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SleepSMART for Veterans With MCI and Insomnia

NCT05016960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-21

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Erin Almklov, PhD · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05016960 on ClinicalTrials.gov