NCT00183690

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 12, 2008

Status Verified

December 1, 2008

Enrollment Period

3.5 years

First QC Date

September 13, 2005

Last Update Submit

December 11, 2008

Conditions

Keywords

PTSDAnxiety DisorderTraumaAdolescentsCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

  • Symptoms of post-traumatic stress disorder

    Measured at Month 3

  • Symptoms of depression

    Measured at Month 3

Secondary Outcomes (1)

  • Clinical global assessment of overall functioning

    Measured at Month 3

Study Arms (2)

1

EXPERIMENTAL

Participants receiving prolonged exposure therapy

Procedure: Prolonged Exposure Therapy

2

ACTIVE COMPARATOR

Participants receiving active psychotherapy

Procedure: Active Psychotherapy

Interventions

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.

1

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.

2

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary diagnosis of PTSD
  • In grades 6-12
  • No change in medication regimen for more than 6 weeks

You may not qualify if:

  • Diagnosis of ADHD, conduct disorder, thought disorder, or bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petach Tikvah, 49202, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Eva Gilboa-Schechtman, PhD

    Bar Ilan University

    PRINCIPAL INVESTIGATOR
  • Edna B. Foa, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2004

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

December 12, 2008

Record last verified: 2008-12

Locations