跳至主要内容
临床试验/NCT00272545
NCT00272545已完成不适用

Adaptation of a CBT Intervention for Eating Disorders

Drexel University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2006年1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
280
试验地点
1
主要终点
Body weight

研究概览

简要总结

This study will evaluate the effectiveness of a new approach to a normalization of eating program, based on principles of cognitive-behavioral therapy, in treating women with anorexia nervosa or bulimia nervosa.

详细描述

Eating disorders are real, treatable medical illnesses. They are often characterized by disturbances in eating behavior, such as drastic reduction of food intake or extreme overeating, as well as feelings of distress or extreme concern about body shape or weight. The two main types of eating disorders are anorexia nervosa and bulimia nervosa. A third type, binge-eating disorder, is pending approval as a formal psychiatric diagnosis. Eating disorders frequently develop during adolescence or early adulthood, and they occur more often in females than in males. Studies have shown cognitive behavioral therapy (CBT) to be the most effective approach to treating eating disorders. However, the applicability of these findings to clinical settings and intensive outpatient therapy programs (IOPs) remains unknown. This study will evaluate the effectiveness of a new approach to a normalization of eating (NOE) program, based on principles of CBT, in treating women with anorexia nervosa or bulimia nervosa.

Participants in this open-label study will be assigned to receive either treatment-as-usual (TAU) or NOE. Participants admitted to the study in the first 8 months of the trial will receive TAU. Those admitted after the first 8 months will take part in the NOE program. Participants may begin receiving treatment as soon as they enter the study and will continue receiving their assigned treatments for 6 weeks. All participants in the NOE group will be required to report to the study site three evenings a week. They will receive individual therapy, as well as take part in group and family therapy sessions. In addition, they will be supervised while eating a meal. Body weight, results of the Eating Disorders Examination and the Structured Clinical Interview for DSM-IV Axis I disorders, and self-report measures will be assessed post-treatment and at the Month 6 follow-up visit.

Note: Participants are recruited from the Renfrew Center's outpatient programs located in the Philadelphia area. Individuals outside of Renfrew cannot volunteer for this study. For more information about the Renfrew Center's inpatient or outpatient treatment programs, please call 1-800-RENFREW.

研究设计

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

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Diagnosis of an eating disorder or eating disorder not otherwise specified (except for binge eating disorder), as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association
  • •Agrees to remain in IOP treatment for at least 3 weeks
  • •Seeking treatment in one of the Renfrew Center's outpatient programs located in the Philadelphia area

排除标准

  • •Diagnosis of eating disorder not otherwise specified, including binge eating disorder
  • •Diagnosis of a psychotic disorder
  • •Transferred to inpatient treatment during the IOP stay because of worsening health

研究组 & 干预措施

1

Experimental

Participants will receive the normalization of eating program

干预措施: Normalization of Eating (NOE) (Behavioral)

2

Active Comparator

Participants will receive treatment as usual

干预措施: Treatment As Usual (TAU) (Behavioral)

结局指标

主要结局

Body weight

时间窗: Measured at baseline, discharge, and 6 month follow-up

Structured Clinical Interview

时间窗: Measured at baseline

Self-report

时间窗: Measured at baseline, discharge, and 6 month follow-up

Eating Disorders Examination

时间窗: Measured at baseline, discharge, and 6 month follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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