Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
Puerto Rico
Study Type
Interventional
Intervention
Cognitive behavior based therapy
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
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
Sites / Locations
- University of Puerto Rico, Medical Sciences Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Behavior Therapy
Treatment as usual
Arm Description
Outcomes
Primary Outcome Measures
Penn State Worry Questionnaire
Penn State Worry Questionnaire
Penn State Worry Questionnaire
Secondary Outcome Measures
SF-36 Social Functioning Scale
SF-36 Social Functioning Scale
SF-36 Social Functioning Scale
Quality of Life Inventory
Quality of Life Inventory
Quality of Life Inventory
Full Information
NCT ID
NCT01203293
First Posted
June 11, 2010
Last Updated
August 26, 2014
Sponsor
University of Puerto Rico
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01203293
Brief Title
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Official Title
CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavior Therapy
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior based therapy
Intervention Description
15-20 individual psychotherapy sessions
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Penn State Worry Questionnaire
Time Frame
Baseline
Title
Penn State Worry Questionnaire
Time Frame
Week 20
Title
Penn State Worry Questionnaire
Time Frame
Week 28.
Secondary Outcome Measure Information:
Title
SF-36 Social Functioning Scale
Time Frame
Baseline
Title
SF-36 Social Functioning Scale
Time Frame
Week 20
Title
SF-36 Social Functioning Scale
Time Frame
Week 28
Title
Quality of Life Inventory
Time Frame
Baseline
Title
Quality of Life Inventory
Time Frame
Week 20
Title
Quality of Life Inventory
Time Frame
Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Puerto Rico, Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
12. IPD Sharing Statement
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Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
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