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A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT00939250
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Major Depressive Disorder Behavioral: Diabetes and depression intervention Behavioral: Diabetes intervention Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Study Start Date : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diabetes and depression intervention
Measurement based care for diabetes and depression, disease self management for diabetes and depression
Behavioral: Diabetes and depression intervention
Disease self management for diabetes and depression
Other Names:
  • Measurement based care
  • Disease self management

Active Comparator: Diabetes intervention
Measurement based care for diabetes, disease self management for diabetes
Behavioral: Diabetes intervention
Disease self management for diabetes
Other Names:
  • Measurement based care
  • Disease self management




Primary Outcome Measures :
  1. Glycosylated Hemoglobin [ Time Frame: week 16, 32 ]

Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms - Self Report [ Time Frame: week 16, 32 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT00939250


Locations
United States, Texas
Family and Community Medicine Clinic, University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Madhukar H. Trivedi, M.D. University of Texas Southwestern Medical Center
Study Director: David W. Morris, Ph.D. University of Texas Southwestern Medical Center

Responsible Party: Madhukar H. Trivedi, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00939250     History of Changes
Other Study ID Numbers: R34DK081031 ( U.S. NIH Grant/Contract )
R34DK081031 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Madhukar H. Trivedi, University of Texas Southwestern Medical Center:
Diabetes
Depression
Disease Self Management
Measurement Based Care

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Depressive Disorder
Depressive Disorder, Major
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders