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OpenTrials
Completed

NCT Number: NCT02134691

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Exposure

Behavioral

Applied Relaxation

Behavioral

Primary outcomes

  1. Change in Clinician Administered PTSD Scales (CAPS)

    Time frame: 6 months

Secondary outcomes

  1. Change in SF-12

    Time frame: 6 months

  2. Change in Sheehan Disability Scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
May 9, 2014
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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