Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)

April 15, 2019 updated by: Mildred Vera, University of Puerto Rico
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

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

  • Puerto Rico
      • 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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to < 65 years
  • Meet diagnostic criteria for PTSD
  • Spanish speaker
  • Allow recording of assessments and therapy

Exclusion Criteria:

  • Significant current suicidal or homicidal ideation
  • History of bipolar, schizophrenia or psychotic disorder
  • Alcohol or drug abuse during the past three months
  • Current high risk of being assaulted (i.e., living with domestic violence)
  • Current psychotherapy to treat PTSD
  • Unable to provide informed consent

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
Experimental: Prolonged Exposure
Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.
Behavioral: Prolonged Exposure
Active Comparator: Applied Relaxation
Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
Behavioral: Applied Relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Clinician Administered PTSD Scales (CAPS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in SF-12
Time Frame: 6 months
6 months
Change in Sheehan Disability Scale
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

University of Puerto Rico

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mildred Vera, Ph.D, University of Puerto Rico Medical Sciences Campus

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

August 1, 2013

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC1MH090599 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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