Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

February 28, 2011 updated by: University of Puerto Rico

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

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico, Medical Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Per usual care, patients are referred to a mental health provider within the health care setting.
Experimental: Prolonged Exposure
15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Administered PTSD Scale
Time Frame: Baseline, week 8, week 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

February 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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