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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134691
Enrollment
98
Registered
2014-05-09
Start date
2013-08-31
Completion date
2019-02-28
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder (PTSD), Prolonged Exposure (PE)

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.

Interventions

BEHAVIORALProlonged Exposure

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Puerto Rico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Clinician Administered PTSD Scales (CAPS)6 months

Secondary

MeasureTime frame
Change in SF-126 months
Change in Sheehan Disability Scale6 months

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026