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Completed

NCT Number: NCT01203293

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavior based therapy

Behavioral

15-20 individual psychotherapy sessions

Treatment as Usual

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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