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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK081031 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.
The overarching goal of the study is to translate research-based treatment procedures that have been shown to improve outcomes for both DM and MDD for use in primary care. More specifically, the aims are: 1) to evaluate the benefits of CDDI in improving diabetic outcomes compared to usual care for MDD plus disease self-management for diabetes; 2) to evaluate the benefits of CDDI in improving depression outcomes compared to the UC for MDD treatment protocol; and 3) to evaluate the benefits of CDDI in terms of improved (1) cardiovascular risk factors (blood pressure, body mass index, lipids, and abdominal fat), (2) levels of exercise and better diet, (3) clinician and patient satisfaction with care, (4) fidelity to treatment guidelines, and (5) cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes and depression intervention | Experimental | Measurement based care for diabetes and depression, disease self management for diabetes and depression |
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| Diabetes intervention | Active Comparator | Measurement based care for diabetes, disease self management for diabetes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes and depression intervention | Behavioral | Disease self management for diabetes and depression |
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| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin | week 16, 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptoms - Self Report | week 16, 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar H. Trivedi, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| David W. Morris, Ph.D. | University of Texas Southwestern Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family and Community Medicine Clinic, University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003865 | Depressive Disorder, Major |
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Diabetes intervention | Behavioral | Disease self management for diabetes |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |