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

Not Applicable

Completed

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

• Registration Number: NCT01692574
• Lead Sponsor: University of Pennsylvania

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
GCBT-ND	Alternative Approach to Weight Loss	Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
DSE	Behavior Modification for Weight Loss	Behavior modification for weight loss combined with depression support and education.
Combined	Cognitive-Behavior Therapy for Depression	Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
GCBT-ND	Cognitive-Behavior Therapy for Depression	Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
Combined	Behavior Modification for Weight Loss	Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
DSE	Depression Support and Education	Behavior modification for weight loss combined with depression support and education.

Primary Outcome Measures

Name	Time	Method
Weight loss	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 Outcome Measures

Name	Time	Method
Changes in metabolic cardiovascular disease risk factors and inflammatory markers	Baseline to 20 weeks of treatment, follow up at week 46

Trial Locations

Locations (1)

University of Pennsylvania: Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States