A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00939250
First received: July 13, 2009
Last updated: September 21, 2010
Last verified: September 2010

July 13, 2009
September 21, 2010
October 2009
December 2011   (final data collection date for primary outcome measure)
Glycosylated Hemoglobin [ Time Frame: week 16, 32 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00939250 on ClinicalTrials.gov Archive Site
Quick Inventory of Depressive Symptoms - Self Report [ Time Frame: week 16, 32 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Major Depressive Disorder
  • Behavioral: Diabetes and depression intervention
    Disease self management for diabetes and depression
    Other Names:
    • Measurement based care
    • Disease self management
  • Behavioral: Diabetes intervention
    Disease self management for diabetes
    Other Names:
    • Measurement based care
    • Disease self management
  • Experimental: Diabetes and depression intervention
    Measurement based care for diabetes and depression, disease self management for diabetes and depression
    Intervention: Behavioral: Diabetes and depression intervention
  • Active Comparator: Diabetes intervention
    Measurement based care for diabetes, disease self management for diabetes
    Intervention: Behavioral: Diabetes intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact: David W Morris, Ph.D. 214-648-0162 davidw.morris@utsouthwestern.edu
United States
 
NCT00939250
R34 DK81031
Yes
Madhukar H. Trivedi, M.D., The University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP