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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185482
• Other study ID #: Adwin112
• Status: Completed
• Phase: N/A
• First received: July 4, 2014
• Last updated: February 4, 2016
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Adwin Life Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Physician Supported Care

Other:
• Usual care

Locations

Country	Name	City	State
India	GyanSanjeevani	Jaipur	Rajasthan
India	NMP Medical Research Institute	Kaithal	Haryana

Sponsors (2)

Lead Sponsor	Collaborator
Adwin Life Care	NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global assessment of improvement using Patient Global Impression		Change from baseline to six months	No
Primary	change in depression using SCL-90 depression scale		Change from baseline to six month	No
Secondary	Glycemic control measured using glycosylated hemoglobin levels		Change from baseline to six month	No