Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Veterans Short Form 36-Item Health Survey Physical Component Summary |
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
Secondary |
Multidimensional Fatigue Inventory (MFI) |
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
Secondary |
Gulf War Illness Health Symptom Checklist |
The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms. |
Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28 |
|
Secondary |
Brief Pain Inventory |
The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
Secondary |
Pittsburgh Sleep Quality Index |
The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
Secondary |
Hamilton Anxiety Scale (HAM-A) |
This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Hamilton Depression Scale (HAM-D) |
This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) |
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
Secondary |
Connors Continuous Performance Test (CPT-3): Hit Reaction Time |
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Connors Continuous Performance Test (CPT-3):Omissions T-score |
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Connors Continuous Performance Test (CPT-3):Commissions T-score |
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Brief Visual Memory Test (BVMT): Delayed Recall |
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Brief Visual Memory Test (BVMT): Percent Retained |
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 |
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
California Verbal Learning Test (CVLT-II): Short Delay |
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
California Verbal Learning Test (CVLT-II): Long Delay Test |
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Davidson Trauma Scale |
Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
FitBit Sleep Measurement - Total Sleep |
FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available. |
Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks |
|
Secondary |
FitBit Sleep Measurement - Types of Sleep |
FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available. |
Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks |
|
Secondary |
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets |
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts |
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages |
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin |
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit |
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH |
Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 |
Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 |
Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Cortisol Levels |
Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm. |
Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each. |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone |
HPG will measure testosterone. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone |
HPG will measure progesterone. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|
Secondary |
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol |
HPG will measure estradiol. Average values fell within the normal range for this type of assay. |
Baseline, Weeks 8, 16, and 24 |
|