SleepSMART for Veterans With MCI and Insomnia

NCT05016960 | Completed Results

• 1 other identifier: D3721-P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Mild Cognitive Impairment

Keywords

Insomnia; Mild Cognitive Impairment; Veterans; Behavioral Sleep treatment; CBT for Insomnia; CogSMART; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (4)

• 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.

Other Outcomes (14)

• WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

  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

  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)

  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.

Study Arms (1)

Sleep-SMART

EXPERIMENTAL

Sleep-SMART intervention

Behavioral: Sleep-SMART

Interventions

Sleep-SMART BEHAVIORAL

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.

Sleep-SMART

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Results Point of Contact

• Title: Dr. Erin Almklov
• Organization: VA San Diego Healthcare System

erin.almklov@va.gov

858-552-8585

Study Officials

• Erin Almklov, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 23, 2021
• Study Start: January 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 21, 2026
• Results First Posted: April 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)