Relationship Between the Biological and Psychological Correlates of PTSD
Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 6, 2015
December 1, 2007
September 12, 2005
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edna B. Foa, Ph.D.
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Rachel Yehuda, Ph.D.
Mt. Sinai School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
September 1, 2001
Study Completion
July 1, 2007
Last Updated
October 6, 2015
Record last verified: 2007-12