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OpenTrials
Completed

NCT Number: NCT01692574

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania: Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavior modification for weight loss

Behavioral

Alternative Approach to Weight Loss

Behavioral

Cognitive-Behavior Therapy for Depression

Behavioral

Depression Support and Education

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in metabolic cardiovascular disease risk factors and inflammatory markers

    Time frame: Baseline to 20 weeks of treatment, follow up at week 46

Other outcomes

  1. Changes in mood

    Time frame: Baseline to 20 weeks of treatment, follow up at week 46

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

Acronym: TODI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2012
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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