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| Name | Class |
|---|---|
| Lightfighter Trust | UNKNOWN |
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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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure therapy | Behavioral | 10 weekly sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) | week 0 | |
| PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) | week 10 | |
| PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance (learning and retention in an episodic memory task, attention and working memory) | week 0 | |
| Cognitive performance (learning and retention in an episodic memory task, attention and working memory) | week 10 |
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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 |
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| 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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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Hydrocortisone | Drug | 30mg 20 minutes prior to each PE session including imaginal exposure (8 total) |
|
| Prolonged Exposure therapy | Behavioral | 10 weekly sessions |
|
| Cognitive performance (learning and retention in an episodic memory task, attention and working memory) | week 16 |
| Other measures of clinical outcome, psychological state and functioning | week 0 |
| Other measures of clinical outcome, psychological state and functioning | week 10 |
| Other measures of clinical outcome, psychological state and functioning | week 16 |
| Biological measures associated with PTSD severity | week 0 |
| Biological measures associated with PTSD severity | week 10 |
| Biological measures associated with PTSD severity | week 16 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |