Cognitive Behavioral Therapy for Insomnia for Gulf War Illness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gulf War Illness, Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBTi<br>CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi)<br>* CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long.<br>* Other names: CBTi;|
| No Intervention: Monitor Only<br>Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gulf War Illness Symptom Severity Index | Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms. | At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Insomnia Severity Index (ISI) | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia. This outcome will be measured at 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale (FSS) | The FSS is a 9-item questionnaire reflecting the consequences of fatigue. It gives a single score (range 0-7, high scores represent high levels of fatigue). A score of 4 has been described as the cutoff for clinical fatigue. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Brief Pain Inventory (BPI) - Pain Interference | The BPI is a 17-item self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. The BPI measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Brief Pain Inventory (BPI) - Pain Severity | The BPI is a 17-item self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. The BPI measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Multiple Abilities Self-Report Questionnaire (MASQ) | The MASQ is a 38-item self-report measure of cognitive function compared to same age peers across 5 domains (i.e., verbal memory, attention, language, visual memory, visuo-perceptual ability). Score range: 38-190. Higher scores = greater cognitive dysfunction. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Hospital Anxiety and Depression Scale (HADS), Anxiety | The HADS will be used to assess anxiety and depressive symptoms. The HADS is widely used in community settings and in primary care and not just in hospitals. The range for HADS-anxiety measure is 0-21. Higher scores = more anxiety. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Hospital Anxiety and Depression Scale (HADS), Depression | The HADS will be used to assess anxiety and depressive symptoms. The HADS is widely used in community settings and in primary care and not just in hospitals. The range for HADS-depression measure is 0-21. Higher scores = more anxiety. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a self-report measure that provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sedative-hypnotics, and daytime energy. This index is widely used and has been validated by polysomnography. The score range for the PSQI is 0 to 21, with the higher scores indicating worse sleep quality.This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Sleep Efficiency (SE) | Sleep Efficiency, as determined by self-reported sleep diary, is the total sleep time (TST) divided by the time in bed, multiplied by 100. Good sleepers have high sleep efficiency because they are asleep the majority of time they spend in bed. Insomniacs tend to have low sleep efficiency because they spend a lot of time awake while they are in bed (tossing and turning). This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 
| Minutes of Wake After Sleep Onset (WASO) | Wake After Sleep Onset is the amount of time that a person is awake time during the night, as recorded in a self-report sleep diary. Insomniacs tend to have greater WASO than good sleepers because they wake up a lot in the middle of the might. This outcome will be measured at baseline, post-treatment in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline and after 8 weeks of study participation in all subjects; in subjects randomized to CBTi, 6 months after study participation | 
| Sleep Latency (SL) | Sleep latency (SL) is the amount of time that it takes someone to fall asleep. Participants will be asked to estimate this time in their sleep diaries. Good sleepers tend to have low sleep latencies because they can fall asleep quickly. Insomniacs tend to have longer sleep latencies because it takes them a long time to fall asleep. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi. | Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, insomnia disorder, Gulf War Illness, Chronic Multisymptom Illness