Post-Traumatic Stress Disorder Clinical Trial
Official title:
Effectiveness of Prolonged Exposure Therapy on Reducing Neuroendocrine-Related Symptoms of Post-Traumatic Stress Disorder in Women
Verified date | December 2007 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for the Treatment and Study of Anxiety, University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD severity; measured by the PSS-I immediately after 10 weeks of treatment and at 6-month follow-up | |||
Primary | Salivary cortisol; measured immediately after 10 weeks of treatment | |||
Primary | Urinary cortisol and catecholamines; measured immediately after 10 weeks of treatment and at 6-month follow-up | |||
Secondary | Depression; measured by the BDI immediately after 10 weeks of treatment and at 6-month follow-up | |||
Secondary | State-anxiety; measured by the STAI-S immediately after 10 weeks of treatment and at 6-month follow-up. | |||
Secondary | Trauma-related cognitions; measured by the PTCI immediately after 10 weeks of treatment and at 6-month follow-up | |||
Secondary | Salivary cortisol; measured at 6-month follow-up |
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