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

Phase 1

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Procedure: Prolonged Exposure Therapy; Procedure: Active Psychotherapy

• Registration Number: NCT00183690
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-11
• Last Update Posted: 2008-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prolonged Exposure Therapy	Participants receiving prolonged exposure therapy
2	Active Psychotherapy	Participants receiving active psychotherapy

Primary Outcome Measures

Name	Time	Method
Symptoms of post-traumatic stress disorder	Measured at Month 3
Symptoms of depression	Measured at Month 3

Secondary Outcome Measures

Name	Time	Method
Clinical global assessment of overall functioning	Measured at Month 3

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikvah, Israel