Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Combined
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
干预措施: Behavior Modification for Weight Loss (Behavioral)
Combined
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
干预措施: Cognitive-Behavior Therapy for Depression (Behavioral)
GCBT-ND
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
干预措施: Alternative Approach to Weight Loss (Behavioral)
GCBT-ND
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
干预措施: Cognitive-Behavior Therapy for Depression (Behavioral)
DSE
Behavior modification for weight loss combined with depression support and education.
干预措施: Behavior Modification for Weight Loss (Behavioral)
DSE
Behavior modification for weight loss combined with depression support and education.
干预措施: Depression Support and Education (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 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.
次要结局
- Changes in metabolic cardiovascular disease risk factors and inflammatory markers(Baseline to 20 weeks of treatment, follow up at week 46)