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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Applied Relaxation; Behavioral: Prolonged Exposure

• Registration Number: NCT02134691
• Lead Sponsor: University of Puerto Rico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Primary Completion: 2018-06-30
• Study Completion: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Applied Relaxation	Applied Relaxation	Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
Prolonged Exposure	Prolonged Exposure	Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.

Primary Outcome Measures

Name	Time	Method
Change in Clinician Administered PTSD Scales (CAPS)	6 months

Secondary Outcome Measures

Name	Time	Method
Change in Sheehan Disability Scale	6 months
Change in SF-12	6 months

Trial Locations

Locations (1)

University of Puerto Rico, Medical Sciences Campus; 🇵🇷 San Juan, Puerto Rico