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Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306136
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Puerto Rico
  Purpose
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

Condition Intervention Phase
Posttraumatic Stress Disorder Behavioral: Prolonged Exposure Behavioral: Usual care Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by University of Puerto Rico:

Primary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prolonged Exposure Behavioral: Prolonged Exposure
15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
Active Comparator: Usual care Behavioral: Usual care
Per usual care, patients are referred to a mental health provider within the health care setting.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306136


Locations
Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
  More Information

Responsible Party: Mildred Vera, University of Puerto Rico, Medical Sciences Campus
ClinicalTrials.gov Identifier: NCT01306136     History of Changes
Other Study ID Numbers: 1300209
First Submitted: February 28, 2011
First Posted: March 1, 2011
Last Update Posted: March 1, 2011
Last Verified: February 2011

Keywords provided by University of Puerto Rico:
Posttraumatic stress disorder
Prolonged exposure
Cognitive behavior therapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders