A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Type 2 Diabetes Clinical Trial

Official title:

A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939250
• Other study ID #: STU 042009-010
• Secondary ID: R34DK081031
• Status: Completed
• Phase: Phase 4
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetes Mellitus
• Major Depressive Disorder
• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes and depression intervention
Disease self management for diabetes and depression
• Diabetes intervention
Disease self management for diabetes

Locations

Country	Name	City	State
United States	Family and Community Medicine Clinic, University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin		week 16, 32
Secondary	Quick Inventory of Depressive Symptoms - Self Report		week 16, 32