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

Phase 1

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Cognitive behavior based therapy; Behavioral: Treatment as usual

• Registration Number: NCT01203293
• Lead Sponsor: University of Puerto Rico

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Therapy	Cognitive behavior based therapy	-
Treatment as usual	Treatment as usual	-

Primary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire	Week 28.

Secondary Outcome Measures

Name	Time	Method
SF-36 Social Functioning Scale	Week 28
Quality of Life Inventory	Week 28

Trial Locations

Locations (1)

University of Puerto Rico, Medical Sciences Campus; 🇵🇷 San Juan, Puerto Rico