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

Study Overview
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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.

Official Title
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Treating Terror-Related PTSD in Adolescents

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Procedure: Prolonged Exposure Therapy
* Procedure: Active Psychotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants receiving prolonged exposure therapy | Procedure: Prolonged Exposure Therapy<br>* 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.<br>|
| Active Comparator: 2<br>Participants receiving active psychotherapy | Procedure: Active Psychotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of post-traumatic stress disorder |  | Measured at Month 3 | 
| Symptoms of depression |  | Measured at Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical global assessment of overall functioning |  | Measured at Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Anxiety Disorder, Trauma, Adolescents, Cognitive Behavioral Therapy