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

NCT ID: NCT01203293

Last Updated: 2014-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-02-28

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavior Therapy

Group Type: EXPERIMENTAL

Cognitive behavior based therapy

Intervention Type: BEHAVIORAL

15-20 individual psychotherapy sessions

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive behavior based therapy

15-20 individual psychotherapy sessions

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Mildred Vera

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Puerto Rico, Medical Sciences Campus

San Juan, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

5SC1MH090599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5SC1MH90599-2

Identifier Type: -

Identifier Source: org_study_id