search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Collaborative depression care management
Enhanced usual care
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Major Depression, Diabetes, Hispanics, Collaborative Depression Care Management

Eligibility Criteria

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

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

Sites / Locations

  • University of Southern California School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Patients will receive collaborative depression care management.

Patients will receive enhanced usual care.

Outcomes

Primary Outcome Measures

Reduction in symptoms of major depression

Secondary Outcome Measures

Quality of life

Full Information

First Posted
June 30, 2008
Last Updated
July 25, 2013
Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00709150
Brief Title
Collaborative Depression Care Management in Treating Depressed Low-income Hispanics With Diabetes
Acronym
MDDP
Official Title
Multifaceted Depression Diabetes Program for Hispanics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depression, Diabetes, Hispanics, Collaborative Depression Care Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
387 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive collaborative depression care management.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will receive enhanced usual care.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative depression care management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in symptoms of major depression
Time Frame
Measured at Months 12, 18, and 24
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Measured at Months 12, 18, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R. Ell, DSW
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California School of Social Work
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-0411
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22458987
Citation
Ell K, Katon W, Lee PJ, Kapetanovic S, Guterman J, Xie B, Chou CP. Depressive symptom deterioration among predominantly Hispanic diabetes patients in safety net care. Psychosomatics. 2012 Jul-Aug;53(4):347-55. doi: 10.1016/j.psym.2011.12.009. Epub 2012 Mar 27.
Results Reference
derived
PubMed Identifier
22433755
Citation
Hay JW, Katon WJ, Ell K, Lee PJ, Guterman JJ. Cost-effectiveness analysis of collaborative care management of major depression among low-income, predominantly Hispanics with diabetes. Value Health. 2012 Mar-Apr;15(2):249-54. doi: 10.1016/j.jval.2011.09.008. Epub 2011 Dec 15.
Results Reference
derived
PubMed Identifier
21774987
Citation
Ell K, Katon W, Xie B, Lee PJ, Kapetanovic S, Guterman J, Chou CP. One-year postcollaborative depression care trial outcomes among predominantly Hispanic diabetes safety net patients. Gen Hosp Psychiatry. 2011 Sep-Oct;33(5):436-42. doi: 10.1016/j.genhosppsych.2011.05.018. Epub 2011 Jul 19.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs