CAM in Veterans With Gulf War Illnesses
GW-CAM
2 other identifiers
interventional
150
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedStudy Start
First participant enrolled
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedResults Posted
Study results publicly available
September 1, 2023
CompletedSeptember 1, 2023
October 1, 2022
5.4 years
June 30, 2014
October 19, 2022
October 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
Short-form McGill Pain Questionnaire (SF-MPQ-2)
8 weeks
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)
8 weeks
Quality of Life in Neurological Disorders (Neuro-QoL)
8 weeks
Patient Health Questionnaire-Depression Module (PHQ-9)
8 weeks
Posttraumatic Symptom Checklist - Civilian Version (PCL-C)
8 weeks
- +2 more secondary outcomes
Study Arms (2)
Mindfulness meditation/Acupuncture
EXPERIMENTALEligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes.
Gulf War Health Education
ACTIVE COMPARATOREligible participants may be randomized to participate in Gulf War Health Education group classes.
Interventions
Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.
Participants randomized to this group will take part in a health education group.
Eligibility Criteria
You may qualify if:
- U.S. Veteran
- Deployed to the Gulf War between 1990-1991
- Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Georgetown Universitycollaborator
- MedStar Healthcollaborator
Study Sites (1)
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422, United States
Related Publications (1)
Breneman CB, Reinhard MJ, Allen N, Belouali A, Chun T, Crock L, Duncan AD, Dutton MA. Gulf War Illness: A Randomized Controlled Trial Combining Mindfulness Meditation and Auricular Acupuncture. Glob Adv Integr Med Health. 2023 May 3;12:27536130231171854. doi: 10.1177/27536130231171854. eCollection 2023 Jan-Dec.
PMID: 37151571DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew Reinhard, PsyD
- Organization
- War Related Illness and Injury Study Center
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J. Reinhard, PsyD
Washington DC VA Medical Center, Washington, DC
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
- Masking Details
- RBANS assessment was blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 2, 2014
Study Start
May 12, 2016
Primary Completion
September 30, 2021
Study Completion
October 1, 2021
Last Updated
September 1, 2023
Results First Posted
September 1, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share