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

NCT ID: NCT00183690

Last Updated: 2008-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder

Keywords

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PTSD Anxiety Disorder Trauma Adolescents Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants receiving prolonged exposure therapy

Group Type EXPERIMENTAL

Prolonged Exposure Therapy

Intervention Type PROCEDURE

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.

2

Participants receiving active psychotherapy

Group Type ACTIVE_COMPARATOR

Active Psychotherapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role lead

Responsible Party

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Bar-ILan University

Principal Investigators

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Eva Gilboa-Schechtman, PhD

Role: PRINCIPAL_INVESTIGATOR

Bar Ilan University

Edna B. Foa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Schneider Children's Medical Center of Israel

Petach Tikvah, , Israel

Site Status

Countries

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Israel

References

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Gilboa-Schechtman E, Foa EB, Shafran N, Aderka IM, Powers MB, Rachamim L, Rosenbach L, Yadin E, Apter A. Prolonged exposure versus dynamic therapy for adolescent PTSD: a pilot randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1034-42. doi: 10.1016/j.jaac.2010.07.014. Epub 2010 Sep 6.

Reference Type DERIVED
PMID: 20855048 (View on PubMed)

Other Identifiers

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DATR AD-TS

Identifier Type: -

Identifier Source: secondary_id

R34MH071660

Identifier Type: NIH

Identifier Source: org_study_id

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