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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Treating Terror-Related PTSD in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183690
• Other study ID #: R34MH071660
• Secondary ID: DATR AD-TS
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: December 11, 2008
• Start date: September 2004
• Est. completion date: June 2008

Study information

• Verified date: December 2008
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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 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.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikvah

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of post-traumatic stress disorder		Measured at Month 3
Primary	Symptoms of depression		Measured at Month 3
Secondary	Clinical global assessment of overall functioning		Measured at Month 3