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Novel Interventions for GWVI (NIGWVI)

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ClinicalTrials.gov Identifier: NCT02661997
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Boston University
Tufts Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gulf War Veteran's Illness Behavioral: Tai Chi Intervention Behavioral: Wellness Intervention Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Interventions for Gulf War Veterans' Illnesses
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Tai Chi Intervention
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
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.

Active Comparator: Wellness Intervention
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
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.




Primary Outcome Measures :
  1. Change in Brief Pain Inventory - Short Form (BPI) [ Time Frame: Change from baseline Short Form BPI across 12 weeks ]
    The BPI is a 9-item self-report measure that examines pain intensity 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. Although initially developed to assess pain in patients with cancer, 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. Participants rate their pain levels on a 0 to 10 Likert scale. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. There is strong psychometric support for its underlying factors of pain severity and pain interference.


Secondary Outcome Measures :
  1. Change in Multi-dimensional Fatigue Inventory (MFI-20) [ Time Frame: Change from baseline MFI-20 at 12 weeks ]
    The MFI-20 is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales.

  2. Change in PROMIS Global Health Scale [ Time Frame: Change from baseline PROMIS Global Health Scale at 12 weeks ]
    The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities.

  3. 50 Foot Walk Test [ Time Frame: Change from baseline 50 Foot Walk Test at 12 weeks ]
    Participants will walk 50 feet as quickly as they can as a study staff member times them.

  4. Change in Short Physical Performance Battery (SPPB) [ Time Frame: Change from baseline SPPB at 12 weeks ]
    The SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each of the three performance measures are assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the test. A summary score (range 0-12) is subsequently calculated by adding the three scores.

  5. Change in Trail Making Test (TMT) [ Time Frame: Change from baseline TMT at 12 weeks ]
    The TMT is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task.

  6. Change in Hopkins Verbal Learning Test - Revised (HVLT-R) [ Time Frame: Change from baseline HVLT-R at 12 weeks ]
    The HVLT-R is a verbal learning and memory test, consisting of 12 nouns to be learned over the course of three learning trials. The administrator reads the list of words and the participant is asked to freely recall them immediately. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any word remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. The three learning trials are combined to calculate a total recall score, the delayed recall score and the retention percentage. All together, the HVLT takes approximately 10 minutes to administer.


Other Outcome Measures:
  1. Change in Health Symptom Checklist (HSC) [ Time Frame: Change from baseline HSC at 12 weeks ]
    A list of 34 frequently reported health and mental health symptoms rated as to how often in the past 30 days the symptoms were experienced. Symptoms from nine body systems are assessed (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, and psychological).

  2. Change in Kansas Gulf War Experiences and Exposures Questionnaire [ Time Frame: Change from baseline Kansas Gulf War Experiences and Exposures Questionnaire at 12 weeks ]
    This measure queries Veterans about demographics, military and deployment history and chronic symptoms and diagnoses required to ascertain Kansas and CMI case status.

  3. The PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Change from baseline PCL-5 at 12 weeks ]
    A newly developed self-report measure consisting of 20 items that parallel the recently released DSM-5 posttraumatic stress disorder criteria. Respondents indicate on a 5-point scale how much they have been bothered in the last month by particular symptoms that are related to stressful military experiences. The DSM-IV version of the PCL has been shown to have excellent reliability and validity.

  4. Change in Insomnia Severity Index (ISI) [ Time Frame: Change from baseline ISI at 12 weeks ]
    The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is comprised of seven questions. The seven answers are added up to get a total score, fitting into one of four categories: no clinically significant insomnia, subthreshold insomnia, clinical insomnia (moderate severity), clinical insomnia (severe).

  5. Participant Compliance Log [ Time Frame: 12 weeks ]
    Study staff will monitor number of missed Tai Chi classes, reasons given for missing the classes, and attendance at assessment sessions.

  6. Weekly Practice Log Sheet [ Time Frame: 12 weeks ]
    This measure will monitor compliance with home Tai Chi practice.

  7. Tai Chi Satisfaction Questionnaire [ Time Frame: 12 weeks ]
    This measure will assess satisfaction with the Tai Chi intervention.

