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临床试验/NCT05770947
NCT05770947已完成不适用

Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)

Yale University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)

研究概览

简要总结

This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).

详细描述

This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. Bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). Bulimia nervosa happens across different ages and body sizes. This study is focusing on adolescents who have a larger body size. Adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. Treatment will occur over telehealth (e.g., zoom), and the whole study is online.

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 (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Have higher weight (>85th BMI percentile or >85th percentile in past year)
  • 2 binge/purge episodes per month for the prior 3 months
  • Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials;
  • Provide an approval form from a healthcare provider;
  • Provide a signed and dated written assent (or consent for youth age 18 or 19) prior to study participation;
  • Provide a signed and dated written consent from one parent prior to study participation;
  • Be available for participation in the study for 4 months.

排除标准

  • Medical or psychiatric conditions requiring hospitalization or intensive care
  • anorexia nervosa
  • developmental or cognitive disorders that would interfere with therapy
  • pregnancy or breastfeeding
  • concurrent treatments (medication or psychological) influencing appetite or weight
  • began hormone therapy in prior 3 months

结局指标

主要结局

Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)

时间窗: baseline and post-treatment (Month 4)

Remission from binge eating and purging behaviors will be assessed by EDE-Q. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder behaviors.

次要结局

  • Change in Binge eating frequency assessed by the EDE-Q(baseline and post-treatment (Month 4))
  • Change in Purging frequency assessed by the EDE-Q(baseline and post-treatment (Month 4))
  • Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.(baseline and post-treatment (Month 4))
  • Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)(baseline and post-treatment (Month 4))
  • Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)(baseline and post-treatment (Month 4))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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