Relationship Between the Biological and Psychological Correlates of PTSD
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|ClinicalTrials.gov Identifier: NCT00183300|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: Prolonged Exposure Therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women|
|Study Start Date :||September 2001|
|Study Completion Date :||July 2007|
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183300
|United States, Pennsylvania|
|Center for the Treatment and Study of Anxiety, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Edna B. Foa, Ph.D.||University of Pennsylvania|
|Principal Investigator:||Rachel Yehuda, Ph.D.||Mt. Sinai School of Medicine|