Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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The purpose of this project is to examine the feasibility of a culturally adapted, manual based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto Ricans with posttraumatic stress disorder

Detailed Description
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This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of treatments for PTSD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with PTSD and the long-term negative consequences of this condition. Participants in this study are recruited by referral from mental health providers in a general health setting. Patients meeting criteria for enrollment will be randomly assigned to receive either Prolonged Exposure therapy or treatment as usual. Assessments for all participants will be collected at baseline, week 8, and week 16 after randomization.

Official Title
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Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Prolonged Exposure
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of PTSD CAPS score of at least 45 18 to 65 years old Spanish speaker competent to provide informed consent Exclusion Criteria: history of bipolar disease, schizophrenia or psychotic disorder alcohol or drug abuse in the past three months moderate to severe traumatic brain injury applying for or receiving disability benefits clinically judged to have a high acute suicide risk life-threatening medical condition currently receiving psychotherapy for PTSD or changed psychotropic medication within 2 months of randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prolonged Exposure<br> | Behavioral: Prolonged Exposure<br>* 15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories<br>|
| Active Comparator: Usual care<br> | Behavioral: Usual care<br>* Per usual care, patients are referred to a mental health provider within the health care setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale | The Clinician-Administered PTSD Scale is a semi-structured interview designed to assess posttraumatic stress disorder (PTSD) diagnostic status and symptom severity. | Baseline, week 8, week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorder, Prolonged exposure, Cognitive behavior therapy