<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/NCT01692574</url>
  </required_header>
  <id_info>
    <org_study_id>813829</org_study_id>
    <nct_id>NCT01692574</nct_id>
  </id_info>
  <brief_title>Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)</brief_title>
  <acronym>TODI</acronym>
  <official_title>Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether individuals who suffer from depression and obesity are able to lose&#xD;
      weight and show improvements in mood and cardiovascular disease risk factors following 20&#xD;
      weeks of a combined treatment of cognitive-behavior therapy for depression and behavior&#xD;
      modification for weight loss. Participants will be assigned to one of three treatments: 1)&#xD;
      cognitive-behavior therapy for the treatment of depression combined with an alternative&#xD;
      approach to weight loss, 2) a weight loss intervention combined with a depression support and&#xD;
      education , or 3) cognitive-behavioral therapy for depression combined with a weight loss&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Baseline to 20 weeks of treatment, follow-up at week 46</time_frame>
    <description>To determine whether depressed, obese individuals who receive the combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss are able to lose 5% of their initial weight at the end of 20 weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolic cardiovascular disease risk factors and inflammatory markers</measure>
    <time_frame>Baseline to 20 weeks of treatment, follow up at week 46</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in mood</measure>
    <time_frame>Baseline to 20 weeks of treatment, follow up at week 46</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Obesity</condition>
  <condition>Major Depressive Disorder</condition>
  <condition>Dysthymic Disorder</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Combined</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group cognitive-behavior therapy for depression combined with behavior modification for weight loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GCBT-ND</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DSE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavior modification for weight loss combined with depression support and education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavior Modification for Weight Loss</intervention_name>
    <arm_group_label>Combined</arm_group_label>
    <arm_group_label>DSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alternative Approach to Weight Loss</intervention_name>
    <arm_group_label>GCBT-ND</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavior Therapy for Depression</intervention_name>
    <arm_group_label>Combined</arm_group_label>
    <arm_group_label>GCBT-ND</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Depression Support and Education</intervention_name>
    <arm_group_label>DSE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2&#xD;
&#xD;
          -  Age 18 - 70 years old&#xD;
&#xD;
          -  Presence of current major depressive disorder or dysthymic disorder&#xD;
&#xD;
          -  At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:&#xD;
&#xD;
               -  Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88&#xD;
                  cm)&#xD;
&#xD;
               -  Fasting blood glucose 100 mg/dL&#xD;
&#xD;
               -  Blood pressure 130/85 mm Hg&#xD;
&#xD;
               -  Triglycerides 150 mg/dL&#xD;
&#xD;
               -  Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)&#xD;
&#xD;
               -  OR medications for these conditions&#xD;
&#xD;
          -  Able to comply will all study procedures and schedule&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months&#xD;
&#xD;
          -  Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood&#xD;
             stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may&#xD;
             be acceptable, provided they have been on a stable dose of these medications 3&#xD;
             months.)&#xD;
&#xD;
          -  Use of weight-loss medications or any medications known to significantly affect weight&#xD;
             (e.g., oral steroids) in past 3 months&#xD;
&#xD;
          -  Weight loss of 5% or more in past 6 months&#xD;
&#xD;
          -  Enrollment in weight reduction program in prior 3 months&#xD;
&#xD;
          -  Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months&#xD;
             (Note: participants in couples or family counseling will be allowed.)&#xD;
&#xD;
          -  Severe depression or severe impairment of functioning as judged by the assessor or PI&#xD;
&#xD;
          -  Presence of active suicidal ideation&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Alcohol/drug abuse/dependence&#xD;
&#xD;
          -  Renal/hepatic disease&#xD;
&#xD;
          -  Change in thyroid medications in last 3 months&#xD;
&#xD;
          -  Pregnant/lactating, within 6-months post-partum&#xD;
&#xD;
          -  Current diagnoses, or history within the last 5 years, of anorexia or bulimia&#xD;
&#xD;
          -  Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months&#xD;
&#xD;
          -  Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general&#xD;
             medical condition&#xD;
&#xD;
          -  History of bipolar disorder&#xD;
&#xD;
          -  History of head trauma&#xD;
&#xD;
          -  Any changes in smoking behavior in prior 3 months (or plans to change in the next 3&#xD;
             months)&#xD;
&#xD;
          -  Plans for bariatric surgery&#xD;
&#xD;
          -  Any other uncontrolled major medical problems&#xD;
&#xD;
          -  Women who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucy F Hemsley-Faulconbridge, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania Center for Weight and Eating Disorders</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania: Center for Weight and Eating Disorders</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 18, 2016</last_update_submitted>
  <last_update_submitted_qc>August 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depression and obesity treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Dysthymic 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/NCT01692574
org study id: 813829
nct id: NCT01692574
lead sponsor: 
collaborator: 
has dmc: Yes
To determine whether individuals who suffer from depression and obesity are able to lose
      weight and show improvements in mood and cardiovascular disease risk factors following 20
      weeks of a combined treatment of cognitive-behavior therapy for depression and behavior
      modification for weight loss. Participants will be assigned to one of three treatments: 1)
      cognitive-behavior therapy for the treatment of depression combined with an alternative
      approach to weight loss, 2) a weight loss intervention combined with a depression support and
      education , or 3) cognitive-behavioral therapy for depression combined with a weight loss
      intervention.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss
time frame: Baseline to 20 weeks of treatment, follow-up at week 46
description: To determine whether depressed, obese individuals who receive the combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss are able to lose 5% of their initial weight at the end of 20 weeks of treatment.
measure: Changes in metabolic cardiovascular disease risk factors and inflammatory markers
time frame: Baseline to 20 weeks of treatment, follow up at week 46
measure: Changes in mood
time frame: Baseline to 20 weeks of treatment, follow up at week 46
arm group label: Combined
arm group type: Experimental
description: Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
arm group label: GCBT-ND
arm group type: Active Comparator
description: Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
arm group label: DSE
arm group type: Active Comparator
description: Behavior modification for weight loss combined with depression support and education.
intervention type: Behavioral
intervention name: Behavior Modification for Weight Loss
arm group label: Combined
arm group label: DSE
intervention type: Behavioral
intervention name: Alternative Approach to Weight Loss
arm group label: GCBT-ND
intervention type: Behavioral
intervention name: Cognitive-Behavior Therapy for Depression
arm group label: Combined
arm group label: GCBT-ND
intervention type: Behavioral
intervention name: Depression Support and Education
arm group label: DSE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lucy F Hemsley-Faulconbridge, PhD
role: Principal Investigator
affiliation: University of Pennsylvania Center for Weight and Eating Disorders
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Obesity
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Dysthymic Disorder