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

NCT ID: NCT02185482

Last Updated: 2016-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Depression Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physician Supported Care

The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.

Group Type EXPERIMENTAL

Physician Supported Care

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Usual care

Intervention Type OTHER

Interventions

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Physician Supported Care

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NMP Medical Research Institute

OTHER

Sponsor Role collaborator

Adwin Life Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ram Sharma, MD

Role: STUDY_DIRECTOR

NMP Medical Research Institute

Naresh C Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Kaithal Civil Hospital

Locations

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NMP Medical Research Institute

Kaithal, Haryana, India

Site Status

GyanSanjeevani

Jaipur, Rajasthan, India

Site Status

Countries

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India

Other Identifiers

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Adwin112

Identifier Type: -

Identifier Source: org_study_id

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