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Can talking therapies help gulf war vets sleep better?

NCT ID NCT03208049

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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