Depression Treatment in General Medical Settings

Major Depression Clinical Trial

Official title:

Depression Treatment in General Medical Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797901
• Other study ID #: S06GM008224
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: August 26, 2014
• Start date: August 2004
• Est. completion date: April 2008

Study information

• Verified date: August 2014
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Other:
• Collaborative Care

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression		2 months	No
Primary	Health-Related Functional Impairment		2 months	No
Primary	Quality of Life		2 months	No
Secondary	Satisfaction with Care		2 months	No
Secondary	Barriers to Treatment		2 months	No