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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Puerto Rico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Puerto Rico
ClinicalTrials.gov Identifier:
NCT01203293
First received: June 11, 2010
Last updated: September 15, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: Cognitive behavior based therapy
Behavioral: Treatment as usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector

Resource links provided by NLM:


Further study details as provided by University of Puerto Rico:

Primary Outcome Measures:
  • Penn State Worry Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: Week 28. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 Social Functioning Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • SF-36 Social Functioning Scale [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • SF-36 Social Functioning Scale [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: September 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Intervention Behavioral: Cognitive behavior based therapy
15-20 individual psychotherapy sessions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203293

Contacts
Contact: Mildred Vera, Ph.D. 787-758-3189 mildred.vera@upr.edu
Contact: Deborah Juarbe, Ph.D. 787-758-2525 ext 2053 deborah.juarbe1@upr.edu

Locations
Puerto Rico
University of Puerto Rico, Medical Sciences Campus Recruiting
San Juan, Puerto Rico, 00936
Contact: Mildred Vera, Ph.D.    787-758-3189    mildred.vera@upr.edu   
Principal Investigator: Mildred Vera, Ph.D.         
Sponsors and Collaborators
University of Puerto Rico
  More Information

No publications provided

Responsible Party: Mildred Vera, PhD, University of Puerto Rico, Medical Sciences Campus
ClinicalTrials.gov Identifier: NCT01203293     History of Changes
Other Study ID Numbers: 5SC1MH90599-2
Study First Received: June 11, 2010
Last Updated: September 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014