N/A
N=149
CAM in Veterans With Gulf War Illnesses
Gulf War Veterans' Illness
Bottom Line
View on ClinicalTrials.gov: NCT02180243 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Veterans RAND 36-item Health Survey - Mental Component Summary Scale — 42.26; 41.75; 44.48; 40.62 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness meditation/Acupuncture (Behavioral); Gulf War Health Education (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Veterans RAND 36-item Health Survey - Mental Component Summary Scale |
42.26; 41.75; 44.48; 40.62 | — |
| PRIMARY Veterans RAND 36-Item Health Survey - Physical Component Summary Scale |
37.02; 37.00; 39.41; 35.69 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a |
17.90; 17.47; 14.55; 17.77 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a |
20.92; 20.74; 17.69; 20.58 | — |
| SECONDARY Short-form McGill Pain Questionnaire (SF-MPQ-2) |
16.88; 17.01; 15.80; 19.42 | — |
| SECONDARY Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) |
37.40; 37.78; 27.69; 38.17 | — |
| SECONDARY Quality of Life in Neurological Disorders (Neuro-QoL) |
48.85; 49.11; 55.18; 48.65 | — |
| SECONDARY Patient Health Questionnaire-Depression Module (PHQ-9) |
11.64; 12.29; 9.76; 13.32 | — |
| SECONDARY Posttraumatic Symptom Checklist - Civilian Version (PCL-C) |
31.95; 31.63; 26.06; 34.71 | — |
| SECONDARY Perceived Stress Scale (PSS) |
18.68; 18.41; 17.24; 19.17 | — |
| SECONDARY The Brief Symptom Inventory (BSI) |
1.12; 1.16; 0.97; 1.32 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02180243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.