Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD) (TODI)
Primary Purpose
Obesity, Major Depressive Disorder, Dysthymic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Modification for Weight Loss
Alternative Approach to Weight Loss
Cognitive-Behavior Therapy for Depression
Depression Support and Education
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring depression and obesity treatment
Eligibility 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
Sites / Locations
- University of Pennsylvania: Center for Weight and Eating Disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Combined
GCBT-ND
DSE
Arm Description
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
Behavior modification for weight loss combined with depression support and education.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in metabolic cardiovascular disease risk factors and inflammatory markers
Full Information
NCT ID
NCT01692574
First Posted
September 20, 2012
Last Updated
August 18, 2016
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01692574
Brief Title
Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
Acronym
TODI
Official Title
Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Major Depressive Disorder, Dysthymic Disorder, Cardiovascular Disease
Keywords
depression and obesity treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined
Arm Type
Experimental
Arm Description
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
Arm Title
GCBT-ND
Arm Type
Active Comparator
Arm Description
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
Arm Title
DSE
Arm Type
Active Comparator
Arm Description
Behavior modification for weight loss combined with depression support and education.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Modification for Weight Loss
Intervention Type
Behavioral
Intervention Name(s)
Alternative Approach to Weight Loss
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavior Therapy for Depression
Intervention Type
Behavioral
Intervention Name(s)
Depression Support and Education
Primary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
Baseline to 20 weeks of treatment, follow-up at week 46
Secondary Outcome Measure Information:
Title
Changes in metabolic cardiovascular disease risk factors and inflammatory markers
Time Frame
Baseline to 20 weeks of treatment, follow up at week 46
Other Pre-specified Outcome Measures:
Title
Changes in mood
Time Frame
Baseline to 20 weeks of treatment, follow up at week 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy F Hemsley-Faulconbridge, PhD
Organizational Affiliation
University of Pennsylvania Center for Weight and Eating Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania: Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29932516
Citation
Faulconbridge LF, Driscoll CFB, Hopkins CM, Bailer Benforado B, Bishop-Gilyard C, Carvajal R, Berkowitz RI, DeRubeis R, Wadden TA. Combined Treatment for Obesity and Depression: A Pilot Study. Obesity (Silver Spring). 2018 Jul;26(7):1144-1152. doi: 10.1002/oby.22209.
Results Reference
derived
Learn more about this trial
Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
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