Randomized Trial of Prolonged Exposure for the Treatment... | NCT02134691

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

NCT02134691

Sponsor

University of Puerto Rico

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

98Actual

Phase

Not Applicable

Conditions

Posttraumatic Stress Disorder

Interventions

Prolonged Exposure
Applied Relaxation

Countries

Puerto Rico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

May 7, 2014

First Submission Date that Met QC Criteria

May 8, 2014

First Posted Date

May 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonged Exposure	Behavioral		Prolonged Exposure
Applied Relaxation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Clinician Administered PTSD Scales (CAPS)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in SF-12		6 months
Change in Sheehan Disability Scale		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mildred Vera, Ph.D	University of Puerto Rico Medical Sciences Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Puerto Rico, Medical Sciences Campus		San Juan		00936	Puerto Rico

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided