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Clinical Trials/NCT01203293
NCT01203293
Completed
Phase 1

CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector

University of Puerto Rico1 site in 1 country90 target enrollmentSeptember 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
University of Puerto Rico
Enrollment
90
Locations
1
Primary Endpoint
Penn State Worry Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.

Detailed Description

This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of CBT based treatments for GAD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with GAD and the long-term negative consequences of this condition. Participants in this study are recruited in general health settings. Patients meeting criteria for enrollment will be randomly assigned to receive either cognitive behavior based therapy or treatment as usual. Assessments for all participants will be collected at baseline, post-treatment, and at two months follow-up visits.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mildred Vera

Professor

University of Puerto Rico

Eligibility Criteria

Inclusion Criteria

  • diagnosis of GAD
  • 18 to 65 years
  • Spanish speaker
  • able to read and write
  • plan to continue receiving services in the health care setting during the next six months

Exclusion Criteria

  • severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence
  • clinically judged to have a high acute suicide risk
  • life-threatening medical condition
  • currently receiving psychotherapy

Outcomes

Primary Outcomes

Penn State Worry Questionnaire

Time Frame: Week 28.

Secondary Outcomes

  • SF-36 Social Functioning Scale(Week 28)
  • Quality of Life Inventory(Week 28)

Study Sites (1)

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