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Clinical Trials/NCT00183690
NCT00183690
Completed
Phase 1

Treating Terror-Related PTSD in Adolescents

National Institute of Mental Health (NIMH)1 site in 1 country60 target enrollmentSeptember 2004

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder
Sponsor
National Institute of Mental Health (NIMH)
Enrollment
60
Locations
1
Primary Endpoint
Symptoms of post-traumatic stress disorder
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
June 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Symptoms of post-traumatic stress disorder

Time Frame: Measured at Month 3

Symptoms of depression

Time Frame: Measured at Month 3

Secondary Outcomes

  • Clinical global assessment of overall functioning(Measured at Month 3)

Study Sites (1)

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