Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183300
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2005-09-12
Brief Title:
Relationship Between the Biological and Psychological Correlates of PTSD
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR AD-TS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH062003 |
| R01MH062003 | NIH | None | None |