loading
loading
NIH grant 1I01RD000596-01A2: SleepSMART for Veterans with Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
Institute: {'code': 'VA', 'abbreviation': 'VA', 'name': 'Veterans Affairs', 'admin_org_id': '12500964', 'admin_funding_url': ''}. PI: ERIN ALMKLOV. Award: $.
Start: 2026-10-01T00:00:00.
Background: 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. Our 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. Significance: Insomnia commonly co-occurs with MCI and is
associated with increased risk for dementia, other morbidity, premature mortality, disability, reduced quality of
life, and impaired functioning across multiple life areas. Veterans are a particularly vulnerable population as they
have much higher rates of insomnia compared to civilians as well as other risk factors for cognitive decline and
disability (e.g., TBI and PTSD). Given the potentially devastating consequences of poor sleep, effective treatment
for insomnia is critical for maintaining Veteran health and functioning. Aims: In a randomized controlled trial, the
proposed investigation aims to compare the effectiveness of SleepSMART to standard CBT-I on 1) insomnia
symptoms, 2) subjective and objective cognitive functioning, daily functioning, disability, and quality of life, and
3) measures of treatment acceptability, appropriateness, adherence, and satisfaction. Methodology: We will
enroll 150 Veterans aged 60 or older with insomnia and MCI. We will use Hierarchical Linear Modeling to test
specific intervention effects (SleepSMART vs. CBT-I) on target outcomes. Following a comprehensive pre-
treatment assessment, enrolled Veterans will be randomized to one of two treatment groups (6 sessions of
SleepSMART or 6 sessions of CBT-I). Following completion of the intervention, Veterans will complete a post-
treatment assessment and a three-month follow-up assessment. At each of the three assessment timepoints,
Veterans will be assessed on well-validated measures of sleep disorders and symptomatology, functional
status/disability, and quality of life, as well as subjective and objective cognitive functioning. Next Steps:
Findings from this investigation will inform best treatment practices for Veterans experiencing co-occurring MCI
and insomnia, and ensure these Veterans are receiving the highest quality care possible. Based on the results,
we will work with the CBT-I rollout group to disseminate and train therapists to deliver SleepSMART. Future trials
will focus on larger multi-site trials, evaluating SleepSMART in other cognitively impaired populations, and on
dissemination and implementation efforts.document fetched 2026-10-24 02:46