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

Sponsor

National Institute of Mental Health (NIMH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00183690

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2004

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Symptoms of post-traumatic stress disorder [Measured at Month 3]
Symptoms of depression [Measured at Month 3]

Secondary Outcome Measures

Clinical global assessment of overall functioning [Measured at Month 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00183690

Other Study ID Numbers:

R34MH071660
DATR AD-TS

First Posted:

Sep 16, 2005

Last Update Posted:

Dec 12, 2008

Last Verified:

Dec 1, 2008

Keywords provided by , ,

Cognitive Behavioral Therapy

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Dec 12, 2008