Gulf War Veterans' IllnessGW-CAMNCT02180243
CAM in Veterans With Gulf War Illnesses
A study testing Mindfulness meditation/Acupuncture and Gulf War Health Education in people with Gulf War Veterans' Illness, run by VA Office of Research and Development at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gulf War Veterans' Illness
- What is being tested?
- Mindfulness meditation/Acupuncture and Gulf War Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2016to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- U.S. Veteran
- Deployed to the Gulf War between 1990-1991
- Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
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).
Read the 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.
- Conditions
- Gulf War Veterans' Illness
- Being tested
- Mindfulness meditation/Acupuncture, Gulf War Health Education
- Keywords
- meditation, acupuncture, Gulf War Veterans' Illness, Gulf War health education, iRest yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation/AcupunctureBehavioural
Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.
Gulf War Health EducationOther
Participants randomized to this group will take part in a health education group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation/Acupuncture | Experimental | Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. Receives: Behavioral: Mindfulness meditation/Acupuncture |
| Gulf War Health Education | Active comparator | Eligible participants may be randomized to participate in Gulf War Health Education group classes. Receives: Other: Gulf War Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study start12 May 2016
- Primary completion30 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gulf War Veterans' IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Georgetown University, MedStar Health
- Responsible party
- Sponsor
- Investigators
- Matthew J. Reinhard, PsyD, Principal investigator, Washington DC VA Medical Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180243
- Sponsor's protocol ID
- SPLD-013-13S
- Other IDs
- CX000801-01A2
- Acronym
- GW-CAM
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2014
- Last updated
- 1 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37151571
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAM in Veterans With Gulf War Illnesses
- ClinicalTrials.gov ID
- NCT02180243
- Acronym / sponsor ID
- GW-CAM / SPLD-013-13S
- Conditions
- Gulf War Veterans' Illness
- Keywords
- meditation, acupuncture, Gulf War Veterans' Illness, Gulf War health education, iRest yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Georgetown University, MedStar Health
- Study start
- 12 May 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Posted 1 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation/Acupuncture | Experimental | Behavioral: Mindfulness meditation/AcupunctureEligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. |
| Gulf War Health Education | Active comparator | Other: Gulf War Health EducationEligible participants may be randomized to participate in Gulf War Health Education group classes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- U.S. Veteran
- Deployed to the Gulf War between 1990-1991
- Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)
Key exclusion criteria (6 listed)
- Addiction to drugs or alcohol
- Experiences hallucinations or delusions
- Currently manic
- Currently suicidal
- Hearing difficulties that would interfere with group participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditation/AcupunctureIndividuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture. | Behavioural | Mindfulness meditation/Acupuncture |
| Gulf War Health EducationParticipants randomized to this group will take part in a health education group. | Other | Gulf War Health Education |
Primary outcome
Veterans RAND 36-item Health Survey - Mental Component Summary Scale
Time frame: 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.
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale
Time frame: 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a
Time frame: 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.
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a
Time frame: 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.
7 secondary outcomes
Short-form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: 8 weeks
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)
Time frame: 8 weeks
Quality of Life in Neurological Disorders (Neuro-QoL)
Time frame: 8 weeks
Patient Health Questionnaire-Depression Module (PHQ-9)
Time frame: 8 weeks
Posttraumatic Symptom Checklist - Civilian Version (PCL-C)
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Time frame: 8 weeks
The Brief Symptom Inventory (BSI)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37151571Breneman 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.
- Individual participant dataSharing planned: No
Related trials for Gulf War Veterans' Illness
RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome
Active, not recruitingObservational study
Cardiovascular and Neurovascular Regulation in GWI
Brain Blood Flow, Neurovascular Control
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Gulf War Syndrome, Adult Growth Hormone Deficiency
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Reinhard, PsyD principal investigator
Washington DC VA Medical Center, Washington, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation/Acupuncture and Gulf War Health Education in people with Gulf War Veterans' Illness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veterans RAND 36-item Health Survey - Mental Component Summary Scale (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.