SleepSMART for Veterans With MCI and Insomnia

Completed · Not applicable

Conditions studied: Insomnia, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT05016960

Run by

VA Office of Research and Development

People needed

30

Starts

2022-01-04

Expected to finish

2023-12-31

Last updated by the study team

2026-01-21

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

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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