Novel Interventions for GWVI



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/6/2019
Start Date:June 1, 2017
End Date:March 31, 2021
Contact:Barbara L Niles, PhD
Email:Barbara.Niles@va.gov
Phone:(617) 232-9500

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Novel Interventions for Gulf War Veterans' Illnesses

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.

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.

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:

- musculoskeletal pain (muscle pain, joint pain, or stiffness)

- fatigue

- 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 criteria)

- 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.

- Reports ability to come to VA Boston, Jamaica Plain campus at the scheduled times of
group sessions.

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).
We found this trial at
1
site
Boston, Massachusetts 02130
Principal Investigator: Barbara L. Niles, PhD
Phone: 617-232-9500
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Boston, MA
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