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

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. Identifier: NCT02134691
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : April 17, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mildred Vera, University of Puerto Rico

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Prolonged Exposure Behavioral: Applied Relaxation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change in Clinician Administered PTSD Scales (CAPS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in SF-12 [ Time Frame: 6 months ]
  2. Change in Sheehan Disability Scale [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02134691

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Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
National Institute of Mental Health (NIMH)
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Principal Investigator: Mildred Vera, Ph.D University of Puerto Rico Medical Sciences Campus
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Responsible Party: Mildred Vera, Professor, University of Puerto Rico Identifier: NCT02134691    
Other Study ID Numbers: SC1MH090599 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Mildred Vera, University of Puerto Rico:
Posttraumatic Stress Disorder (PTSD)
Prolonged Exposure (PE)
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders