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

NCT ID: NCT02134691

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prolonged Exposure

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

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

Applied Relaxation

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

Group Type ACTIVE_COMPARATOR

Applied Relaxation

Intervention Type BEHAVIORAL

Interventions

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Prolonged Exposure

Intervention Type BEHAVIORAL

Applied Relaxation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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Mildred Vera

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mildred Vera, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico Medical Sciences Campus

Locations

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University of Puerto Rico, Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

Other Identifiers

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SC1MH090599

Identifier Type: NIH

Identifier Source: org_study_id

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