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Relationship Between the Biological and Psychological Correlates of PTSD

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-traumatic stress disorder, PTSD, Prolonged Exposure, Cognitive-Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Chronic post-traumatic stress disorder Minimum of 3 months passed since traumatic event happened Agree to use an effective form of contraception throughout the study Exclusion Criteria: History of schizophrenia, bipolar disorder, or cognitive dysfunction due to a general medical condition History of alcohol or other drug abuse or dependence within 3 months of study enrollment Mental retardation or other pervasive developmental disorder Unwillingness or inability to discontinue current psychotherapy treatment (stable psychiatric medication therapy taken during the study is not criteria for exclusion) Significant risk of violence or history of serious violent behavior within one year of study enrollment Medically unstable condition Continuing intimate relationship with the perpetrator when the trauma involves assault At risk for suicide risk Currently pregnant

Sites / Locations

  • Center for the Treatment and Study of Anxiety, University of Pennsylvania

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
October 2, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183300
Brief Title
Relationship Between the Biological and Psychological Correlates of PTSD
Official Title
Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Post-traumatic stress disorder, PTSD, Prolonged Exposure, Cognitive-Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Primary Outcome Measure Information:
Title
PTSD severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up
Title
Salivary cortisol; measured immediately after 10 weeks of treatment
Title
Urinary cortisol and catecholamines; measured immediately after 10 weeks of treatment and at 6-month follow-up
Secondary Outcome Measure Information:
Title
Depression; measured by the BDI immediately after 10 weeks of treatment and at 6-month follow-up
Title
State-anxiety; measured by the STAI-S immediately after 10 weeks of treatment and at 6-month follow-up.
Title
Trauma-related cognitions; measured by the PTCI immediately after 10 weeks of treatment and at 6-month follow-up
Title
Salivary cortisol; measured at 6-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic post-traumatic stress disorder Minimum of 3 months passed since traumatic event happened Agree to use an effective form of contraception throughout the study Exclusion Criteria: History of schizophrenia, bipolar disorder, or cognitive dysfunction due to a general medical condition History of alcohol or other drug abuse or dependence within 3 months of study enrollment Mental retardation or other pervasive developmental disorder Unwillingness or inability to discontinue current psychotherapy treatment (stable psychiatric medication therapy taken during the study is not criteria for exclusion) Significant risk of violence or history of serious violent behavior within one year of study enrollment Medically unstable condition Continuing intimate relationship with the perpetrator when the trauma involves assault At risk for suicide risk Currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edna B. Foa, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Yehuda, Ph.D.
Organizational Affiliation
Mt. Sinai School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for the Treatment and Study of Anxiety, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Relationship Between the Biological and Psychological Correlates of PTSD

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