Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
NCT ID: NCT01692574
Last Updated: 2016-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
76 participants
INTERVENTIONAL
2012-08-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Depression Treatment and Risk for Cardiovascular Disease
NCT06170255
Biological CVD Risk Factors in Older Depressed Patients
NCT00318864
Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
NCT00091962
Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness
NCT02127671
Treatment of Depression After Coronary Bypass Surgery
NCT00042198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combined
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
Behavior Modification for Weight Loss
Cognitive-Behavior Therapy for Depression
GCBT-ND
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
Alternative Approach to Weight Loss
Cognitive-Behavior Therapy for Depression
DSE
Behavior modification for weight loss combined with depression support and education.
Behavior Modification for Weight Loss
Depression Support and Education
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Behavior Modification for Weight Loss
Alternative Approach to Weight Loss
Cognitive-Behavior Therapy for Depression
Depression Support and Education
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lucy F Hemsley-Faulconbridge, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Center for Weight and Eating Disorders
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania: Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
813829
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.