Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Depression; Type 2 Diabetes Mellitus
• Interventions: Behavioral: Physician Supported Care; Other: Usual care

• Registration Number: NCT02185482
• Lead Sponsor: Adwin Life Care

Brief Summary

There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-09
• Study Start: 2014-08
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Eligible patients are ambulatory,
• Had adequate hearing to complete a telephone interview,
• Diabetic patients screened for depression

Exclusion Criteria

• Currently in care with a psychiatrist;
• Diagnosis of bipolar disorder or schizophrenia;
• Use of antipsychotic or mood stabilizer medication
• Mental confusion on interview, suggesting significant dementia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician Supported Care	Physician Supported Care	The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
Usual care	Usual care	Usual care patients will be advised to consult with their primary care physician regarding depression. Primary care physicians prescribe antidepressant medication and can refer patients to the Mental Health Services.

Primary Outcome Measures

Name	Time	Method
change in depression using SCL-90 depression scale	Change from baseline to six month

Secondary Outcome Measures

Name	Time	Method
Glycemic control measured using glycosylated hemoglobin levels	Change from baseline to six month

Trial Locations

Locations (2)

NMP Medical Research Institute; 🇮🇳 Kaithal, Haryana, India

GyanSanjeevani; 🇮🇳 Jaipur, Rajasthan, India