N/A
Completed N=30
SleepSMART for Veterans With MCI and Insomnia
Source: ClinicalTrials.gov NCT05016960 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Apr 2025
Primary outcomePrimary: Client Satisfaction Questionnaire (CSQ-8) — 29.43 score on a scale
Summary
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Satisfaction Questionnaire (CSQ-8) |
29.43 | — |
| PRIMARY Telehealth Usability Questionnaire (TUQ) |
5.92 | — |
| PRIMARY Acceptability of Intervention Measure (AIM) |
4.39 | — |
| PRIMARY Intervention Appropriateness Measure (IAM) |
4.41 | — |
Eligibility Criteria
Inclusion Criteria
- Veterans ages 60 or older who are competent to provide informed consent
- Chart diagnosis of MCI based on previously published criteria
- 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
Exclusion Criteria
- Sleep disorders other than insomnia as determined by medical chart review and clinical interview
- History of a neurological disorder, dementia, or moderate to severe TBI
- Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments
- Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder
- Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale
Data sourced from ClinicalTrials.gov (NCT05016960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.