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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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring depression and obesity treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
September 20, 2012
Last Updated
August 18, 2016
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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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