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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure therapy with Hydrocortisone | Active Comparator |
| |
| Prolonged Exposure therapy with placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone augmented Prolonged Exposure Therapy | Other | 11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 0 |
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 12 |
| Clinician Administered PTSD Scale (CAPS) | Assessment of the severity of PTSD symptoms and of diagnosis of PTSD. | week 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Biological measures associated with PTSD | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. | week 0 |
| Biological measures associated with PTSD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Yehuda, PhD | Contact | 718-741-4000 | 6964 | rachel.yehuda@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Yehuda, PhD | James J Peters VAMC/Mount Sinai School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters Veterans Affairs Medical Center | Recruiting | The Bronx | New York | 10468 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Prolonged exposure therapy with placebo administration | Other | 11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered. |
|
Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor.
| week 12 |
| Biological measures associated with PTSD | Measures of neuroendocrinology, genotyping, gene expression, and methylation at glucocorticoid receptor. | week 23 |
| MATRICS Consensus Cognitive Battery (MCCB) | Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition. | week 0 |
| MATRICS Consensus Cognitive Battery (MCCB) | Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition. | week 12 |
| MATRICS Consensus Cognitive Battery (MCCB) | Measure of cognitive ability in the following domains: processing speed, attention, working memory (verbal and non-verbal), verbal learning, visual learning, reasoning and problem solving, and social cognition. | week 23 |
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 0 |
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 12 |
| Other measures of clinical, psychological, and functional outcome | Measures of symptom severity, trauma-related cognitions, and resiliency. | week 23 |