Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorder |
Behavioral: Prolonged Exposure Behavioral: Usual care |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder |
- 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.
| Enrollment: | 14 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Prolonged Exposure |
Behavioral: Prolonged Exposure
15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
|
| Active Comparator: Usual care |
Behavioral: Usual care
Per usual care, patients are referred to a mental health provider within the health care setting.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mildred Vera, University of Puerto Rico, Medical Sciences Campus |
| ClinicalTrials.gov Identifier: | NCT01306136 History of Changes |
| Other Study ID Numbers: | 1300209 |
| Study First Received: | February 28, 2011 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Puerto Rico:
|
Posttraumatic stress disorder Prolonged exposure Cognitive behavior therapy |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013