Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
TODI
Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2012
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedAugust 22, 2016
August 1, 2016
3.3 years
September 20, 2012
August 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in metabolic cardiovascular disease risk factors and inflammatory markers
Baseline to 20 weeks of treatment, follow up at week 46
Other Outcomes (1)
Changes in mood
Baseline to 20 weeks of treatment, follow up at week 46
Study Arms (3)
Combined
EXPERIMENTALGroup cognitive-behavior therapy for depression combined with behavior modification for weight loss
GCBT-ND
ACTIVE COMPARATORGroup cognitive-behavior therapy for depression combined with an alternative approach to weight loss
DSE
ACTIVE COMPARATORBehavior modification for weight loss combined with depression support and education.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania: Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 29932516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucy F Hemsley-Faulconbridge, PhD
University of Pennsylvania Center for Weight and Eating Disorders
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 25, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
August 22, 2016
Record last verified: 2016-08