Novel Interventions for GWVI

NCT02661997 | Completed Results

• 1 other identifier: SPLD-004-15S
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gulf War Veteran's Illness

Keywords

Tai Chi; Wellness; Mind-body; Gulf War Illness; Gulf War Veteran's Illness; GWVI

Outcome Measures

Primary Outcomes (2)

• Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference

  The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity 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. 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. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

  Change from baseline to post-treatment at 12 weeks

• Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity

  The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity 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. 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. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

  Change from baseline to post-treatment at 12 weeks

Secondary Outcomes (10)

• Change in Multi-dimensional Fatigue Inventory (MFI-20)

  Change from baseline to post-treatment at 12 weeks

• PROMIS Global Health Scale - Physical Health Subscale

  Change from baseline to post-treatment at 12 weeks

• 50 Foot Walk Test

  Change from baseline to post-treatment (12 weeks)

• Change in Trail Making Test (TMT) - Trails A

  Change from baseline to post-treatment at 12 weeks

• Change in Trail Making Test (TMT) - Trails B

  Change from baseline to post-treatment at 12 weeks

Other Outcomes (24)

• Health Symptom Checklist (HSC)

  Change from baseline HSC at 12 weeks

• The PTSD Checklist for DSM-5 (PCL-5)

  Change from baseline PCL-5 at 12 weeks

• Insomnia Severity Index (ISI)

  Change from baseline ISI at 12 weeks

Study Arms (2)

Tai Chi Intervention

EXPERIMENTAL

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

Wellness Intervention

ACTIVE COMPARATOR

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

Interventions

Tai Chi Intervention BEHAVIORAL

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.

Tai Chi Intervention

Wellness Intervention BEHAVIORAL

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.

Wellness Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Boston University: collaborator
• Tufts Medical Center: collaborator

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Related Publications (1)

• Niles BL, Grossman S, McQuade M, Grossman D, Kaiser AP, Muccio B, Warner B, Wang C, Mori DL. Study protocol for a revised randomized trial: Remotely delivered Tai Chi and wellness for Gulf War illness. Contemp Clin Trials. 2023 Feb;125:107045. doi: 10.1016/j.cct.2022.107045. Epub 2022 Dec 6.

  PMID: 36494045 BACKGROUND

Related Links

• IRB approved webpage - Novel Interventions for Gulf War Illness study

Results Point of Contact

• Title: Barbara L. Niles, Ph.D.
• Organization: VA Boston Healthcare System

barbara.niles@va.gov

857-364-4128

Study Officials

• Barbara L. Niles, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

• DeAnna L Mori, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 25, 2016
• Study Start: June 1, 2017
• Primary Completion: September 29, 2023
• Study Completion: September 30, 2025
• Last Updated: November 13, 2025
• Results First Posted: November 7, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)