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临床试验/NCT03673540
NCT03673540已完成不适用

Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization

Drexel University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年8月31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
61
试验地点
1
主要终点
Binge and purge frequency assessed by the Eating Disorder Examination

研究概览

简要总结

The study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes AND compensatory behaviors at least 1 time per week on average for the past 3 months)
  • •BMI >17.5
  • •Have a smartphone device
  • •Willing and able to use smartphone device to track food intake multiple times per day for 16 weeks

排除标准

  • •Pregnant or planning to become pregnant in the next year
  • •Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder)
  • •Have previously received a full trial of CBT for bulimia nervosa
  • •History of bariatric surgery

研究组 & 干预措施

CBT with smartphone application (EMI on)

Experimental

CBT with CBT+ smartphone application (EMI on)

干预措施: CBT+ application (Behavioral)

结局指标

主要结局

Binge and purge frequency assessed by the Eating Disorder Examination

时间窗: Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)

Frequency (number of days and number of instances) of binge eating and compensatory behaviors over the past 28 days assessed by the Eating Disorder Examination

次要结局

  • Eating Disorder Examination Questionnaire (EDE-Q)(Assessed at weekly treatment sessions throughout treatment duration (16 weeks))
  • Difficulties in Emotion Regulation Scale (DERS)(Assessed at weekly treatment sessions throughout treatment duration (16 weeks))
  • Technology Acceptance Model Scale (TAMS)(Assessed at weekly treatment sessions throughout treatment duration (16 weeks))
  • Feedback Questionnaire (FQ)(Assessed at weekly treatment sessions throughout treatment duration (16 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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