Sleep-SMART for Veterans

Study Overview
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Brief Summary
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Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.

Detailed Description
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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. 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. The 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.

Official Title
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Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study

Conditions
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Insomnia, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Sleep-SMART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans ages 60 or older who are competent to provide informed consent Chart diagnosis of MCI based on previously published criteria 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 Exclusion Criteria: Sleep disorders other than insomnia as determined by medical chart review and clinical interview History of a neurological disorder, dementia, or moderate to severe TBI Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder Suicidality more than low risk as assessed by the Columbia Suicide Severity Rating Scale

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators will develop and pilot test a modified CBT-I treatment that incorporates technology, user-centered design principles, and CogSMART strategies to improve sleep and rehabilitation outcomes for Veterans with co-occurring insomnia and MCI. The investigators will assess the feasibility and acceptability of Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), which will seamlessly incorporate select CogSMART cognitive strategies within a standard 6-session 50-minute CBT-I treatment protocol. Sleep-SMART will focus on enhancing CBT-I by providing supportive cognitive strategies designed to boost treatment learning and adherence.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep-SMART<br>Sleep-SMART intervention | Behavioral: Sleep-SMART<br>* Sleep-SMART will be a treatment for insomnia that will follow the standard 6 session 50-minute CBT-I format and will deliver CBT-I treatment along with training in select CogSMART strategies to enhance intervention learning and adherence. It will be delivered via video-based telehealth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention Measure (FIM) | Rating scale assessing intervention feasibility; minimum score is 4, maximum score is 20; higher scores indicating better/higher levels of feasibility. | Immediately after the intervention | 
| Client Satisfaction Questionnaire (CSQ-8) | Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. | Immediately after the intervention | 
| Telehealth Usability Questionnaire (TUQ) | Scale to assess the usability of telehealth to deliver the intervention. Responses are interpreted qualitatively. | Immediately after the intervention | 
| Acceptability of Intervention Measure (AIM) | Rating scale assessing intervention acceptability; scores range from 4-20 with higher scores indicating higher levels of acceptability. | Immediately after the intervention | 
| Intervention Appropriateness Measure (IAM) | Rating scale assessing intervention appropriateness; scores range from 4-20 with higher scores indicating higher levels of appropriateness. | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability. | Immediately before and immediately after the intervention | 
| Independent Living Skills Survey (ILSS) | Self-report scale assessing independent living skills; standardized scores ranging from 20 to 39 suggest maximum (full-time) supervision for daily living, scores from 40 to 49 suggest moderate supervision, and scores from 50 to 63 suggest minimum supervision, or independent living. | Immediately before and immediately after the intervention | 
| Quality of Life Inventory (QOLI) | Self-report scale assessing quality of life. Higher scores indicating better quality of life/satisfaction. | Immediately before and immediately after the intervention | 
| Quality of Life in Neurological Disorders (Neuro-QOL) cognition scale | Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. For example, for an 8-item form that includes items with 5 response options ranging from 1 to 5, the lowest possible raw score is 8 (8 x 1) ; the highest possible raw score is 40 (8 x 5). Conversion tables are used to translate the total raw score into an IRT-based T score for each participant. A higher Neuro-QoL T-score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale. | Immediately before and immediately after the intervention | 
| Everyday Cognition Scale (ECoG) | Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. The final score is an average of the individual scores for each item answered out of the 39 items in the questionnaire and ranges from 1 to 4. | Immediately before and immediately after the intervention | 
| Insomnia Severity Index (ISI) | Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia. | Immediately before the intervention, weekly during the intervention, and immediately after the intervention | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-report scale assessing sleep quality over a 1-month interval. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5or greater indicates a poor sleeper | Immediately before and immediately after the intervention | 
| Hopkins Verbal Learning Test-Revised | Performance based measure of verbal list learning and memory. Higher scores indicate better performance. | Immediately before and immediately after the intervention | 
| Brief Visuospatial Memory Test-Revised | Performance based measure of Visual design learning and memory. Scores are based on individual performance. Higher scores indicate better performance/memory. | Immediately before and immediately after the intervention | 
| Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span | Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance. | Immediately before and immediately after the intervention | 
| Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test | Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance. | Immediately before and immediately after the intervention | 
| Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test | Performance based measures of executive function. Scores are based on the number of words generated for the verbal fluency task. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance. | Immediately before and immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability