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

U

University of Puerto Rico (UPR)

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Prolonged Exposure
Behavioral: Applied Relaxation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02134691
SC1MH090599

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

Prolonged Exposure
Experimental group
Description:
Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.
Treatment:
Behavioral: Prolonged Exposure
Applied Relaxation
Active Comparator group
Description:
Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
Treatment:
Behavioral: Applied Relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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