Novel Interventions for GWVI (NCT02661997) | Clinical Trial Compass
CompletedNot Applicable
Novel Interventions for GWVI
United States114 participantsStarted 2017-06-01
Plain-language summary
The primary aim of this study was 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.
In March 2020 after 53 Veterans were randomized, this trial was halted due to the onset of COVID-19. In late 2020, we shifted from conducting an in-person study to a fully remote study with interventions delivered via synchronous video teleconferencing. We then randomized an additional 61 Veterans for a study grand total of 114 Veterans.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Ta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied Gulf War Veterans' Illness specifically — given that my symptoms match this condition, does the research from this completed trial offer any insights into treatments that might help with my pain interference and pain severity?
2Since this trial has already been completed, have the results been published, and if so, what did they show about whether the interventions actually reduced pain levels in Gulf War veterans?
3The trial was listed as Phase NA, which often means it wasn't a standard drug trial — can you tell me what kinds of interventions were actually tested, and whether any of them might be appropriate for me to try now outside of a trial setting?
4Because this trial is completed and I can no longer enroll, are there any follow-up or related studies currently recruiting that are building on what was learned here for Gulf War Veterans' Illness?
5How does Gulf War Veterans' Illness differ from other chronic pain or fatigue conditions, and would the findings from this trial apply to my specific symptom picture, or would standard pain management be a better starting point for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
Timeframe: Change from baseline to post-treatment at 12 weeks
2
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
Timeframe: Change from baseline to post-treatment at 12 weeks