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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP - GW200046 | Other Grant/Funding Number | CDMRP |
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| Name | Class |
|---|---|
| San Francisco VA Health Care System | FED |
| United States Department of Defense | FED |
| CDMRP | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | 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 (CBT-I). |
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| Sleep Education (SE) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apnea and Insomnia Relief (AIR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 1 week post-treatment (after 6 weeks). |
| Insomnia Severity Index (ISI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda L Chao, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Health Care System | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33549595 | Background | Chao LL, Kanady JC, Crocker N, Straus LD, Hlavin J, Metzler TJ, Maguen S, Neylan TC. Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. Life Sci. 2021 Aug 15;279:119147. doi: 10.1016/j.lfs.2021.119147. Epub 2021 Feb 4. |
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Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
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The study statistician who will analyze outcome data will be blinded to group assignment.
|
| Sleep Education (SE) | Behavioral | 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. |
|
| Change from baseline to 3 months after treatment ends. |
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. |
| Change from baseline to 3 months after treatment ends. |