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To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | After six (6) hours of the accident, subject will take 5 mg of DEX in the Emergency Department (ED). Within twenty-four (24) hours, the subjects will send in a saliva sample. After sexen (7) days, subjects will participate in a phone interview. After thirty (30) days, subjects will participate in an online assessment and return for a one month follow-up visit. Subjects will then participate in online assessments at months 3,6,9, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5) | Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test. | 1 month, 3 months, 6 months, 9 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol Levels measured from saliva samples | 24 hours post ED departure | |
| Score on Subjective Units of Distress (SUDS) | Scale of 0 to 10 for measuring the subjective intensity of disturbance or distress currently experienced by an individual. The individual self assesses where they are on the scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Galatzer-Levy, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003130 | Combat Disorders |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
|
| 1 month, 3 months, 6 months, 9 months, and 12 months |
| Score on the Kessler 6 Scale | Measure of Psychological distress in the anxiety-depression spectrum | 1 month, 3 months, 6 months, 9 months, and 12 months |
| Score on Life Satisfaction Scale | The Satisfaction with Life Scale to assess satisfaction with people's lives as a whole. The scale does not assess satisfaction with specific life domains, such as health or finances, but allows subjects to integrate and weigh these domains in whatever way they choose. | 1 month, 3 months, 6 months, 9 months, and 12 months |
| Score on Center for Epidemiologic Studies Depression Scale (CES-D) | 1 month, 3 months, 6 months, 9 months, and 12 months |
| Score on Perceived Ability to Cope with Trauma Scale (PACT) | 1 month, 3 months, 6 months, 9 months, and 12 months |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |