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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203293
• Other study ID #: 5SC1MH90599-2
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2010
• Last updated: August 26, 2014
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Cognitive behavior based therapy
15-20 individual psychotherapy sessions
• 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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn State Worry Questionnaire		Baseline	No
Primary	Penn State Worry Questionnaire		Week 20	No
Primary	Penn State Worry Questionnaire		Week 28.	No
Secondary	SF-36 Social Functioning Scale		Baseline	No
Secondary	SF-36 Social Functioning Scale		Week 20	No
Secondary	SF-36 Social Functioning Scale		Week 28	No
Secondary	Quality of Life Inventory		Baseline	No
Secondary	Quality of Life Inventory		Week 20	No
Secondary	Quality of Life Inventory		Week 28	No