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

February 4, 2016 updated by: Adwin Life Care

Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Kaithal, Haryana, India
        • NMP Medical Research Institute
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Gyansanjeevani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physician Supported Care
The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
Behavioral: Physician Supported Care
Other: 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.
Other: Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in depression using SCL-90 depression scale
Time Frame: Change from baseline to six month
Change from baseline to six month

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycemic control measured using glycosylated hemoglobin levels
Time Frame: Change from baseline to six month
Change from baseline to six month

Other Outcome Measures

Outcome Measure
Time Frame
Global assessment of improvement using Patient Global Impression
Time Frame: Change from baseline to six months
Change from baseline to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adwin Life Care

Collaborators

NMP Medical Research Institute

Investigators

  • Study Director: Ram Sharma, MD, NMP Medical Research Institute
  • Principal Investigator: Naresh C Kumar, MD, Kaithal Civil Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adwin112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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