Back to resultsA Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Primary Purpose
Type 2 Diabetes, Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diabetes and depression intervention
Diabetes intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Depression, Disease Self Management, Measurement Based Care
Eligibility Criteria
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
Sites / Locations
- Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diabetes and depression intervention
Diabetes intervention
Arm Description
Measurement based care for diabetes and depression, disease self management for diabetes and depression
Measurement based care for diabetes, disease self management for diabetes
Outcomes
Primary Outcome Measures
Glycosylated Hemoglobin
Secondary Outcome Measures
Quick Inventory of Depressive Symptoms - Self Report
Full Information
NCT ID
NCT00939250
First Posted
July 13, 2009
Last Updated
September 1, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00939250
Brief Title
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Official Title
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Major Depressive Disorder
Keywords
Diabetes, Depression, Disease Self Management, Measurement Based Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes and depression intervention
Arm Type
Experimental
Arm Description
Measurement based care for diabetes and depression, disease self management for diabetes and depression
Arm Title
Diabetes intervention
Arm Type
Active Comparator
Arm Description
Measurement based care for diabetes, disease self management for diabetes
Intervention Type
Behavioral
Intervention Name(s)
Diabetes and depression intervention
Other Intervention Name(s)
Measurement based care, Disease self management
Intervention Description
Disease self management for diabetes and depression
Intervention Type
Behavioral
Intervention Name(s)
Diabetes intervention
Other Intervention Name(s)
Measurement based care, Disease self management
Intervention Description
Disease self management for diabetes
Primary Outcome Measure Information:
Title
Glycosylated Hemoglobin
Time Frame
week 16, 32
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms - Self Report
Time Frame
week 16, 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar H. Trivedi, M.D.
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David W. Morris, Ph.D.
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
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