NCT01306136

Brief Summary

The purpose of this project is to examine the feasibility of a culturally adapted, manual based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto Ricans with posttraumatic stress disorder

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

February 28, 2011

Last Update Submit

February 28, 2011

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic stress disorderProlonged exposureCognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale

    The Clinician-Administered PTSD Scale is a semi-structured interview designed to assess posttraumatic stress disorder (PTSD) diagnostic status and symptom severity.

    Baseline, week 8, week 16

Study Arms (2)

Prolonged Exposure

EXPERIMENTAL
Behavioral: Prolonged Exposure

Usual care

ACTIVE COMPARATOR
Behavioral: Usual care

Interventions

Prolonged ExposureBEHAVIORAL

15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories

Prolonged Exposure
Usual careBEHAVIORAL

Per usual care, patients are referred to a mental health provider within the health care setting.

Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of PTSD
  • CAPS score of at least 45
  • to 65 years old
  • Spanish speaker
  • competent to provide informed consent

You may not qualify if:

  • history of bipolar disease, schizophrenia or psychotic disorder
  • alcohol or drug abuse in the past three months
  • moderate to severe traumatic brain injury
  • applying for or receiving disability benefits
  • clinically judged to have a high acute suicide risk
  • life-threatening medical condition
  • currently receiving psychotherapy for PTSD or changed psychotropic medication within 2 months of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

November 1, 2008

Primary Completion

March 1, 2010

Study Completion

October 1, 2010

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

PR(1)