Novel Interventions for GWVI

Completed · Not applicable

Conditions studied: Gulf War Veteran's Illness

In brief

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.

Key facts

Study ID

NCT02661997

Run by

VA Office of Research and Development

People needed

114

Starts

2017-06-01

Expected to finish

2025-09-30

Last updated by the study team

2025-11-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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