  8. Wellness Satisfaction Questionnaire [ Time Frame: 12 weeks ]
    This measure will assess satisfaction with the Wellness intervention.

  9. Change in the Pain Catastrophizing Scale (PCS) [ Time Frame: Change from baseline PCS at 12 weeks ]
    The PCS is a 13-item self-report scale that assesses the degree to which people engage in three subtypes of pain catastrophizing: rumination, magnification, and helplessness. It is one of the most widely used instruments for measuring catastrophic thinking in relation to pain.

  10. Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) [ Time Frame: Change from baseline WHYMPI at 12 weeks ]
    The WHMPI is a well-validated measure of several important dimensions of chronic pain experience it has been demonstrated to be applicable across a variety of clinical pain conditions including chronic low back pain, temporomandibular disorders, headaches, fibromyalgia, and cancer pain. The WHYMPI is a 52-item, 12-scale inventory that is divided into three parts. Patient's responses to WHYMPI items are made on a 7-point scale.

  11. Change in ACR Fibromyalgia Diagnostic Criteria & Graphic for Polysymptomatic Distress Scale (2014) [ Time Frame: Change from baseline PDS across 12 weeks ]
    This series of questions gathers information about patients Widespread Pain Index (WPI) score, assessing for Fibromyalgia. The graphic is used to help patients identify where in the bodies they have experienced pain or tenderness in the past week.

  12. Change in Depression Anxiety Sensitivity Scale (DASS) [ Time Frame: Change from baseline DASS at 12 weeks ]
    The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

  13. Change in Chronic Pain Self-Efficacy Scale (CPSS) [ Time Frame: Change from baseline CPSS at 12 weeks ]
    The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. Questions are broken down into three categories: self-efficacy for pain management, self-efficacy for physical function, and self-efficacy for coping with symptoms. Each item in the CPSS is presented as a question (e.g., "How certain are you that you can decrease your pain quite a bit?"). The patients rates each belief on a 10-point Likert scale anchored on the ends by 10 = very' uncertain and 100 = very certain.

  14. Group Cohesiveness Scale (GSC) [ Time Frame: 12 weeks ]
    The GSC is a 5-item self-report measure that examines group cohesion within a therapeutic atmosphere.

  15. PROMIS Self-Efficacy for Managing Symptoms [ Time Frame: Change from baseline PROMIS Self-Efficacy at 12 weeks ]
    The PROMIS Self Efficacy for Managing Symptoms is an 8-item self-report measure that examines elements of self-care.

  16. Physical Activity Recall (PAR) [ Time Frame: Change from baseline PAR at 12 weeks ]
    The PAR is a measure that will be administered by the study staff in an interview format. The PAR examines participants' physical activity over the past week and time spent sleeping.

  17. Mindfulness Attention Awareness Scale (MAAS) [ Time Frame: Change from baseline MAAS at 12 weeks ]
    The MAAS is a 15-item self-report measure that assesses participants' openness towards, awareness of, and attention to the present. This scale can reveal information about one's self-regulation and well-being.

  18. Body Mass Index [ Time Frame: Change from baseline measurements at 12 weeks ]
    Study staff will record participants' height, weight. Weight and height will be combined to report BMI in kg/m^2

  19. Blood Pressure [ Time Frame: Change from baseline measurements at 12 weeks ]
    Systolic and diastolic pressures will be measured in mmHg using a blood pressure cuff and sphygmomanometer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661997


Contacts
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Contact: Barbara L Niles, PhD (617) 232-9500 ext 44121 Barbara.Niles@va.gov
Contact: Deanna L Mori, PhD (857) 361-4121 deanna.mori@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Barbara L Niles, PhD    617-232-9500 ext 44121    Barbara.Niles@va.gov   
Contact: Deanna L Mori, PhD    (857) 361-4121    deanna.mori@va.gov   
Principal Investigator: Barbara L. Niles, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Boston University
Tufts Medical Center
Investigators
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Principal Investigator: Barbara L. Niles, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02661997     History of Changes
Other Study ID Numbers: SPLD-004-15S
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Tai Chi
Wellness
Mind-body
Gulf War Illness
Gulf War Veteran's Illness
GWVI