Cardiovascular Disease, Dysthymic Disorder, Major Depressive Disorder, Obesity
Conditions
Keywords
depression and obesity treatment
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.
Interventions
BEHAVIORALBehavior Modification for Weight Loss
BEHAVIORALAlternative Approach to Weight Loss
BEHAVIORALCognitive-Behavior Therapy for Depression
BEHAVIORALDepression Support and Education
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in metabolic cardiovascular disease risk factors and inflammatory markers | Baseline to 20 weeks of treatment, follow up at week 46 |
Other
| Measure | Time frame |
|---|---|
| Changes in mood | Baseline to 20 weeks of treatment, follow up at week 46 |
Countries
United States
Outcome results
None listed