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Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD) (TODI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692574
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 20, 2012
First Posted Date  ICMJE September 25, 2012
Last Update Posted Date August 22, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
Weight loss [ Time Frame: Baseline to 20 weeks of treatment, follow-up at week 46 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
Changes in metabolic cardiovascular disease risk factors and inflammatory markers [ Time Frame: Baseline to 20 weeks of treatment, follow up at week 46 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2012)
Changes in mood [ Time Frame: Baseline to 20 weeks of treatment, follow up at week 46 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
Official Title  ICMJE Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Major Depressive Disorder
  • Dysthymic Disorder
  • Cardiovascular Disease
Intervention  ICMJE
  • Behavioral: Behavior Modification for Weight Loss
  • Behavioral: Alternative Approach to Weight Loss
  • Behavioral: Cognitive-Behavior Therapy for Depression
  • Behavioral: Depression Support and Education
Study Arms  ICMJE
  • Experimental: Combined
    Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
    Interventions:
    • Behavioral: Behavior Modification for Weight Loss
    • Behavioral: Cognitive-Behavior Therapy for Depression
  • Active Comparator: GCBT-ND
    Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
    Interventions:
    • Behavioral: Alternative Approach to Weight Loss
    • Behavioral: Cognitive-Behavior Therapy for Depression
  • Active Comparator: DSE
    Behavior modification for weight loss combined with depression support and education.
    Interventions:
    • Behavioral: Behavior Modification for Weight Loss
    • Behavioral: Depression Support and Education
Publications * Faulconbridge LF, Driscoll CFB, Hopkins CM, Bailer Benforado B, Bishop-Gilyard C, Carvajal R, Berkowitz RI, DeRubeis R, Wadden TA. Combined Treatment for Obesity and Depression: A Pilot Study. Obesity (Silver Spring). 2018 Jul;26(7):1144-1152. doi: 10.1002/oby.22209.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2016)
76
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
90
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2
  • Age 18 - 70 years old
  • Presence of current major depressive disorder or dysthymic disorder
  • At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:

    • Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm)
    • Fasting blood glucose 100 mg/dL
    • Blood pressure 130/85 mm Hg
    • Triglycerides 150 mg/dL
    • Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)
    • OR medications for these conditions
  • Able to comply will all study procedures and schedule
  • Able to speak and read English

Exclusion Criteria

  • Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months
  • Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)
  • Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months
  • Weight loss of 5% or more in past 6 months
  • Enrollment in weight reduction program in prior 3 months
  • Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.)
  • Severe depression or severe impairment of functioning as judged by the assessor or PI
  • Presence of active suicidal ideation
  • Diabetes
  • Alcohol/drug abuse/dependence
  • Renal/hepatic disease
  • Change in thyroid medications in last 3 months
  • Pregnant/lactating, within 6-months post-partum
  • Current diagnoses, or history within the last 5 years, of anorexia or bulimia
  • Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months
  • Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition
  • History of bipolar disorder
  • History of head trauma
  • Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months)
  • Plans for bariatric surgery
  • Any other uncontrolled major medical problems
  • Women who are pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692574
Other Study ID Numbers  ICMJE 813829
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Lucy F Hemsley-Faulconbridge, PhD University of Pennsylvania Center for Weight and Eating Disorders
PRS Account University of Pennsylvania
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP