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Depression Treatment in General Medical Settings

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Collaborative Care
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Puerto Rico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collaborative Care, Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

Depression
Health-Related Functional Impairment
Quality of Life

Secondary Outcome Measures

Satisfaction with Care
Barriers to Treatment

Full Information

First Posted
November 24, 2008
Last Updated
August 26, 2014
Sponsor
University of Puerto Rico
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00797901
Brief Title
Depression Treatment in General Medical Settings
Official Title
Depression Treatment in General Medical Settings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care, Treatment as Usual
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Collaborative Care
Primary Outcome Measure Information:
Title
Depression
Time Frame
2 months
Title
Health-Related Functional Impairment
Time Frame
2 months
Title
Quality of Life
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Satisfaction with Care
Time Frame
2 months
Title
Barriers to Treatment
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mildred Vera, Ph.D.
Organizational Affiliation
University of Puerto Rico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Juarbe, Ph.D.
Organizational Affiliation
University of Puerto Rico
Official's Role
Study Director
Facility Information:
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

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Depression Treatment in General Medical Settings

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