Collaborative Depression Care Management in Treating Depressed Low-income Hispanics With Diabetes (MDDP)
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|ClinicalTrials.gov Identifier: NCT00709150|
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : July 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Collaborative depression care management Behavioral: Enhanced usual care||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||387 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Multifaceted Depression Diabetes Program for Hispanics|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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.
- Reduction in symptoms of major depression [ Time Frame: Measured at Months 12, 18, and 24 ]
- Quality of life [ Time Frame: Measured at Months 12, 18, and 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709150
|United States, California|
|University of Southern California School of Social Work|
|Los Angeles, California, United States, 90089-0411|
|Principal Investigator:||Kathleen R. Ell, DSW||University of Southern California|