SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment

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

Interventions

BEHAVIORAL

Cognitive BehavioralTherapy for Insomnia (CBT-I)

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.

BEHAVIORAL

SleepSMART

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.

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

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-11-01

Completion

2030-03-31

Countries

• United States

Study Locations