SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment

NCT07397182 | Not Yet Recruiting

• 2 other identifiers: RRD4-013-25M1I01RD000596-01A2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.

Conditions

Insomnia; Mild Cognitive Impairment

Keywords

Veterans; Insomnia; Mild Cognitive Impairment; Sleep treatment; Cognitive functioning

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.

  Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)

Study Arms (2)

SleepSMART

EXPERIMENTAL

SleepSMART was developed as an adapted form of CBT-I specifically designed for older Veterans with insomnia and cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence.

Behavioral: SleepSMART

CBT-I

ACTIVE COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment designed to help individuals overcome chronic insomnia by addressing the underlying cognitive and behavioral factors contributing to sleep difficulties.

Behavioral: Cognitive BehavioralTherapy for Insomnia (CBT-I)

Interventions

Cognitive BehavioralTherapy for Insomnia (CBT-I) BEHAVIORAL

This manualized approach to treatment involves 6 weekly sessions and addresses the underlying causes of insomnia utilizing sleep restriction and stimulus control techniques, relaxation training, and relapse prevention. In Session 1 sleep education, goal setting, and Sleep Restriction Therapy (SRT) guidelines will be introduced. In Session 2 the Veteran's sleep diary will be reviewed, time in bed (TIB) will be modified based on SRT, and Stimulus Control (SC) instructions will be provided. Session 3 will commence with a review of the sleep diary and adjustments to TIB will be made. In this session a discussion of cognitive factors that may impact insomnia and therapy adherence will be discussed. Additionally, stress management and/or relaxation training will be introduced. In Sessions 4 and 5 sleep diaries will be reviewed, adherence to the treatment discussed, and TIB will be modified based on SRT rules. In Session 6 continued care and relapse prevention plans will be developed.

CBT-I

SleepSMART BEHAVIORAL

This treatment involves six 50-minute sessions and addresses key CBT-I components including sleep education, sleep restriction/sleep compression therapy, stimulus control techniques, cognitive therapy, relaxation training, and relapse prevention. Each session includes CogSMART cognitive strategies designed to support treatment learning and adherence.

SleepSMART

Eligibility Criteria

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

You may qualify if:

• Veterans
• chart diagnosis MCI
• 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
• stable on medications for at least 4 weeks prior to enrollment

You may not qualify if:

• presence of neurological disorders such as Parkinson's disease or seizures, dementia (based on chart diagnosis or clear evidence of dementia at the baseline neuropsychological testing using DSM5 criteria for Major Neurocognitive Disorder)
• and/or history of moderate to severe TBI (determined by medical record or self-report of \>30 minutes loss of consciousness)
• schizophrenia, psychotic disorder, and/or bipolar disorder
• untreated or poorly managed medical conditions that may impact sleep, including thyroid disease, nocturia, chronic respiratory or heart disease, or diabetes
• untreated obstructive sleep apnea and/or sleep disturbances other than insomnia
• current substance use disorder with \<30 days abstinence
• suicidality greater than mild risk as measured by the Columbia-Suicide Severity Rating Scale
• exposure to therapist directed (individual or group) CBT-I within the past year

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

Study Officials

• Erin Almklov, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Almklov, PhD

CONTACT

(858) 855-8585; erin.almklov@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two treatment conditions (SleepSMART or CBT-I).

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)