individuals with Mild Cognitive Impairment (MCI) may limit the adherence and rate of progress in CBT-I. Therefore, it is critical to ensure that vulnerable populations, such as older Veterans with MCI, can fully benefit from sleep treatment. The study team developed SleepSMART (Sleep Symptom Management and Rehabilitation Therapy) to help cognitively impaired Veterans learn and adhere to the CBT-I regimen, thereby leading to faster and more complete sleep treatment benefits. Based on the results of a recent pilot investigation, SleepSMART demonstrated preliminary efficacy as a modified form of CBT-I treatment that is uniquely tailored to aging Veterans with MCI. This investigation will build on previous research by conducting a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I, in 150 Veterans age 60+ with insomnia and MCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors will be blind to treatment condition

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chart diagnosis MCI
  • DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score >7 at baseline
  • ability to understand, speak, and read English with acceptable visual and auditory acuity
  • stable on medications for at least 4 weeks prior to enrollment

排除标准

  • presence of neurological disorders such as Parkinson's disease or seizures, dementia (based on chart diagnosis or clear evidence of dementia at the baseline neuropsychological testing using DSM5 criteria for Major Neurocognitive Disorder)
  • and/or history of moderate to severe TBI (determined by medical record or self-report of >30 minutes loss of consciousness)
  • schizophrenia, psychotic disorder, and/or bipolar disorder
  • untreated or poorly managed medical conditions that may impact sleep, including thyroid disease, nocturia, chronic respiratory or heart disease, or diabetes
  • untreated obstructive sleep apnea and/or sleep disturbances other than insomnia
  • current substance use disorder with <30 days abstinence
  • suicidality greater than mild risk as measured by the Columbia-Suicide Severity Rating Scale
  • exposure to therapist directed (individual or group) CBT-I within the past year

研究组 & 干预措施

SleepSMART

Experimental

SleepSMART was developed as an adapted form of CBT-I specifically designed for older Veterans with insomnia and cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence.

干预措施: SleepSMART (Behavioral)

CBT-I

Active Comparator

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment designed to help individuals overcome chronic insomnia by addressing the underlying cognitive and behavioral factors contributing to sleep difficulties.

干预措施: Cognitive BehavioralTherapy for Insomnia (CBT-I) (Behavioral)

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)

Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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