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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Collaborative Care, Treatment as Usual	Other: Collaborative Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depression	2 months
Health-Related Functional Impairment	2 months
Quality of Life	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Satisfaction with Care	2 months
Barriers to Treatment	2 months

Collaborators and Investigators

• Sponsor: University of Puerto Rico
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (ESTIMATE): November 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: S06GM008224 (NIH)