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Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Prolonged Exposure
Applied Relaxation
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder (PTSD), Prolonged Exposure (PE)

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to < 65 years
  • Meet diagnostic criteria for PTSD
  • Spanish speaker
  • Allow recording of assessments and therapy

Exclusion Criteria:

  • Significant current suicidal or homicidal ideation
  • History of bipolar, schizophrenia or psychotic disorder
  • Alcohol or drug abuse during the past three months
  • Current high risk of being assaulted (i.e., living with domestic violence)
  • Current psychotherapy to treat PTSD
  • Unable to provide informed consent

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

Applied Relaxation

Arm Description

Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.

Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.

Outcomes

Primary Outcome Measures

Change in Clinician Administered PTSD Scales (CAPS)

Secondary Outcome Measures

Change in SF-12
Change in Sheehan Disability Scale

Full Information

First Posted
May 7, 2014
Last Updated
April 15, 2019
Sponsor
University of Puerto Rico
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02134691
Brief Title
Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.

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 (PTSD), Prolonged Exposure (PE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure
Arm Type
Experimental
Arm Description
Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.
Arm Title
Applied Relaxation
Arm Type
Active Comparator
Arm Description
Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Type
Behavioral
Intervention Name(s)
Applied Relaxation
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scales (CAPS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in SF-12
Time Frame
6 months
Title
Change in Sheehan Disability Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to < 65 years Meet diagnostic criteria for PTSD Spanish speaker Allow recording of assessments and therapy Exclusion Criteria: Significant current suicidal or homicidal ideation History of bipolar, schizophrenia or psychotic disorder Alcohol or drug abuse during the past three months Current high risk of being assaulted (i.e., living with domestic violence) Current psychotherapy to treat PTSD Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mildred Vera, Ph.D
Organizational Affiliation
University of Puerto Rico Medical Sciences Campus
Official's Role
Principal Investigator
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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Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)

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