Predictors of Response to Insomnia Treatments for Gulf War Veterans (NCT03208049) | Clinical Trial Compass
CompletedNot Applicable
Predictors of Response to Insomnia Treatments for Gulf War Veterans
United States50 participantsStarted 2017-08-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and effectiveness of Behavioral Therapy (BT) and Cognitive Therapy (CT) in Gulf War Veterans with insomnia. The Primary Outcome measure is the Insomnia Severity Index (ISI).
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Male or female Gulf War Veterans of any racial or ethnic group
* Independent Living (not in nursing home or VA Extended Care facility)
* Subjective complaint of insomnia on the Insomnia Severity Index (ISI) greater than or equal to 10
* Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below
* Stable (3 weeks) CNS active medications that could significantly impact sleep or alertness
* Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable
* Access to a device with video capabilities and ability to have the video on during study visits.
Exclusion Criteria:
Sleep-Related
* Excessive caffeine consumption (4 or more cups of coffee per day) and unable to reduce to 3 cups or less a day before lunch a day for 3 weeks prior to treatment
* Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea)
* Those with responses suggestive of high risk for sleep apnea will be referred to Pulmonary Medicine for standard clinical screening including polysomnography
* Those where apnea is primarily responsible for their sleep complaints will be excluded
* Subjects working a rotating shift or an unconventional daytime shift (ending after 1830h) will be ineligible
Neuropsychiatric
* Hamilton Depression Scale (HDRS 24) and classified as high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past month
* Individuals are considered high…