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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH062003 | U.S. NIH Grant/Contract | View source | |
| DATR AD-TS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic incident in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. Chronic PTSD can also affect the neuroendocrine system by altering functionality of some chemicals in the brain, including cortisol and catecholamines (e.g., norepinephrine). This study will determine the effectiveness of immediate treatment with prolonged exposure therapy (PE) versus delaying treatment with PE in altering neuroendocrine-related symptoms of post-traumatic stress disorder in women.
This single-blind study will randomly assign two thirds of participants to PE therapy immediately following a traumatic event and one third to a waitlist condition (WL), in which they will receive no treatment until a later date. Participants assigned to receive PE will do so once weekly for 10 weeks. Participants assigned to the WL condition will receive no treatment for 10 weeks, and then will begin PE therapy once weekly for an additional 10 weeks. Study visits will occur at baseline, Week 10, and 6 months post-treatment for those in both conditions, with additional visits 10 weeks and 6 months post-PE therapy for those in the WL condition. Psychological measurements to be assessed at these visits will include PTSD symptoms, anxiety, depression, and PTSD-related cognitions. Physical assessments will include urine and saliva tests, as well as a dexamethasone-suppression test. Participants in the PE condition will also provide saliva samples at points throughout the study to monitor changes in cortisol and catecholamines.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure Therapy | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up | ||
| Salivary cortisol; measured immediately after 10 weeks of treatment | ||
| Urinary cortisol and catecholamines; measured immediately after 10 weeks of treatment and at 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Depression; measured by the BDI immediately after 10 weeks of treatment and at 6-month follow-up | ||
| State-anxiety; measured by the STAI-S immediately after 10 weeks of treatment and at 6-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edna B. Foa, Ph.D. | University of Pennsylvania | Principal Investigator |
| Rachel Yehuda, Ph.D. | Mt. Sinai School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Treatment and Study of Anxiety, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | 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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| Trauma-related cognitions; measured by the PTCI immediately after 10 weeks of treatment and at 6-month follow-up |
| Salivary cortisol; measured at 6-month follow-up |