Last reviewed · How we verify

NCT02180243: GW-CAM

CAM in Veterans With Gulf War Illnesses

Completed NA Results posted Last updated 1 September 2023
What this trial tests

NA trial testing Mindfulness meditation/Acupuncture in Gulf War Veterans' Illness in 150 participants. Completed in 1 October 2021.

Timeline
12 May 2016
Primary endpoint
30 September 2021
1 October 2021

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment150
Start date12 May 2016
Primary completion30 September 2021
Estimated completion1 October 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Gulf War Veterans' Illness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Veterans RAND 36-item Health Survey - Mental Component Summary Scale Primary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture42.26± 8.56
Gulf War Health Education41.75± 8.46
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture44.48± 8.09
Gulf War Health Education40.62± 8.54
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale Primary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture37.02± 8.78
Gulf War Health Education37.00± 10.53
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture39.41± 8.78
Gulf War Health Education35.69± 10.99
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a Primary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture17.90± 8.96
Gulf War Health Education17.47± 9.30
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture14.55± 8.14
Gulf War Health Education17.77± 9.66
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a Primary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture20.92± 8.26
Gulf War Health Education20.74± 7.64
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture17.69± 9.13
Gulf War Health Education20.58± 8.65
Short-form McGill Pain Questionnaire (SF-MPQ-2) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture16.88± 8.75
Gulf War Health Education17.01± 9.58
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture15.80± 9.46
Gulf War Health Education19.42± 10.83
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture37.40± 22.56
Gulf War Health Education37.78± 23.57
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture27.69± 23.15
Gulf War Health Education38.17± 27.59
Quality of Life in Neurological Disorders (Neuro-QoL) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture48.85± 17.41
Gulf War Health Education49.11± 17.77
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture55.18± 18.39
Gulf War Health Education48.65± 18.99
Patient Health Questionnaire-Depression Module (PHQ-9) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture11.64± 6.42
Gulf War Health Education12.29± 7.47
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture9.76± 6.86
Gulf War Health Education13.32± 8.44
Posttraumatic Symptom Checklist - Civilian Version (PCL-C) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture31.95± 18.86
Gulf War Health Education31.63± 22.04
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture26.06± 18.84
Gulf War Health Education34.71± 22.66
Perceived Stress Scale (PSS) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture18.68± 7.07
Gulf War Health Education18.41± 8.44
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture17.24± 6.81
Gulf War Health Education19.17± 7.30
The Brief Symptom Inventory (BSI) Secondary · 8 weeks

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.

Baseline
GroupValue95% CI
Mindfulness Meditation / Acupuncture1.12± 0.73
Gulf War Health Education1.16± 0.86
Endpoint
GroupValue95% CI
Mindfulness Meditation / Acupuncture0.97± 0.76
Gulf War Health Education1.32± 0.99

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gulf War Illness: Mechanisms Underlying Brain Dysfunction and Promising Therapeutic Strategies.
    Dickey B, Madhu LN, Shetty AK. · · 2021 · cited 54× · PMID 33164782 · DOI 10.1016/j.pharmthera.2020.107716
  2. Gulf War Illness: A Randomized Controlled Trial Combining Mindfulness Meditation and Auricular Acupuncture.
    Breneman CB, Reinhard MJ, Allen N, Belouali A, et al · · 2023 · cited 2× · PMID 37151571 · DOI 10.1177/27536130231171854

Verify or expand the search:

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02180243.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing