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NCT07397182
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
Conditions: Insomnia, Mild Cognitive Impairment
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: VA Office of Research and Development
Location: VA San Diego Healthcare System, San Diego, CA San Diego California
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT07397182). StuddyBuddy aggregates publicly available trial information.