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NCT02134691 Clinical Trial

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

Posttraumatic Stress Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02134691
Other study ID # SC1MH090599
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date February 28, 2019

Study information
Verified date April 2019
Source University of Puerto Rico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date February 28, 2019
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Prolonged Exposure

• Applied Relaxation

Locations
Country Name City State
Puerto Rico University of Puerto Rico, Medical Sciences Campus San Juan

Sponsors (2)
Lead Sponsor Collaborator
University of Puerto Rico National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Clinician Administered PTSD Scales (CAPS) 6 months
Secondary Change in SF-12 6 months
Secondary Change in Sheehan Disability Scale 6 months
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