- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306136
Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
February 28, 2011 updated by: University of Puerto Rico
Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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San Juan, Puerto Rico, 00936
- University of Puerto Rico, Medical Sciences Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
Per usual care, patients are referred to a mental health provider within the health care setting.
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Experimental: Prolonged Exposure
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15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale
Time Frame: 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.
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Baseline, week 8, week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
February 28, 2011
First Submitted That Met QC Criteria
February 28, 2011
First Posted (Estimate)
March 1, 2011
Study Record Updates
Last Update Posted (Estimate)
March 1, 2011
Last Update Submitted That Met QC Criteria
February 28, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1300209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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