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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01692574
First received: September 20, 2012
Last updated: March 20, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention
Obesity
Major Depressive Disorder
Dysthymic Disorder
Cardiovascular Disease
Behavioral: Behavior Modification for Weight Loss
Behavioral: Alternative Approach to Weight Loss
Behavioral: Cognitive-Behavior Therapy for Depression
Behavioral: Depression Support and Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Baseline to 20 weeks of treatment, follow-up at week 46 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in metabolic cardiovascular disease risk factors and inflammatory markers [ Time Frame: Baseline to 20 weeks of treatment, follow up at week 46 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Changes in mood [ Time Frame: Baseline to 20 weeks of treatment, follow up at week 46 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
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
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.
Behavioral: Behavior Modification for Weight Loss Behavioral: Depression Support and Education

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692574

Contacts
Contact: Lucy F Hemsley-Faulconbridge, PhD 215-746-7191 lucyhf@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania: Center for Weight and Eating Disorders Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colleen Bechtel, MS    215-573-5502    cbechtel@mail.med.upenn.edu   
Principal Investigator: Lucy F Hemsley-Faulconbridge, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Lucy F Hemsley-Faulconbridge, PhD University of Pennsylvania Center for Weight and Eating Disorders
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01692574     History of Changes
Other Study ID Numbers: 813829
Study First Received: September 20, 2012
Last Updated: March 20, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Pennsylvania:
depression and obesity treatment

Additional relevant MeSH terms:
Cardiovascular Diseases
Depressive Disorder
Depression
Dysthymic Disorder
Obesity
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014