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

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ClinicalTrials.gov Identifier: NCT02134691
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mildred Vera, University of Puerto Rico

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Change in Clinician Administered PTSD Scales (CAPS) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Change in SF-12 [ Time Frame: 6 months ]
  • Change in Sheehan Disability Scale [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • Behavioral: Prolonged Exposure
  • Behavioral: Applied Relaxation
Study Arms  ICMJE
  • Experimental: Prolonged Exposure
    Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program.
    Intervention: Behavioral: Prolonged Exposure
  • Active Comparator: Applied Relaxation
    Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program.
    Intervention: Behavioral: Applied Relaxation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2018)
98
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
100
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134691
Other Study ID Numbers  ICMJE SC1MH090599( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mildred Vera, University of Puerto Rico
Study Sponsor  ICMJE University of Puerto Rico
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Mildred Vera, Ph.D University of Puerto Rico Medical Sciences Campus
PRS Account University of Puerto Rico
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP