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Summary

at San Francisco, California
study started
estimated completion:
Linda L. Chao

Description

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.

Official Title

Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans With Gulf War Illness

Details

Insomnia is common among Veterans with Gulf War Illness (GWI). Moreover, untreated insomnia is associated with significant medical and psychiatric morbidity. Cognitive Behavioral Therapy for Insomnia (CBTi) is a multicomponent treatment that seeks not only to teach patients about sleep and factors affecting sleep (e.g., circadian rhythm, age, social and work schedule) but the therapist will also to work with the patient toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity.

Because many Veterans with GWI suffer from a profound loss of physical and functional status that may prevent them from participating in treatments that require regular clinic visits, the proposed study will deliver CBTi by telephone to extend this effective form of behavioral sleep medicine to Veterans who have chronic illnesses and disabilities and/or who live in rural areas with limited access to trained CBTi providers. Recent studies suggest that telephone-delivered CBTi is as effective as CBTi delivered in-person.

The proposed trial will examine the efficacy of telephone-delivered CBTi for alleviating sleep and non-sleep GWI symptoms in a two-arm randomized controlled trial. Veterans who have GWI and persistent insomnia disorder will be randomized to a group that will receive CBTi right away or to a group that will receive treatment-as-usual (i.e., the control group). Veterans randomized to the control group will have the option of receiving telephone-delivered CBTi upon completion of post-treatment assessments. The primary outcomes will be effect sizes base on within-group comparisons of pre-to-post-treatment change and maintenance of treatment effects at 6 months in the CBTi group.

Keywords

Gulf War Illness Insomnia insomnia disorder Chronic Multisymptom Illness

Eligibility

You can join if…

  • Deployed to the Gulf Theater of operations, as defined by 38 CFR 3.317 in the years 1990-1991, in accordance with the inclusion/

You CAN'T join if...

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 avoid the impact of circadian factors on evaluating insomnia.

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT02782780
Phase
Phase 2
Lead Scientist
Linda L. Chao
Study Type
Interventional
Last Updated
May 1, 2017
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