Clinical Research Directory
Browse clinical research sites, groups, and studies.
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
Sponsor: VA Office of Research and Development
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.
Official title: SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-07-01
Completion Date
2030-03-31
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States