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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive behavior based therapy
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy<br> | Behavioral: Cognitive behavior based therapy<br>* 15-20 individual psychotherapy sessions<br>|
| Active Comparator: Treatment as usual<br> | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn State Worry Questionnaire |  | Baseline | 
| Penn State Worry Questionnaire |  | Week 20 | 
| Penn State Worry Questionnaire |  | Week 28. | 

Secondary Outcome Measures

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