Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306136
• Other study ID #: 1300209
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2011
• Last updated: February 28, 2011
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure
15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
• Usual care
Per usual care, patients are referred to a mental health provider within the health care setting.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale	The Clinician-Administered PTSD Scale is a semi-structured interview designed to assess posttraumatic stress disorder (PTSD) diagnostic status and symptom severity.	Baseline, week 8, week 16	No