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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180243
Other study ID # SPLD-013-13S
Secondary ID CX000801-01A2
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2016
Est. completion date October 1, 2021

Study information

Verified date October 2022
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 1, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness meditation/Acupuncture
Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.
Other:
Gulf War Health Education
Participants randomized to this group will take part in a health education group.

Locations

Country Name City State
United States Washington DC VA Medical Center, Washington, DC Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Georgetown University, MedStar Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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