Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

This study has been completed.

Sponsor:

Information provided by:

University of Puerto Rico

ClinicalTrials.gov Identifier:

NCT01306136

First received: February 28, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 28, 2011
Last Updated Date	February 28, 2011
Start Date ^ICMJE	November 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 28, 2011)	Clinician-Administered PTSD Scale [ Time Frame: Baseline, week 8, week 16 ] [ Designated as safety issue: No ] The Clinician-Administered PTSD Scale is a semi-structured interview designed to assess posttraumatic stress disorder (PTSD) diagnostic status and symptom severity.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
Official Title ^ICMJE	Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder
Brief Summary	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
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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Posttraumatic Stress Disorder
Intervention ^ICMJE	Behavioral: Prolonged Exposure 15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories Behavioral: Usual care Per usual care, patients are referred to a mental health provider within the health care setting.
Study Arm (s)	Experimental: Prolonged Exposure Intervention: Behavioral: Prolonged Exposure Active Comparator: Usual care Intervention: Behavioral: Usual care
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	14
Completion Date	October 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Puerto Rico

Administrative Information
NCT Number ^ICMJE	NCT01306136
Other Study ID Numbers ^ICMJE	1300209
Has Data Monitoring Committee	No
Responsible Party	Mildred Vera, University of Puerto Rico, Medical Sciences Campus
Study Sponsor ^ICMJE	University of Puerto Rico
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Puerto Rico
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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