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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Active Psychotherapy
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Anxiety Disorder, Trauma, Adolescents, Cognitive Behavioral Therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Schneider Children's Medical Center of Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants receiving prolonged exposure therapy

Participants receiving active psychotherapy

Outcomes

Primary Outcome Measures

Symptoms of post-traumatic stress disorder
Symptoms of depression

Secondary Outcome Measures

Clinical global assessment of overall functioning

Full Information

First Posted
September 13, 2005
Last Updated
December 11, 2008
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183690
Brief Title
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
Official Title
Treating Terror-Related PTSD in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Anxiety Disorder, Trauma, Adolescents, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants receiving prolonged exposure therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants receiving active psychotherapy
Intervention Type
Procedure
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
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
Intervention Name(s)
Active Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of post-traumatic stress disorder
Time Frame
Measured at Month 3
Title
Symptoms of depression
Time Frame
Measured at Month 3
Secondary Outcome Measure Information:
Title
Clinical global assessment of overall functioning
Time Frame
Measured at Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Gilboa-Schechtman, PhD
Organizational Affiliation
Bar-Ilan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edna B. Foa, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikvah
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20855048
Citation
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. Erratum In: J Am Acad Child Adolesc Psychiatry. 2016 Oct;55(10):920.
Results Reference
derived

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

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