A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

NCT ID: NCT00939250

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

Type 2 Diabetes; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diabetes and depression intervention

Measurement based care for diabetes and depression, disease self management for diabetes and depression

Group Type: EXPERIMENTAL

Diabetes and depression intervention

Intervention Type: BEHAVIORAL

Disease self management for diabetes and depression

Diabetes intervention

Measurement based care for diabetes, disease self management for diabetes

Group Type: ACTIVE_COMPARATOR

Diabetes intervention

Intervention Type: BEHAVIORAL

Disease self management for diabetes

Interventions

Diabetes and depression intervention

Disease self management for diabetes and depression

Intervention Type: BEHAVIORAL

Diabetes intervention

Disease self management for diabetes

Intervention Type: BEHAVIORAL

Other Intervention Names

Measurement based care; Disease self management; Measurement based care; Disease self management

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Madhukar H. Trivedi, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhukar H. Trivedi, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

David W. Morris, Ph.D.

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Locations

Family and Community Medicine Clinic, University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

R34DK081031

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 042009-010

Identifier Type: -

Identifier Source: org_study_id