Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Prolonged Exposure; Behavioral: Usual care

• Registration Number: NCT01306136
• Lead Sponsor: University of Puerto Rico

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 Timeline

• Study Start: 2008-11
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Status Verified: 2011-02
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Last Update Submitted: 2011-02-28
• Study First Posted: 2011-03-01
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure	Prolonged Exposure	-
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale	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.

Trial Locations

Locations (1)

University of Puerto Rico, Medical Sciences Campus; 🇵🇷 San Juan, Puerto Rico