Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
Primary Purpose
Depression, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Physician Supported Care
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Depression focused on measuring Psychological counselling, Randomized single blind study, Depression, Diabetes
Eligibility Criteria
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.
Sites / Locations
- NMP Medical Research Institute
- GyanSanjeevani
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Physician Supported Care
Usual care
Arm Description
The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
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.
Outcomes
Primary Outcome Measures
change in depression using SCL-90 depression scale
Secondary Outcome Measures
Glycemic control measured using glycosylated hemoglobin levels
Full Information
NCT ID
NCT02185482
First Posted
July 4, 2014
Last Updated
February 4, 2016
Sponsor
Adwin Life Care
Collaborators
NMP Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02185482
Brief Title
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
Official Title
Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adwin Life Care
Collaborators
NMP Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Type 2 Diabetes Mellitus
Keywords
Psychological counselling, Randomized single blind study, Depression, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physician Supported Care
Arm Type
Experimental
Arm Description
The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
Arm Title
Usual care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physician Supported Care
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
change in depression using SCL-90 depression scale
Time Frame
Change from baseline to six month
Secondary Outcome Measure Information:
Title
Glycemic control measured using glycosylated hemoglobin levels
Time Frame
Change from baseline to six month
Other Pre-specified Outcome Measures:
Title
Global assessment of improvement using Patient Global Impression
Time Frame
Change from baseline to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram Sharma, MD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Naresh C Kumar, MD
Organizational Affiliation
Kaithal Civil Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP Medical Research Institute
City
Kaithal
State/Province
Haryana
Country
India
Facility Name
GyanSanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
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Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
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