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临床试验/NCT00494858
NCT00494858已完成不适用

Treatment of Bulimia Nervosa: Dysregulated Subtype

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Eating disorder symptoms

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

CBT-EF

Active Comparator

Participants will receive cognitive behavioral therapy - focused

干预措施: Cognitive behavioral therapy - focused (CBT-EF) (Behavioral)

CBT-EB

Experimental

Participants will receive cognitive behavioral therapy - broad

干预措施: Cognitive behavioral therapy - broad (EB) (Behavioral)

结局指标

主要结局

Eating disorder symptoms

时间窗: Measured throughout the study

次要结局

  • Anxiety symptoms(Measured throughout the study)
  • Interpersonal relationships(Measured throughout the study)
  • Depression symptoms(Measured throughout the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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