SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cognitive BehavioralTherapy for Insomnia (CBT-I)
- SleepSMART
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov