<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02185482</url>
  </required_header>
  <id_info>
    <org_study_id>Adwin112</org_study_id>
    <nct_id>NCT02185482</nct_id>
  </id_info>
  <brief_title>Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus</brief_title>
  <official_title>Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adwin Life Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Adwin Life Care</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a high prevalence of depression in patients with diabetes mellitus. Depression has&#xD;
      been shown to be associated with poor self-management (adherence to diet, exercise, checking&#xD;
      blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality&#xD;
      physician's care for depression improves both depression and diabetes outcomes in patients&#xD;
      with depression and diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in depression using SCL-90 depression scale</measure>
    <time_frame>Change from baseline to six month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control measured using glycosylated hemoglobin levels</measure>
    <time_frame>Change from baseline to six month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Global assessment of improvement using Patient Global Impression</measure>
    <time_frame>Change from baseline to six months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Depression</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Physician Supported Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physician Supported Care</intervention_name>
    <arm_group_label>Physician Supported Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients are ambulatory,&#xD;
&#xD;
          -  Had adequate hearing to complete a telephone interview,&#xD;
&#xD;
          -  Diabetic patients screened for depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently in care with a psychiatrist;&#xD;
&#xD;
          -  Diagnosis of bipolar disorder or schizophrenia;&#xD;
&#xD;
          -  Use of antipsychotic or mood stabilizer medication&#xD;
&#xD;
          -  Mental confusion on interview, suggesting significant dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ram Sharma, MD</last_name>
    <role>Study Director</role>
    <affiliation>NMP Medical Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naresh C Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaithal Civil Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMP Medical Research Institute</name>
      <address>
        <city>Kaithal</city>
        <state>Haryana</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GyanSanjeevani</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>February 4, 2016</last_update_submitted>
  <last_update_submitted_qc>February 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychological counselling</keyword>
  <keyword>Randomized single blind study</keyword>
  <keyword>Depression</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02185482
org study id: Adwin112
nct id: NCT02185482
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: change in depression using SCL-90 depression scale
time frame: Change from baseline to six month
measure: Glycemic control measured using glycosylated hemoglobin levels
time frame: Change from baseline to six month
measure: Global assessment of improvement using Patient Global Impression
time frame: Change from baseline to six months
arm group label: Physician Supported Care
arm group type: Experimental
description: The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
arm group label: Usual care
arm group type: Other
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: Physician Supported Care
arm group label: Physician Supported Care
intervention type: Other
intervention name: Usual care
arm group label: Usual care
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ram Sharma, MD
role: Study Director
affiliation: NMP Medical Research Institute
last name: Naresh C Kumar, MD
role: Principal Investigator
affiliation: Kaithal Civil Hospital
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Depression
mesh term: Depressive Disorder