Back to resultsPilot Study of Exposure Therapy for Posttraumatic Stress Disorder
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
Puerto Rico
Study Type
Interventional
Intervention
Prolonged Exposure
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic stress disorder, Prolonged exposure, Cognitive behavior therapy
Eligibility Criteria
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
Sites / Locations
- University of Puerto Rico, Medical Sciences Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged Exposure
Usual care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01306136
First Posted
February 28, 2011
Last Updated
February 28, 2011
Sponsor
University of Puerto Rico
1. Study Identification
Unique Protocol Identification Number
NCT01306136
Brief Title
Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
Official Title
Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Puerto Rico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic stress disorder, Prolonged exposure, Cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Exposure
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Description
15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Per usual care, patients are referred to a mental health provider within the health care setting.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale
Description
The Clinician-Administered PTSD Scale is a semi-structured interview designed to assess posttraumatic stress disorder (PTSD) diagnostic status and symptom severity.
Time Frame
Baseline, week 8, week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Puerto Rico, Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
12. IPD Sharing Statement
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Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
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