CAM in Veterans With Gulf War Illnesses

Study Overview
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Brief Summary
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The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (mindfulness meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).

Detailed Description
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Gulf War Veterans have reported irritable bowel syndrome, chronic fatigue, musculoskeletal pain, sleep difficulties, and neurocognitive dysfunction (for example, concentration, memory, and attention problems). The most effective treatment approach for what appears to a broad spectrum problem found in GWVI may require complementary alternative medicine (CAM) approaches to enhance positive outcomes. Mindfulness meditation and acupuncture are each broad spectrum CAM treatments designed to target multiple biological systems simultaneously, and thus may be well suited for GWVI. Gulf War Health Education group will promote wellness and prevention by utilizing a proactive patient care model.

Official Title
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CAM in Veterans With Gulf War Illnesses

Conditions
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Gulf War Veterans' Illness

Intervention / Treatment
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* Behavioral: Mindfulness meditation/Acupuncture
* Other: Gulf War Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: U.S. Veteran Deployed to the Gulf War between 1990-1991 Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment) Exclusion Criteria: Addiction to drugs or alcohol Experiences hallucinations or delusions Currently manic Currently suicidal Hearing difficulties that would interfere with group participation Current involvement in a meditation or acupuncture group

Ages Eligible for Study
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Minimum Age: 18 Years

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: Mindfulness meditation/Acupuncture<br>Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. | Behavioral: Mindfulness meditation/Acupuncture<br>* Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.<br>|
| Active Comparator: Gulf War Health Education<br>Eligible participants may be randomized to participate in Gulf War Health Education group classes. | Other: Gulf War Health Education<br>* Participants randomized to this group will take part in a health education group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans RAND 36-item Health Survey - Mental Component Summary Scale | The MCS is comprised of questions about role-emotional, vitality/mental health and social functioning. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes. | 8 weeks | 
| Veterans RAND 36-Item Health Survey - Physical Component Summary Scale | The PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes. | 8 weeks | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a | An eight-item self-reported pain instrument designed at the National Institutes of Health (NIH) to measure the extent to which pain interferes with involvement in cognitive, emotional, physical, recreational, and social activities. Higher scores represent greater symptom severity. Range from 0 - 32. | 8 weeks | 
| Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a | An 8-item NIH instrument consisting of eight items that asks about the experience and impact of fatigue. Higher scores represent greater symptom severity. Range from 0 - 32. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-form McGill Pain Questionnaire (SF-MPQ-2) | The SF-MPQ-2 measures continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors. Higher scores indicate greater pain. Symptomatic pain on scale from 0 - 45. | 8 weeks | 
| Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) | The MFSI is a 30-item measurement tool that assesses the multidimensional nature of fatigue across five domains: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The range is from 24 to 96 with a higher score indicating higher levels of fatigue. | 8 weeks | 
| Quality of Life in Neurological Disorders (Neuro-QoL) | The items were selected from the 18 item Neuro-QOL Bank v1.0 - Applied Cognition - General Concerns. Scores range from 1 (very often) to 5 (none) for each cognitive symptom. Higher scores indicate better cognitive function. Range from 18 - 90. | 8 weeks | 
| Patient Health Questionnaire-Depression Module (PHQ-9) | The PHQ is a 9-item questionnaire, used to assess symptoms and functional impairment of depression to derive an overall severity score and a tentative depression diagnosis. Each item score ranges from 0-3 with higher scores indicating more severe depressive symptoms. Range from 0 - 27. | 8 weeks | 
| Posttraumatic Symptom Checklist - Civilian Version (PCL-C) | The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria with a range of 17-85. Higher scores indicate greater symptom expression. | 8 weeks | 
| Perceived Stress Scale (PSS) | The PSS is a 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. Scores range from 0 to 40 with higher scores indicating higher perceived stress. | 8 weeks | 
| The Brief Symptom Inventory (BSI) | The Brief Symptom Inventory is a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 =not at all to 4=extremely) in the past week by various symptoms. Each subscale is averaged for all items, whereby a score of 4 would indicate the highest possible score. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meditation, acupuncture, Gulf War Veterans' Illness, Gulf War health education, iRest yoga