SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
Starting soon · Not applicable
Conditions studied: Insomnia, Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT07397182
- Run by
- VA Office of Research and Development
- People needed
- 150
- Starts
- 2026-11-02
- Expected to finish
- 2030-03-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
Full record on ClinicalTrials.gov
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