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OpenTrials
Completed

NCT Number: NCT02185482

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NMP Medical Research Institute, Kaithal, Haryana, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physician Supported Care

Behavioral

Usual Care

Other

Primary outcomes

  1. change in depression using SCL-90 depression scale

    Time frame: Change from baseline to six month

Secondary outcomes

  1. Glycemic control measured using glycosylated hemoglobin levels

    Time frame: Change from baseline to six month

Other outcomes

  1. Global assessment of improvement using Patient Global Impression

    Time frame: Change from baseline to six months

Sponsors and collaborators

Lead sponsor

Adwin Life Care

Industry

Collaborators

  • NMP Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2014
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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