SleepSMART for Veterans With MCI and Insomnia (SleepSMART)

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Sleep-SMART

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep-SMART; Sleep-SMART intervention	Behavioral: Sleep-SMART; Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Mean scores were calculated at post-treatment. No statistical analyses were performed.	At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Telehealth Usability Questionnaire (TUQ)	Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.	At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Acceptability of Intervention Measure (AIM)	Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.	At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Intervention Appropriateness Measure (IAM)	Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.	At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

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 "5"or 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

Other 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.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
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. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
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. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Insomnia Severity Index (ISI)	Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)	Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)	Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score	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 and range from <3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)	Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to >21, with higher scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)	Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)	Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)	Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)	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 presented in seconds with lower scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)	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 presented in seconds with lower scores indicating better performance.	At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Erin Almklov, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Veterans; Mild Cognitive Impairment; Insomnia; Acceptability; Behavioral Sleep treatment; CBT for Insomnia; CogSMART
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: D3721-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No