Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedApril 17, 2019
April 1, 2019
4.9 years
May 7, 2014
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Clinician Administered PTSD Scales (CAPS)
6 months
Secondary Outcomes (2)
Change in SF-12
6 months
Change in Sheehan Disability Scale
6 months
Study Arms (2)
Prolonged Exposure
EXPERIMENTALBehavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.
Applied Relaxation
ACTIVE COMPARATORBehavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
Interventions
Eligibility Criteria
You may qualify if:
- to \< 65 years
- Meet diagnostic criteria for PTSD
- Spanish speaker
- Allow recording of assessments and therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mildred Vera, Ph.D
University of Puerto Rico Medical Sciences Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 9, 2014
Study Start
August 1, 2013
Primary Completion
June 30, 2018
Study Completion
February 28, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04