Predictors of Response to Insomnia Treatments for Gulf War Veterans

Completed · Not applicable

Conditions studied: Insomnia

In brief

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).

Key facts

Study ID

NCT03208049

Run by

VA Office of Research and Development

People needed

50

Starts

2017-08-01

Expected to finish

2023-05-21

Last updated by the study team

2026-01-26

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 risk if they have endorsement of either of the following on the C-SSRS:
• A positive endorsement, relative to the past 30 days, in the "Suicide Thoughts" section of item #4 (Have you had these thoughts and had some intention of acting on them) or item #5 (Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?
• A positive endorsement, relative to the past 90 days, in the "Suicide Behavior" section of item #6 (Have you ever done anything, started to do anything, or prepared to do anything to end your life?)
• Current or lifetime history of a psychiatric disorder with primary psychotic features
• Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation
• Current exposure to trauma, or exposure to trauma in the past 3 months
• Current or within the past 30 days: drug abuse or dependence (except nicotine)
• Current or expected cognitive behavior therapy for another condition (e.g.,: depression)
• Excessive alcohol consumption of >14 drinks per week or > 4 drinks per occasion
• Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment
• Montreal Cognitive Assessment (MOCA) < 20 or Montreal Cognitive Assessment Blind (MOCA-Blind) < 15
• Medical
• Acute or unstable chronic illness, including but not limited to:
• Uncontrolled thyroid disease
• Kidney disease
• Prostate or bladder conditions causing excessively frequent urination (> 3 times per night)
• Medically unstable congestive heart failure

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
• East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ — East Orange, New Jersey, United States

Full record on ClinicalTrials.gov

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