SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment

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.

NCT Number	NCT07397182
Lead Sponsor	VA Office of Research and Development
Conditions	Insomnia, Mild Cognitive Impairment
Enrollment	150 participants
Start Date	2026-11-02
Primary Completion	2029-11-01 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-23