Clinical trial NCT02180243: CAM in Veterans With Gulf War Illnesses
Official title: CAM in Veterans With Gulf War Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gulf War Veterans' Illness
Keywords: meditation
acupuncture
Gulf War Veterans' Illness
Gulf War health education
iRest yoga
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Georgetown University
name: MedStar Health
First posted: 2014-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Veterans RAND 36-item Health Survey - Mental Component Summary Scale
timeFrame: 8 weeks
measure: Veterans RAND 36-Item Health Survey - Physical Component Summary Scale
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a
timeFrame: 8 weeks
Secondary outcomes:
measure: Short-form McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: 8 weeks
measure: Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)
timeFrame: 8 weeks
measure: Quality of Life in Neurological Disorders (Neuro-QoL)
timeFrame: 8 weeks
measure: Patient Health Questionnaire-Depression Module (PHQ-9)
timeFrame: 8 weeks
measure: Posttraumatic Symptom Checklist - Civilian Version (PCL-C)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: The Brief Symptom Inventory (BSI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center, Washington, DC
name: Matthew J. Reinhard, PsyD
role: PRINCIPAL_INVESTIGATOR
References: