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

University of Pennsylvania

Status: Completed

Conditions: Major Depressive Disorder; Dysthymic Disorder; Obesity; Cardiovascular Disease

Treatments: Behavioral: Cognitive-Behavior Therapy for Depression; Behavioral: Depression Support and Education; Behavioral: Alternative Approach to Weight Loss; Behavioral: Behavior Modification for Weight Loss

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01692574

813829

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

Combined

Experimental group

Description:

Group cognitive-behavior therapy for depression combined with behavior modification for weight loss

Treatment:

Behavioral: Cognitive-Behavior Therapy for Depression

Behavioral: Behavior Modification for Weight Loss

GCBT-ND

Active Comparator group

Description:

Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss

Treatment:

Behavioral: Cognitive-Behavior Therapy for Depression

Behavioral: Alternative Approach to Weight Loss

DSE

Active Comparator group

Description:

Behavior modification for weight loss combined with depression support and education.

Treatment:

Behavioral: Depression Support and Education

Behavioral: Behavior Modification for Weight Loss