Novel Interventions for GWVI (NIGWVI)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Gulf War Veteran's Illness

Treatments: Behavioral: Wellness Intervention; Behavioral: Tai Chi Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02661997

SPLD-004-15S

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 121 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 2 patient groups

Tai Chi Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi Intervention

Wellness Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Wellness Intervention