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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01692574

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Changes in mood [Baseline to 20 weeks of treatment, follow up at week 46]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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