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Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa

2016年7月18日 更新者:Boston University

Treatment of Bulimia Nervosa: Dysregulated Subtype

This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.

研究概览

详细说明

Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing and purging. People with the dysregulated subtype of BN experience behavioral impulsivity; disruption of cognitive, affective, behavioral, and neurophysiological processes (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no therapies have been tested for this specific population, and it is unknown whether therapy that directly focuses on treating BN symptoms or one that addresses both eating and personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which concentrates on modifying patients' behaviors and ways of thinking, has been effective in treating BN. This study will compare the effectiveness of two types of CBT, focused and broad, in treating adult women with the dysregulated subtype of BN.

Participants in this single-blind study will be randomly assigned to receive 20 sessions of either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before treatment begins, participants will complete a set of questionnaires pertaining to their experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires will be used throughout the study to assess participants' progress. Participants will also attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples and vital signs will also be taken at the time of the clinical interview and as needed later in the treatment process.

研究类型

介入性

注册 (实际的)

50

阶段

  • 阶段2

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

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Center for Anxiety and Related Disorders, Boston University

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 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Diagnosis of bulimia nervosa
  • Presence of borderline personality disorder features
  • History of one mood or anxiety episode within 2 years prior to study entry
  • If taking psychiatric medication, dose has been stable for at least 6 weeks at time of study entry

Exclusion Criteria:

  • Substance dependence
  • Diagnosis of bipolar I disorder
  • Psychosis
  • Mental retardation
  • Receiving psychosocial treatment

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:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:CBT-EF
Participants will receive cognitive behavioral therapy - focused
Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
实验性的:CBT-EB
Participants will receive cognitive behavioral therapy - broad
Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Eating disorder symptoms
大体时间:Measured throughout the study
Measured throughout the study

次要结果测量

结果测量
大体时间
Depression symptoms
大体时间:Measured throughout the study
Measured throughout the study
Anxiety symptoms
大体时间:Measured throughout the study
Measured throughout the study
Interpersonal relationships
大体时间:Measured throughout the study
Measured throughout the study

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:Heather Thompson-Brenner, PhD、Center for Anxiety and Related Disorders, Boston University

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

2007年7月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2007年6月28日

首先提交符合 QC 标准的

2007年6月28日

首次发布 (估计)

2007年7月2日

研究记录更新

最后更新发布 (估计)

2016年7月20日

上次提交的符合 QC 标准的更新

2016年7月18日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • K23MH071641 (美国 NIH 拨款/合同)
  • DATR AK-TNAI2 (National Institute of Mental Health)

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.

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