A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Conditions
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Type 2 Diabetes, Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Diabetes and depression intervention
* Behavioral: Diabetes intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-IV criteria for single or recurrent nonpsychotic MDD, and whom the physician deems it necessary to start on an antidepressant. Meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose > 126mg/dL on 2 separate occasions or an abnormal oral glucose tolerance test (OGTT) (2-hours post load glucose ≥ 200mg/dL). HbA1C > 7 Ability and willingness to provide written informed consent Hamilton Rating Scale for Depression (HRSD) score ≥ 14 Not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - MAOIs) Exclusion Criteria: Women who are pregnant or breastfeeding Type 1 diabetes General medical conditions that contraindicate use of antidepressant medications Unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina Current or past psychotic disorders including bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder; anorexia; bulimia High risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior Concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor History of current substance or alcohol dependence requiring detoxification within the last 6 months Currently suicidal or considered a high suicide risk Require inpatient treatment for their depression

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes and depression intervention<br>Measurement based care for diabetes and depression, disease self management for diabetes and depression | Behavioral: Diabetes and depression intervention<br>* Disease self management for diabetes and depression<br>* Other names: Disease self management;|
| Active Comparator: Diabetes intervention<br>Measurement based care for diabetes, disease self management for diabetes | Behavioral: Diabetes intervention<br>* Disease self management for diabetes<br>* Other names: Disease self management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Hemoglobin |  | week 16, 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptoms - Self Report |  | week 16, 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Depression, Disease Self Management, Measurement Based Care