Clinical trial NCT02661997: Novel Interventions for GWVI
Official title: Novel Interventions for Gulf War Veterans' Illnesses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gulf War Veteran's Illness
Keywords: Tai Chi
Wellness
Mind-body
Gulf War Illness
Gulf War Veteran's Illness
GWVI
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Boston University
name: Tufts Medical Center
First posted: 2016-01-25
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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 was 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.

This randomized trial aimed to establish the effectiveness of a Tai Chi mind-body treatment in Veterans with GWVI. One hundred and fourteen participants meeting criteria for GWVI were 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 addressed 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 hypothesized 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 hypothesized 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 fourteen GW Veterans meeting criteria for GWVI were randomly assigned to either the Tai Chi Condition (n=58) or the Wellness Condition (n=56).

Methodology: Participants received 12 weeks of the randomly-assigned intervention twice each week. Assessments were conducted at baseline, 12 weeks (post-intervention), 24 weeks (3 months post-intervention) and 48 weeks (9 months post-intervention). Assessments included instruments to measure self-reported pain, fatigue, cognition, quality of life, and physical functioning.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
timeFrame: Change from baseline to post-treatment at 12 weeks
Secondary outcomes:
measure: Change in Multi-dimensional Fatigue Inventory (MFI-20)
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: PROMIS Global Health Scale - Physical Health Subscale
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: 50 Foot Walk Test
timeFrame: Change from baseline to post-treatment (12 weeks)
measure: Short Physical Performance Battery (SPPB) - 4-Meter Walk Test
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Change in Trail Making Test (TMT) - Trails A
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: PROMIS Global Health Scale - Mental Health Subscale
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)
timeFrame: Change from baseline to post-treatment at 12 weeks
measure: Change in Trail Making Test (TMT) - Trails B
timeFrame: Change from baseline to post-treatment at 12 weeks
Other outcomes:
measure: Change in Health Symptom Checklist (HSC)
timeFrame: Change from baseline HSC at 12 weeks
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline PCL-5 at 12 weeks
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Change from baseline ISI at 12 weeks
measure: Participant Compliance Log
timeFrame: 12 weeks
measure: Weekly Practice Log Sheet
timeFrame: 12 weeks
measure: Client Satisfaction Questionnaire
timeFrame: 12 weeks
measure: Change in the Pain Catastrophizing Scale (PCS)
timeFrame: Change from baseline PCS at 12 weeks
measure: Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI)
timeFrame: Change from baseline WHYMPI at 12 weeks
measure: Change in Depression Anxiety Sensitivity Scale (DASS)
timeFrame: Change from baseline DASS at 12 weeks
measure: Change in Chronic Pain Self-Efficacy Scale (CPSS)
timeFrame: Change from baseline CPSS at 12 weeks
measure: Group Cohesiveness Scale (GSC)
timeFrame: 12 weeks
measure: PROMIS Self-Efficacy for Managing Symptoms
timeFrame: Change from baseline PROMIS Self-Efficacy at 12 weeks
measure: Physical Activity Recall (PAR)
timeFrame: Change from baseline PAR at 12 weeks
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Change from baseline MAAS at 12 weeks
measure: Body Mass Index
timeFrame: Change from baseline measurements at 12 weeks
measure: Blood Pressure
timeFrame: Change from baseline measurements at 12 weeks
measure: The Epidemic - Pandemic Impacts Inventory (EPII)
timeFrame: Change from baseline EPII at 12 weeks
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Barbara L. Niles, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: DeAnna L Mori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.