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Depression Treatment in General Medical Settings

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mildred Vera, University of Puerto Rico
ClinicalTrials.gov Identifier:
NCT00797901
First received: November 24, 2008
Last updated: August 26, 2014
Last verified: August 2014

November 24, 2008
August 26, 2014
August 2004
April 2008   (final data collection date for primary outcome measure)
  • Depression [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Health-Related Functional Impairment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797901 on ClinicalTrials.gov Archive Site
  • Satisfaction with Care [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Barriers to Treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Depression Treatment in General Medical Settings
Depression Treatment in General Medical Settings

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Major Depression
Other: Collaborative Care
Experimental: Collaborative Care, Treatment as Usual
Intervention: Other: Collaborative Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00797901
S06-GM08224
Yes
Mildred Vera, University of Puerto Rico
University of Puerto Rico
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Mildred Vera, Ph.D. University of Puerto Rico
Study Director: Deborah Juarbe, Ph.D. University of Puerto Rico
University of Puerto Rico
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP