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Depression Treatment in General Medical Settings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797901
First Posted: November 25, 2008
Last Update Posted: August 28, 2014
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.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mildred Vera, University of Puerto Rico
  Purpose
The purpose of this study was to examine the effect of a new disease management model for depression, the Collaborative Depression Management Program (CDMP), designed to improve clinical outcomes and increase depression treatment in general medical settings.

Condition Intervention
Major Depression Other: Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Depression Treatment in General Medical Settings

Further study details as provided by Mildred Vera, University of Puerto Rico:

Primary Outcome Measures:
  • Depression [ Time Frame: 2 months ]
  • Health-Related Functional Impairment [ Time Frame: 2 months ]
  • Quality of Life [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Satisfaction with Care [ Time Frame: 2 months ]
  • Barriers to Treatment [ Time Frame: 2 months ]

Enrollment: 179
Study Start Date: August 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Care, Treatment as Usual Other: Collaborative Care

Detailed Description:

Clinically depressed individuals that could benefit from newer treatments for depression often do not receive care. Low treatment rates are of particular concern since depression is projected to be the second leading cause of disability worldwide by 2010. Major depression has been the focus of numerous intervention studies with primary care patients during recent years. However, despite advances in the development and testing of quality intervention models for depression treatment, very little is known about the effectiveness of interventions with Latinos. This is important because Latinos are less likely than whites to receive depression treatment, even though the rates of depression are similar for both groups. A major public health challenge is to make available the benefits of intervention developments in depression treatment for all groups in society. As a first step, we examined the impact of a quality depression intervention with Puerto Ricans. The specific aims were:

  1. To examine the effect of a Collaborative Depression Management Program in reducing depressive symptoms, improving quality of life, and decreasing health-related functional impairment among Puerto Rican patients in general medical settings.
  2. To determine whether a Collaborative Depression Management Program is effective in improving satisfaction with care and reducing barriers to depression treatment among Puerto Rican patients in general medical settings.

This study employed a randomized experimental design. Depressed patients receiving general medical care were assigned to one of two conditions: 80 to the Depression Management Program and 80 to treatment as usual. All subjects completed assessments at baseline, week 8, week 16 and week 24. Our overall programmatic goals were to increase the likelihood that depressed patients receive care and to make available for the Puerto Rican community advances in the treatment of major depression.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients ages 18 or older that meet the clinical criteria for major depression.

Exclusion Criteria:

  • pregnancy, planning a pregnancy, breastfeeding or less than 3 months post-partum
  • severe cognitive impairment
  • ongoing psychiatric treatment
  • do not plan to use the study clinic as a main source of medical care during the next six months
  • a history of bipolar disorder or psychosis
  • those clinically judged to have a high acute suicidal risk
  • unstable or life-threatening medical condition
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00797901


Locations
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Mildred Vera, Ph.D. University of Puerto Rico
Study Director: Deborah Juarbe, Ph.D. University of Puerto Rico
  More Information

Responsible Party: Mildred Vera, Ph.D., University of Puerto Rico
ClinicalTrials.gov Identifier: NCT00797901     History of Changes
Other Study ID Numbers: S06GM008224 ( U.S. NIH Grant/Contract )
First Submitted: November 24, 2008
First Posted: November 25, 2008
Last Update Posted: August 28, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders