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临床试验/NCT01395355
NCT01395355已完成不适用

An Integrative Intervention for Binge Eating Among Adolescent Girls

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up

研究概览

简要总结

This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. The investigators hypothesize that this intervention will serve to reduce binge and LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, and impulsivity, and improved quality of life.

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
Single (Participant)

入排标准

年龄范围
13 Years 至 22 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • currently meeting criteria for loss of control (LOC) eating or binge eating disorder (BED) as defined by Marcus and Kalarchian
  • age 13-22
  • lives with parent/primary caregiver most of the time

排除标准

  • alcohol or drug dependence in the last three months
  • current suicidal intent or clinically significant self-harm behaviors reported during the assessment
  • diagnosis of bulimia nervosa or anorexia nervosa in the last three months
  • presence of a developmental disability or neurological impairment that would impair the individual's ability to participate in the intervention
  • psychosis, including schizophrenia, or bipolar I disorder
  • not fluent in English (participant and parents/primary caregivers

结局指标

主要结局

Changes in frequency of episodes of loss of control and/or binge eating from baseline to three month follow-up

时间窗: 3-Month Follow-up

次要结局

  • Changes in the use of various cognitive emotion regulation strategies from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in eating disorder cognitions (e.g., eating, weight and shape concern, restrain) from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in health-related quality of life (including social, emotional, school, and physical functioning) from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in the frequency of eating as a means of coping with negative emotions, such as anger, sadness and anxiety, from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in anxiety symptoms from baseline to three month follow-up.(3-Month Follow-up)
  • Height and Weight(3-Month Follow-up)
  • Changes in depressive symptoms from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in impulsive behaviors from baseline to three month follow-up.(3-Month Follow-up)
  • Changes in the frequency of eating in the absence of hunger from baseline to three month follow-up.(3-Month Follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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