Clinical trial NCT01692574: Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)
Official title: Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Major Depressive Disorder
Dysthymic Disorder
Cardiovascular Disease
Keywords: depression and obesity treatment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-09-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: 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.


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

Primary outcomes:
measure: Weight loss
timeFrame: Baseline to 20 weeks of treatment, follow-up at week 46
Secondary outcomes:
measure: Changes in metabolic cardiovascular disease risk factors and inflammatory markers
timeFrame: Baseline to 20 weeks of treatment, follow up at week 46
Other outcomes:
measure: Changes in mood
timeFrame: Baseline to 20 weeks of treatment, follow up at week 46
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania: Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Center for Weight and Eating Disorders
name: Lucy F Hemsley-Faulconbridge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.