The purpose of this study is to determine whether a behavioral sleep treatment improves sleep and other Gulf War Illness (GWI) symptoms in Gulf War Veterans with GWI.
This study is a randomized controlled trial of a behavioral sleep treatment to improve sleep and other symptoms of Gulf War Illness (GWI) in Gulf War (GW) Veterans with GWI, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home) or telephone. The primary outcome for this study is the severity of Gulf War Illness symptom severity. Other outcomes include sleep-related functioning, insomnia symptom severity, and positive airway pressure (PAP) adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
118
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
VA Health Care System
San Francisco, California, United States
Change in 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.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
Change in 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.
Time frame: Change from baseline to 3 months after treatment ends.
Change in Positive Airway Pressure (PAP) Adherence
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured from session 1 through post-treatment.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
Positive Airway Pressure (PAP) Adherence
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured for 1 week at the follow-up 3 months after treatment ends.
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Time frame: Change from baseline to 3 months after treatment ends.
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Time frame: Change from baseline to 3 months after treatment ends.