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Trial record 3 of 1900 for:    Diseases | ( Map: Puerto Rico )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01203293
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : August 28, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mildred Vera, 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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Cognitive behavior based therapy Behavioral: Treatment as usual Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Study Start Date : September 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive Behavior Therapy Behavioral: Cognitive behavior based therapy
15-20 individual psychotherapy sessions

Active Comparator: Treatment as usual 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.

Primary Outcome Measures :
  1. Penn State Worry Questionnaire [ Time Frame: Baseline ]
  2. Penn State Worry Questionnaire [ Time Frame: Week 20 ]
  3. Penn State Worry Questionnaire [ Time Frame: Week 28. ]

Secondary Outcome Measures :
  1. SF-36 Social Functioning Scale [ Time Frame: Baseline ]
  2. SF-36 Social Functioning Scale [ Time Frame: Week 20 ]
  3. SF-36 Social Functioning Scale [ Time Frame: Week 28 ]
  4. Quality of Life Inventory [ Time Frame: Baseline ]
  5. Quality of Life Inventory [ Time Frame: Week 20 ]
  6. Quality of Life Inventory [ Time Frame: Week 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01203293

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Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
National Institute of Mental Health (NIMH)

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Responsible Party: Mildred Vera, Professor, University of Puerto Rico Identifier: NCT01203293     History of Changes
Other Study ID Numbers: 5SC1MH90599-2
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Anxiety Disorders
Pathologic Processes
Mental Disorders