Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector

August 26, 2014 updated by: Mildred Vera, University of Puerto Rico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico, Medical Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Behavioral: Treatment as usual
Treatment as usual is an active comparator group in which patients are provided referrals to specialty mental health care services or can use any primary or specialty care services available to them in usual care.
Experimental: Cognitive Behavior Therapy
Behavioral: Cognitive behavior based therapy
15-20 individual psychotherapy sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Penn State Worry Questionnaire
Time Frame: Baseline
Baseline
Penn State Worry Questionnaire
Time Frame: Week 20
Week 20
Penn State Worry Questionnaire
Time Frame: Week 28.
Week 28.

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36 Social Functioning Scale
Time Frame: Baseline
Baseline
SF-36 Social Functioning Scale
Time Frame: Week 20
Week 20
SF-36 Social Functioning Scale
Time Frame: Week 28
Week 28
Quality of Life Inventory
Time Frame: Baseline
Baseline
Quality of Life Inventory
Time Frame: Week 20
Week 20
Quality of Life Inventory
Time Frame: Week 28
Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5SC1MH90599-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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