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Relationship Between the Biological and Psychological Correlates of PTSD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00183300
First Posted: September 16, 2005
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Post-Traumatic Stress Disorder Behavioral: Prolonged Exposure Therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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

Estimated Enrollment: 120
Study Start Date: September 2001
Study Completion Date: July 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Edna B. Foa, Ph.D. University of Pennsylvania
Principal Investigator: Rachel Yehuda, Ph.D. Mt. Sinai School of Medicine
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00183300     History of Changes
Other Study ID Numbers: R01MH062003 ( U.S. NIH Grant/Contract )
DATR AD-TS
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: October 6, 2015
Last Verified: December 2007

Keywords provided by University of Pennsylvania:
Post-traumatic stress disorder
PTSD
Prolonged Exposure
Cognitive-Behavior Therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders