Skip to main content
OpenTrials
Completed

NCT Number: NCT01306136

Pilot Study of Exposure Therapy for 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Exposure

Behavioral

15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories

Usual Care

Behavioral

Per usual care, patients are referred to a mental health provider within the health care setting.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 1, 2011
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.