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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183690
First received: September 13, 2005
Last updated: December 11, 2008
Last verified: December 2008
History of Changes
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Terror-Related PTSD in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Symptoms of post-traumatic stress disorder [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Symptoms of depression [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical global assessment of overall functioning [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

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
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional 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: R34 MH71660, DATR AD-TS
Study First Received: September 13, 2005
Last Updated: December 11, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013