Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder

NCT ID: NCT01306136

Last Updated: 2011-03-01

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

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

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

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Per usual care, patients are referred to a mental health provider within the health care setting.

Interventions

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Prolonged Exposure

15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories

Intervention Type BEHAVIORAL

Usual care

Per usual care, patients are referred to a mental health provider within the health care setting.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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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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1300209

Identifier Type: -

Identifier Source: org_study_id

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