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This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.
A randomized controlled trial with two arms. 55 veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures were collected at baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months following completion of the MBSR course. Measures were obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only had the opportunity to enroll in MBSR.
This pilot study will whether there is sufficient evidence of benefit to warrant further study, and gathered data that will allow estimation of the sample size needed in future studies. We also obtained measures working memory and attention, in addition to patient self-report measures of symptoms, in order to provide additional assessment of whether MBSR is effective. This project is prerequisite to a larger study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course |
|
| Arm 2 | No Intervention | Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction | Behavioral | Mindfulness-Based Stress Reduction (MBSR) teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon. |
| Measure | Description | Time Frame |
|---|---|---|
| The Short-form McGill Pain Questionnaire | The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome. | 2 months |
| The Short-Form McGill Pain Questionnaire | The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome. | 8 months |
| Multidimensional Fatigue Inventory - General Fatigue | The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome. | 2 months |
| Multidimensional Fatigue Inventory - General Fatigue | The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome. | 8 months |
| Cognitive Failures Questionnaire | The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. "feeling tired or having little energy"), from "not at all" (0), to "nearly every day" (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome. |
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Inclusion Criteria:
Chart Diagnosis of PTSD
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Kearney, MD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction. Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called "mindfulness-based stress reduction" (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon. |
| FG001 | Arm 2 | Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-month Outcomes |
| |||||||||||||
| 6-month Outcome |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction. Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called "mindfulness-based stress reduction" (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Short-form McGill Pain Questionnaire | The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
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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 | Arm 1 | Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course. The most common clinical method of teaching mindfulness is a standardized class called "mindfulness-based stress reduction" (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pains | Cardiac disorders | Non-systematic Assessment | The patient was admitted to Tacoma General Hospital for chest pain. He is reported to have had a small cardiac event, and had sent placed as treatment. The IRB determined that this event was probably NOT related to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Kearney, MD | VA Puget Sound Health Care System | 206-277-1445 | David.Kearney@VA.gov |
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| ID | Term |
|---|---|
| D018923 | Persian Gulf Syndrome |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| 2 months |
| Cognitive Failures Questionnaire | The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome. | 8 months |
| 2 months |
| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. "feeling tired or having little energy"), from "not at all" (0), to "nearly every day" (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome. | 8 months |
| PTSD Symptom Severity Interview (PSSI) | The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. "Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?") by indicating how often per week he or she experiences that symptom. For each item, "not at all" is scored as 0; "once per week or less/a little" is scored as 1; "2 to 4 times per week/somewhat" is scored as 2; and "5 or more times per week/very much" is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome. | 2 months |
| PTSD Symptom Severity Interview (PSSI) | The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. "Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?") by indicating how often per week he or she experiences that symptom. For each item, "not at all" is scored as 0; "once per week or less/a little" is scored as 1; "2 to 4 times per week/somewhat" is scored as 2; and "5 or more times per week/very much" is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome. | 8 months |
| PROMIS Fatigue | The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. "How often did you feel tired?) with the following scale:
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue. | 2 months |
| PROMIS Fatigue | The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. "How often did you feel tired?) with the following scale:
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue. | 8 months |
| Five Facet Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. "I disapprove of myself when I have irrational ideas") by indicating how often they agree with the statement on a scale of 1 ("never or very rarely true") to 5 ("very often or always true"). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness. | 2 months |
| Five Facet Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. "I disapprove of myself when I have irrational ideas") by indicating how often they agree with the statement on a scale of 1 ("never or very rarely true") to 5 ("very often or always true"). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness. | 8 months |
| NOT COMPLETED |
|
| BG001 | Arm 2 | Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| McGill Pain Questionnaire score | The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. | Mean | Standard Deviation | units on a scale |
|
| Multidimensional Fatigue Inventory | The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") | Mean | Standard Deviation | units on a scale |
|
| Cognitive Failures Questionnaire | The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). | Mean | Standard Deviation | units on a scale |
|
| PTSD Symptom Scale Interview | Mean | Standard Deviation | units on a scale |
|
| Medication Use at Baseline | This is a summary of the prevalence of medication use among the study participants. Since each participant could endorse anywhere from none of these medications to all four types of medication, the total number is unlikely to add up to the exact number of participants. | Number | participants |
|
| Musculoskeletal Pain | Number | participants |
|
| Neurologic Pain | Number | participants |
|
| Gastrointestinal Condition | Number | participants |
|
| Respiratory Conditions | Number | participants |
|
| OG001 | Arm 2 | Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.) |
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. "feeling tired or having little energy"), from "not at all" (0), to "nearly every day" (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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| Primary | The Short-Form McGill Pain Questionnaire | The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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|
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| Primary | Multidimensional Fatigue Inventory - General Fatigue | The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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|
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| Primary | Multidimensional Fatigue Inventory - General Fatigue | The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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| Primary | Cognitive Failures Questionnaire | The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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| Primary | Cognitive Failures Questionnaire | The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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| Secondary | Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. "feeling tired or having little energy"), from "not at all" (0), to "nearly every day" (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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| Secondary | PTSD Symptom Severity Interview (PSSI) | The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. "Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?") by indicating how often per week he or she experiences that symptom. For each item, "not at all" is scored as 0; "once per week or less/a little" is scored as 1; "2 to 4 times per week/somewhat" is scored as 2; and "5 or more times per week/very much" is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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| Secondary | PTSD Symptom Severity Interview (PSSI) | The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. "Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?") by indicating how often per week he or she experiences that symptom. For each item, "not at all" is scored as 0; "once per week or less/a little" is scored as 1; "2 to 4 times per week/somewhat" is scored as 2; and "5 or more times per week/very much" is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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| Secondary | PROMIS Fatigue | The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. "How often did you feel tired?) with the following scale:
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue. | Posted | Mean | Standard Deviation | T-score | 2 months |
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| Secondary | PROMIS Fatigue | The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. "How often did you feel tired?) with the following scale:
Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue. | Posted | Mean | Standard Deviation | T-score | 8 months |
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| Secondary | Five Facet Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. "I disapprove of myself when I have irrational ideas") by indicating how often they agree with the statement on a scale of 1 ("never or very rarely true") to 5 ("very often or always true"). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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| Secondary | Five Facet Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. "I disapprove of myself when I have irrational ideas") by indicating how often they agree with the statement on a scale of 1 ("never or very rarely true") to 5 ("very often or always true"). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness. | Posted | Mean | Standard Deviation | units on a scale | 8 months |
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| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Arm 2 | Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.) | 2 | 29 | 0 | 29 |
|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment | A participant expressed having suicidal and homicidal ideation during a follow-up assessment. The interview was terminated and the researcher escorted the patient to psychiatric emergency services. |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |