Can talking therapies help gulf war vets sleep better?
NCT ID NCT03208049
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether two types of talk therapy—Behavioral Therapy and Cognitive Therapy—can help Gulf War Veterans who have trouble sleeping. Fifty veterans took part, and their sleep problems were measured using a standard questionnaire. The goal was to see which therapy works best and for whom.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
50 people
The number who actually took part.
- Started
-
Aug 2017
- Finished
-
May 2023
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 * Angina * Other severe cardiac illness as defined by treatment regimen changes in the prior 3 months * Stroke with serious sequelae * Cancer if \< 1 year since end of treatment * Asthma * Emphysema * Other severe respiratory diseases uncontrolled with medications * Neurological disorders such as Alzheimer's disease, Parkinson's disease, and/or unstable epilepsy as defined by treatment regimen changes in the prior 3 months * Unstable adult-onset diabetes will be excluded
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Insomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018, United States
-
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207, United States
-
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a sleep drug help cirrhosis patients rest and think clearer?
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Does soreness after exercise disrupt sleep more for people with insomnia?
- Can fixing insomnia help heavy drinkers cut back?
- Can a sleep therapy program help control blood sugar in older diabetes patients?