Clinical trial NCT00183690: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Anxiety Disorder
Trauma
Adolescents
Cognitive Behavioral Therapy
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptoms of post-traumatic stress disorder
timeFrame: Measured at Month 3
measure: Symptoms of depression
timeFrame: Measured at Month 3
Secondary outcomes:
measure: Clinical global assessment of overall functioning
timeFrame: Measured at Month 3
Other outcomes:
Locations:
city: Petach Tikvah
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Bar Ilan University
name: Eva Gilboa-Schechtman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Edna B. Foa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.