CAM in Veterans With Gulf War Illnesses (GW-CAM)

The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (mindfulness meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).

Study Overview

• Status: Completed
• Conditions: Gulf War Veterans' Illness
• Intervention / Treatment: Other: Gulf War Health Education; Behavioral: Mindfulness meditation/Acupuncture

Detailed Description

Gulf War Veterans have reported irritable bowel syndrome, chronic fatigue, musculoskeletal pain, sleep difficulties, and neurocognitive dysfunction (for example, concentration, memory, and attention problems). The most effective treatment approach for what appears to a broad spectrum problem found in GWVI may require complementary alternative medicine (CAM) approaches to enhance positive outcomes. Mindfulness meditation and acupuncture are each broad spectrum CAM treatments designed to target multiple biological systems simultaneously, and thus may be well suited for GWVI. Gulf War Health Education group will promote wellness and prevention by utilizing a proactive patient care model.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VA Medical Center, Washington, DC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• U.S. Veteran
• Deployed to the Gulf War between 1990-1991
• Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)

Exclusion Criteria:

• Addiction to drugs or alcohol
• Experiences hallucinations or delusions
• Currently manic
• Currently suicidal
• Hearing difficulties that would interfere with group participation
• Current involvement in a meditation or acupuncture group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gulf War Health Education; Eligible participants may be randomized to participate in Gulf War Health Education group classes.	Other: Gulf War Health Education; Participants randomized to this group will take part in a health education group.
Experimental: Mindfulness meditation/Acupuncture; Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes.	Behavioral: Mindfulness meditation/Acupuncture; Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veterans RAND 36-item Health Survey - Mental Component Summary Scale	The MCS is comprised of questions about role-emotional, vitality/mental health and social functioning. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.	8 weeks
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale	The PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.	8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a	An eight-item self-reported pain instrument designed at the National Institutes of Health (NIH) to measure the extent to which pain interferes with involvement in cognitive, emotional, physical, recreational, and social activities. Higher scores represent greater symptom severity. Range from 0 - 32.	8 weeks
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a	An 8-item NIH instrument consisting of eight items that asks about the experience and impact of fatigue. Higher scores represent greater symptom severity. Range from 0 - 32.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-form McGill Pain Questionnaire (SF-MPQ-2)	The SF-MPQ-2 measures continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors. Higher scores indicate greater pain. Symptomatic pain on scale from 0 - 45.	8 weeks
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)	The MFSI is a 30-item measurement tool that assesses the multidimensional nature of fatigue across five domains: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The range is from 24 to 96 with a higher score indicating higher levels of fatigue.	8 weeks
Quality of Life in Neurological Disorders (Neuro-QoL)	The items were selected from the 18 item Neuro-QOL Bank v1.0 - Applied Cognition - General Concerns. Scores range from 1 (very often) to 5 (none) for each cognitive symptom. Higher scores indicate better cognitive function. Range from 18 - 90.	8 weeks
Patient Health Questionnaire-Depression Module (PHQ-9)	The PHQ is a 9-item questionnaire, used to assess symptoms and functional impairment of depression to derive an overall severity score and a tentative depression diagnosis. Each item score ranges from 0-3 with higher scores indicating more severe depressive symptoms. Range from 0 - 27.	8 weeks
Posttraumatic Symptom Checklist - Civilian Version (PCL-C)	The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria with a range of 17-85. Higher scores indicate greater symptom expression.	8 weeks
Perceived Stress Scale (PSS)	The PSS is a 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. Scores range from 0 to 40 with higher scores indicating higher perceived stress.	8 weeks
The Brief Symptom Inventory (BSI)	The Brief Symptom Inventory is a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Each subscale is averaged for all items, whereby a score of 4 would indicate the highest possible score.	8 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Georgetown University; MedStar Hospitals
• Investigators: Principal Investigator: Matthew J. Reinhard, PsyD, Washington DC VA Medical Center, Washington, DC

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimated): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: meditation; acupuncture; Gulf War Veterans' Illness; Gulf War health education; iRest yoga
• Other Study ID Numbers: SPLD-013-13S; CX000801-01A2 (Other Grant/Funding Number: VA CSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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