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Not Yet Recruiting NCT05724498

Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans

Conditions: Insomnia

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 250
Sponsor: VA Office of Research and Development

Location: United States

Summary

Insomnia is a common condition in Veterans, with prevalence rates as high as 53% among treatment-seeking Veterans. Chronic untreated insomnia is associated with increased risk for functional impairment, psychiatric illness, suicidal ideation, unhealthy lifestyles, and decreased quality of life. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for insomnia. Despite its proven efficacy, CBT-I is not always readily provided and/or accessible to Veterans. To address these limitations, behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I. Although these modifications show promise for advancing care and access, studies comparing brief treatments to standard CBT-I have yet to be performed. This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep, functional, and psychiatric outcomes in Veterans with insomnia.

Eligibility Criteria

Inclusion Criteria:A diagnosis of insomnia as classified by the (a) Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) which includes daytime impairment in functioning for > 3 months and occurring at least 3 nights per week and (b) subjective sleep disturbance defined by an Insomnia Severity Index (ISI) score >7 at intakeMeets current DSM 5 criteria for a comorbid mental health disorderNo formal therapist guided treatment with brief or standard Cognitive-Behavioral Therapy for Insomnia within the past 2 yearson stable medication regimen for at least 4 weeks prior to enrollment in study.Exclusion Criteria:History of a acute or unstable neurological disorder(s), dementia, or premorbid IQ <70Schizophrenia, psychotic disorder, and/or bipolar disorderSuicidality more than "medium risk" as determined by the VA Comprehensive Suicide Risk AssessmentSleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea, periodic limb movements, narcolepsy, and/or circadian-based sleep disruptions)alcohol and/or substance use disorder for 90 days prior to intake, but past history of alcohol and/or substance use is not exclusionary.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05724498). StuddyBuddy aggregates publicly available trial information.