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Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD) (TODI)

2016年8月18日 更新者:University of Pennsylvania

Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

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.

研究概览

研究类型

介入性

注册 (实际的)

76

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania: Center for Weight and Eating Disorders

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Combined
Group cognitive-behavior therapy for depression combined with behavior modification for weight loss
有源比较器:GCBT-ND
Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss
有源比较器:DSE
Behavior modification for weight loss combined with depression support and education.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Weight loss
大体时间: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.
Baseline to 20 weeks of treatment, follow-up at week 46

次要结果测量

结果测量
大体时间
Changes in metabolic cardiovascular disease risk factors and inflammatory markers
大体时间:Baseline to 20 weeks of treatment, follow up at week 46
Baseline to 20 weeks of treatment, follow up at week 46

其他结果措施

结果测量
大体时间
Changes in mood
大体时间:Baseline to 20 weeks of treatment, follow up at week 46
Baseline to 20 weeks of treatment, follow up at week 46

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lucy F Hemsley-Faulconbridge, PhD、University of Pennsylvania Center for Weight and Eating Disorders

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2012年9月20日

首先提交符合 QC 标准的

2012年9月20日

首次发布 (估计)

2012年9月25日

研究记录更新

最后更新发布 (估计)

2016年8月22日

上次提交的符合 QC 标准的更新

2016年8月18日

最后验证

2016年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Behavior Modification for Weight Loss的临床试验

3
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