Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
|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.|
|ClinicalTrials.gov Identifier: NCT00183690|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Procedure: Prolonged Exposure Therapy Procedure: Active Psychotherapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treating Terror-Related PTSD in Adolescents|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||June 2008|
Participants receiving prolonged exposure therapy
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.
Active Comparator: 2
Participants receiving active psychotherapy
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.
- Symptoms of post-traumatic stress disorder [ Time Frame: Measured at Month 3 ]
- Symptoms of depression [ Time Frame: Measured at Month 3 ]
- Clinical global assessment of overall functioning [ Time Frame: Measured at Month 3 ]
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): NCT00183690
|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|