Sleep-SMART for Veterans with MCI and Insomnia: A Pilot Study

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Background: Mild cognitive impairment (MCI) is an important public health concern for aging Veterans due to the increased risk for progression to dementia and increased mortality. Insomnia is common in MCI (occurring in up to 60% of patients) and increases risk for dementia, disability, and poor quality of life. Rates of MCI and insomnia are higher among Veterans than civilians, thus aging Veterans with MCI and comorbid insomnia represent a particularly high-risk population. The gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a multi-component behavioral intervention. However, cognitive impairments experienced by individuals with MCI may limit the rate of progress in CBT-I. The use of memory support strategies can improve patient recall of therapeutic information, enhance treatment adherence, and improve treatment outcomes. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) provides compensatory strategies to improve learning, memory, attention, and executive functioning. CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive impairment. Incorporating supportive CogSMART cognitive strategies into CBT-I has the potential to improve treatment learning, adherence, and outcomes for this Veteran population. Significance: This RR&D SPiRE research project will assist us in developing and evaluating Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an innovative user-informed approach for treatment of insomnia in Veterans with MCI. Sleep-SMART is intended to provide the core components of CBT-I along with training in compensatory cognitive strategies from CogSMART to enhance intervention adherence and learning. Provision of this supportive cognitive training will assist Veterans with cognitive impairments in maintaining compliance with the CBT-I regimen, thereby leading to faster and more complete treatment benefits. Aims: Our principle aims for the investigation include: 1) developing the Sleep-SMART intervention and treatment manual; 2) assessing the feasibility and acceptability of Sleep-SMART in Veterans with MCI and insomnia; and 3) exploring the effects of Sleep-SMART on rehabilitation outcomes, quality of life, sleep, and cognitive functioning. Methodology: We propose to develop the Sleep-SMART intervention and manual over the first 6 months of the project (Phase I) using a participatory research approach guided by the Intervention Mapping Adapt framework. We will subsequently assess the feasibility and acceptability of Sleep- SMART (Phase II) by enrolling 26 Veterans ages 60 and older to receive six 50-minute weekly sessions of individual Sleep-SMART treatment via secure video-conferencing. Feasibility will be assessed through recruitment metrics, level of Veteran participation in the treatment, clinician fidelity to the treatment protocol, and evaluation of barriers to treatment implementation. Acceptability will be assessed primarily through questionnaires and other measures assessing satisfaction, acceptability, appropriateness, and adherence to the intervention. While efficacy is not our primary aim, we will collect some initial data for estimating effect sizes to assist in future power calculations. Veterans will be asked to complete specific measures of disability, independent living skills, quality of life, sleep, and cognitive functioning. Next Steps: Pilot data acquired from this investigation will be used for application(s) to conduct randomized controlled trials investigating the efficacy of Sleep-SMART in Veterans with MCI and insomnia compared to standard CBT-I or treatment as usual. The results of this investigation will also be used to inform scale-up implementation and dissemination efforts.