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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183690 |
This study will compare the effectiveness of prolonged exposure therapy versus active psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.
Condition | Intervention | Phase |
---|---|---|
Post-Traumatic Stress Disorder |
Procedure: Prolonged Exposure Therapy Procedure: Active Psychotherapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Treating Terror-Related PTSD in Adolescents |
Enrollment: | 60 |
Study Start Date: | September 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants receiving prolonged exposure therapy
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Procedure: Prolonged Exposure Therapy
Prolonged exposure therapy includes a trauma focused protocol and cognitive behavioral treatment for PTSD. Cognitive behavioral treatment includes psychoeducation, in vivo exposures, and imaginal exposures.
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2: Active Comparator
Participants receiving active psychotherapy
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Procedure: Active Psychotherapy
Active psychotherapy includes non-trauma focused therapy, based on time-limited psychodynamic treatment, which includes a formulation of a central issue and open-associative sessions exploring main conflicts and drives.
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PTSD is an anxiety disorder that can develop after exposure to an event in harm to the life or physical integrity of oneself or others has occurred or was threatened. People with PTSD have persistent frightening thoughts and memories of their ordeal and often feel emotionally numb, especially with people to whom they were once close. Effective treatments for post-traumatic stress disorder are available, and research is yielding new, improved therapies that can help reduce symptoms of PTSD. Prolonged exposure (PE) therapy is a brief cognitive behavioral therapy that has been effective in treating symptoms of PTSD in adults. However, no treatments have been proven effective for the treatment of PTSD in adolescents. This study will compare the effectiveness of PE therapy versus non-trauma directed active psychotherapy in reducing the symptoms of PTSD in adolescents. In addition, this study aims to refine the existing PE treatment protocol for adolescents with PTSD.
Participants in this single-blind study will be randomly assigned to receive either PE therapy or AP. All participants will receive 12 to 18 therapy sessions, which will be conducted weekly. Assessments of PTSD symptoms, depression, and overall functioning will be conducted at baseline, immediately post-treatment, and 3 months post-treatment.
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Schneider Children's Medical Center of Israel | |
Petach Tikvah, Israel, 49202 |
Principal Investigator: | Eva Gilboa-Schechtman, PhD | Bar-Ilan University |
Principal Investigator: | Edna B. Foa, PhD | University of Pennsylvania |
Responsible Party: | Bar-ILan University ( Eva Gilboa-Schechtman ) |
Study ID Numbers: | R34 MH71660, DATR AD-TS |
Study First Received: | September 13, 2005 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00183690 History of Changes |
Health Authority: | United States: Federal Government |
PTSD Anxiety Disorder Trauma Adolescents Cognitive Behavioral Therapy |
Anxiety Disorders Mental Disorders Wounds and Injuries |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease Anxiety Disorders |
Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |