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

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

Conditions
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Obesity, Major Depressive Disorder, Dysthymic Disorder, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Behavior Modification for Weight Loss
* Behavioral: Alternative Approach to Weight Loss
* Behavioral: Cognitive-Behavior Therapy for Depression
* Behavioral: Depression Support and Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined<br>Group cognitive-behavior therapy for depression combined with behavior modification for weight loss | Behavioral: Behavior Modification for Weight Loss<br> <br> Behavioral: Cognitive-Behavior Therapy for Depression<br> <br> |
| Active Comparator: GCBT-ND<br>Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss | Behavioral: Alternative Approach to Weight Loss<br> <br> Behavioral: Cognitive-Behavior Therapy for Depression<br> <br> |
| Active Comparator: DSE<br>Behavior modification for weight loss combined with depression support and education. | Behavioral: Behavior Modification for Weight Loss<br> <br> Behavioral: Depression Support and Education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 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. | Baseline to 20 weeks of treatment, follow-up at week 46 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic cardiovascular disease risk factors and inflammatory markers |  | Baseline to 20 weeks of treatment, follow up at week 46 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression and obesity treatment