Collaborative Depression Care Management in Treating Depressed Low-income Hispanics With Diabetes (MDDP)

November 20, 2023 updated by: University of Southern California

Multifaceted Depression Diabetes Program for Hispanics

This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in Hispanics with depression and diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes, a disease in which the body does not properly produce or use insulin, is the fifth leading cause of death among Hispanics in the United States. The risk of comorbid depression among diabetics is twice as high as that of the general population, with depression rates among diabetic Hispanics as high as 33%. Symptoms of depression include feelings of sadness, anxiety, and guilt; lack of energy; changes in appetite; and lack of pleasure in previously enjoyed activities. These symptoms can make maintaining good diabetic management and self-care regimens difficult. Fortunately, depression is treatable with forms of psychotherapy and antidepressant medications. However, depression treatment adherence and response rates among the Hispanic population, especially among Hispanics of low socio-economic status, are lower than those of the general population. Depression treatment that is specifically adapted for the Hispanic culture may be best at helping diabetic Hispanics stick to their treatment and self-care plans. This study will evaluate the effectiveness of culturally adapted depression treatment for reducing depressive symptoms and improving adherence to diabetes self-care regimens in low-income Hispanics with depression and diabetes.

Participation in this study will last 18 months. All participants will first undergo baseline assessments that will include a 40-minute interview about personal health and feelings. Eligible participants will then be assigned randomly to receive either collaborative depression care management or enhanced usual care.

Participants assigned to receive collaborative depression care management will first be provided with information about depression treatment. Participants will then have the option of choosing between two depression treatments: counseling or antidepressant medications. Participants who choose to receive treatment with counseling will receive eight weekly 45-minute counseling sessions, conducted either on the phone or at the clinic. During these sessions, participants will undergo structured problem solving therapy (PST) and will learn strategies to manage their depressive symptoms. Participants who choose to receive treatment with antidepressant medication will be prescribed medication by a study doctor and will be monitored for any side effects throughout treatment. Medication treatment may last up to 12 months but will depend upon participants' severity of depression. After completing medication treatment, participants will be offered PST counseling. All participants receiving collaborative depression care management will also receive supportive patient navigation services and maintenance/relapse telephone monitoring.

Participants assigned to enhanced usual care will receive an educational pamphlet on depression and a list of mental health resources in the community. Participants' primary care doctors will be free to prescribe antidepressant medication or provide other usual care. All participants will undergo follow-up phone interviews about their status at Months 6, 12, and 18.

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089-0411
        • University of Southern California School of Social Work

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets criteria for major depression based on a score of greater than 2 for five or more symptoms, including one of the two cardinal depression symptoms and a nine-item depression scale of the Patient Health Questionnaire (PHQ-9) score of greater than 10
  • Patient with diabetes
  • Has attended two community safety net clinics

Exclusion Criteria:

  • Current suicidal ideation
  • Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
  • Recent use of lithium or antipsychotic medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients will receive collaborative depression care management.
Behavioral: Collaborative depression care management
Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are socio-culturally adaptated for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.
Active Comparator: 2
Patients will receive enhanced usual care.
Behavioral: Enhanced usual care
Participants will receive educational pamphlets on depression and a list of mental health resources in the community. Participants' primary care doctors will be free to prescribe antidepressant medication or provide other usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in symptoms of major depression
Time Frame: Measured at Months 12, 18, and 24
Measured at Months 12, 18, and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Measured at Months 12, 18, and 24
Measured at Months 12, 18, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kathleen R. Ell, DSW, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimated)

July 3, 2008

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH068468 (U.S. NIH Grant/Contract)
  • DSIR 82-SESQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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