Clinical trial NCT00797901: Depression Treatment in General Medical Settings
Official title: Depression Treatment in General Medical Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2008-11-25
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
measure: Depression
timeFrame: 2 months
measure: Health-Related Functional Impairment
timeFrame: 2 months
measure: Quality of Life
timeFrame: 2 months
Secondary outcomes:
measure: Satisfaction with Care
timeFrame: 2 months
measure: Barriers to Treatment
timeFrame: 2 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: University of Puerto Rico
name: Mildred Vera, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Deborah Juarbe, Ph.D.
role: STUDY_DIRECTOR
References: