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Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents

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ClinicalTrials.gov Identifier: NCT00183690
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 12, 2008
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)

Brief Summary:
This study will compare the effectiveness of prolonged exposure therapy versus active psychotherapy in treating post-traumatic stress disorder (PTSD) in adolescents.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Procedure: Prolonged Exposure Therapy Procedure: Active Psychotherapy Phase 1

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Terror-Related PTSD in Adolescents
Study Start Date : September 2004
Primary Completion Date : March 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.



Primary Outcome Measures :
  1. Symptoms of post-traumatic stress disorder [ Time Frame: Measured at Month 3 ]
  2. Symptoms of depression [ Time Frame: Measured at Month 3 ]

Secondary Outcome Measures :
  1. Clinical global assessment of overall functioning [ Time Frame: Measured at Month 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of PTSD
  • In grades 6-12
  • No change in medication regimen for more than 6 weeks

Exclusion Criteria:

  • Diagnosis of ADHD, conduct disorder, thought disorder, or bipolar disorder

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): NCT00183690


Locations
Israel
Schneider Children's Medical Center of Israel
Petach Tikvah, Israel, 49202
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Eva Gilboa-Schechtman, PhD Bar-Ilan University
Principal Investigator: Edna B. Foa, PhD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Gilboa-Schechtman, Bar-ILan University
ClinicalTrials.gov Identifier: NCT00183690     History of Changes
Other Study ID Numbers: R34MH071660 ( U.S. NIH Grant/Contract )
DATR AD-TS
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008

Keywords provided by National Institute of Mental Health (NIMH):
PTSD
Anxiety Disorder
Trauma
Adolescents
Cognitive Behavioral Therapy

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