Novel Interventions for GWVI

Study Overview
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Brief Summary
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The primary aim of this study is to examine the beneficial effects of two novel treatments for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the efficacy of these mind-body approaches to symptom reduction.

Detailed Description
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Objectives: Over 40,000 Veterans who served in the 1991 Gulf War (GW) have a persistent form of chronic multisymptom illness that defines Gulf War Veterans Illness (GWVI). With no existing proven treatments to provide relief to these sufferers, it is critical to find efficacious and acceptable treatments for GWVI. The long-term goal is to develop a safe, readily available, mind-body treatment to reduce pain and other chronic symptoms and enhance wellness in Veterans with GWVI. Tai Chi is a traditional Chinese mind-body therapy that has been practiced for centuries. In the last decade, the investigators have demonstrated that Tai Chi can improve both physical health and psychological wellbeing in patients with a variety of chronic conditions. The proposed randomized trial will establish the effectiveness of a Tai Chi mind-body treatment in Veterans with GWVI. One hundred and twenty participants meeting criteria for GWVI will be randomly assigned to either a Tai Chi exercise or a wellness education group for 12 weeks with a post treatment assessment, and follow-up assessments. The investigators will accomplish the following Specific Aims: Specific Aim 1: Evaluate whether the Tai Chi intervention will reduce symptoms of pain in Veterans with GWVI more than the Wellness intervention. The investigators hypothesize that participants randomized to the Tai Chi intervention will show a greater reduction in pain symptoms than those in the Wellness intervention and will maintain changes over a 9-month follow-up period. Specific Aim 2: Evaluate whether the Tai Chi intervention improves fatigue, cognition, quality of life, and physical functioning in GW Veterans with GWVI, as compared to the Wellness intervention. The investigators hypothesize that participants randomized to the Tai Chi intervention will evidence more improvement in fatigue, cognitive functioning, quality of life, and physical functioning than those randomized to the Wellness intervention and will maintain changes over a 9-month follow-up period. Research Design: One hundred and twenty GW Veterans meeting criteria for GWVI will be randomly assigned to either the Tai Chi Condition or the Wellness Condition, half to each condition. Methodology: All participants will receive 12 weeks of the randomly-assigned intervention twice each week. Participants in both conditions will receive assessments at baseline, 12 weeks (post-intervention), 24 weeks (3 months post-intervention) and 48 weeks (9 months post-intervention). Assessments include instruments to measure self-reported pain, fatigue, cognition, quality of life, and physical functioning.

Official Title
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Novel Interventions for Gulf War Veterans' Illnesses

Conditions
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Gulf War Veteran's Illness

Intervention / Treatment
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* Behavioral: Tai Chi Intervention
* Behavioral: Wellness Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Served in the 1991 Gulf War. Meets criteria for chronic multisymptom illness (CMI) based on CDC criteria32 characterized by one or more symptoms of at least 6 months duration from at least two of three symptom categories: 1) musculoskeletal pain (muscle pain, joint pain, or stiffness); 2) fatigue; and 3) mood-cognition. One symptom of CMI must be musculoskeletal or joint pain or stiffness of at least 6 months duration (in addition to fatigue or cognitive complaints of the CDC criteria32). Not planning to relocate in next 3 months English-Speaking: English is the only language to be used during the exercise training program. Our self-reported outcome measures are obtained from validated English-version questionnaires. In addition, using other languages would likely require separate classes, recruitment and instructors which are beyond our current study scope. Has access to a home computer or device that will allow telehealth delivery of the intervention. Exclusion Criteria: Lacks the capacity to provide consent Major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury, which could interfere with their ability to safely engage in Tai Chi exercises. Change in psychotropic or pain medication during the past month This will minimize amount of symptom change due to medication alterations Once enrolled, medication changes are nonetheless expected and will be monitored Regular current Tai Chi, mindfulness, or yoga practice, defined as at least three hours per week for more than three months. Veterans with prior experience who do not currently engage in regular practice at this level will be eligible Reports difficulty standing on feet for the majority of a Tai Chi class (approximately 60 minutes). Participants who are disruptive or disrespectful or engage in behavior that threatens staff and/or participant safety may be terminated from the study. Participants who are currently involved in another treatment study that might confound our findings (e.g., treatments for GWI, pain).
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: Tai Chi Intervention<br>All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice. | Behavioral: Tai Chi Intervention<br>* All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.<br>|
| Active Comparator: Wellness Intervention<br>The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons. | Behavioral: Wellness Intervention<br>* The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory - Short Form (BPI) | The BPI is a 9-item self-report measure that examines pain intensity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. Although initially developed to assess pain in patients with cancer, it has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Participants rate their pain levels on a 0 to 10 Likert scale. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. There is strong psychometric support for its underlying factors of pain severity and pain interference. | Change from baseline Short Form BPI across 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Multi-dimensional Fatigue Inventory (MFI-20) | The MFI-20 is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales. | Change from baseline MFI-20 at 12 weeks | 
| Change in PROMIS Global Health Scale | The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities. | Change from baseline PROMIS Global Health Scale at 12 weeks | 
| 50 Foot Walk Test | Participants will walk 50 feet as quickly as they can as a study staff member times them. | Change from baseline 50 Foot Walk Test at 12 weeks | 
| Change in Short Physical Performance Battery (SPPB) | The SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each of the three performance measures are assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the test. A summary score (range 0-12) is subsequently calculated by adding the three scores. | Change from baseline SPPB at 12 weeks | 
| Change in Trail Making Test (TMT) | The TMT is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task. | Change from baseline TMT at 12 weeks | 
| Change in Hopkins Verbal Learning Test - Revised (HVLT-R) | The HVLT-R is a verbal learning and memory test, consisting of 12 nouns to be learned over the course of three learning trials. The administrator reads the list of words and the participant is asked to freely recall them immediately. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any word remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. The three learning trials are combined to calculate a total recall score, the delayed recall score and the retention percentage. All together, the HVLT takes approximately 10 minutes to administer. | Change from baseline HVLT-R at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi, Wellness, Mind-body, Gulf War Illness, Gulf War Veteran's Illness, GWVI