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| ID | Type | Description | Link |
|---|---|---|---|
| CX000801-01A2 | Other Grant/Funding Number | VA CSR&D |
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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| MedStar Health | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness meditation/Acupuncture | Experimental | Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. |
|
| Gulf War Health Education | Active Comparator | Eligible participants may be randomized to participate in Gulf War Health Education group classes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness meditation/Acupuncture | Behavioral | Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Reinhard, PsyD | Washington DC VA Medical Center, Washington, DC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37151571 | Derived | 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. |
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Of 187 Veterans who began the consent process, 37 did not meet inclusion criteria and 1 enrolled but did not complete the randomization procedure. Therefore, 149 Veterans were randomized.
Participants were recruited between May 2016 and September 2019 via flyers, internet postings with a link to the study recruitment webpage, referrals from primary care providers at the Washington, DC VAMC, and targeted outreach mailings to GW Veterans. Telephone or in-person interviews were conducted to determine eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Meditation / Acupuncture | Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. Yoga/Acupuncture: Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture. |
| FG001 | Gulf War Health Education | Eligible participants may be randomized to participate in Gulf War Health Education group classes. Gulf War Health Education: Participants randomized to this group will take part in a health education group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Some Veterans who completed consent did not complete baseline data collection and were withdrawn from the study at this point.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Meditation / Acupuncture | Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
Adverse events would be collected from baseline (0) until 12 month followups (1 year and 8 weeks from group interventions).
Some Veterans completed consent but did not complete their baseline data collection and were withdrawn from the study at that point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Meditation/Acupuncture | Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. Mindfulness meditation/Acupuncture: Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Reinhard, PsyD | War Related Illness and Injury Study Center | 202-745-8000 | 55785 | matthew.reinhard@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2020 | Sep 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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RBANS assessment was blinded
| Gulf War Health Education | Other | Participants randomized to this group will take part in a health education group. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Gulf War Health Education |
Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Married | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| OG001 | Gulf War Health Education | Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session. |
|
|
| 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Gulf War Health Education | Eligible participants may be randomized to participate in Gulf War Health Education group classes. Gulf War Health Education: Participants randomized to this group will take part in a health education group. | 0 | 73 | 0 | 73 | 0 | 73 |
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| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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