Cognitive Behavioral Therapy for Insomnia for Gulf War Illness (NCT02782780) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
United States165 participantsStarted 2016-10-24
Plain-language summary
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate whether a type of behavioral sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI. CBTi is a multicomponent treatment where patients learn about sleep and factors affecting sleep as well as how to alter habits that may impair or even prevent sleep. The investigators hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may also help to alleviate their other non-sleep symptoms of GWI.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Deployed to the Gulf Theater of operations, as defined by 38 CFR 3.317 in the years 1990-1991, in accordance with the inclusion/exclusion criteria set forth in the federal definition of Gulf War Illness as used for the Gulf War Registry.
* This will be confirmed through VA records or by asking veterans to provide a copy of their DD214.
* Have Gulf War Illness (GWI) according to the Kansas case definition.
* GWI symptom will be assessed with the Kansas Gulf War Military History and Health Questionnaire.
* Have an Insomnia Severity Index score greater than or equal to 14.
Exclusion Criteria:
* Have conditions or substances that may be associated with comorbid insomnia independent of GWI status, including:
* a lifetime history of any psychiatric disorder with psychotic features
* bipolar disorder
* panic disorder
* obsessive-compulsive disorder
* alcohol or substance dependence
* a history of alcohol or substance abuse within the past year
* Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months.
* Pregnancy (because insomnia will worsen after 8 weeks).
* Prominent suicidal or homicidal ideation.
* History of sleep restriction therapy or cognitive restructuring therapies of beliefs related to sleep.
* Subjects concurrently enrolled in another clinical trial.
* Veterans who work night shifts or have extreme morning or evening tendencies as described below will be excluded in order to avo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gulf War Illness Symptom Severity Index
Timeframe: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
2
Insomnia Severity Index (ISI)
Timeframe: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation