Cognitive Behavioral Therapy for Insomnia for Gulf War Illness

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.

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 avoid the impact of circadian factors on
evaluating insomnia.