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临床试验/NCT04486742
NCT04486742已完成不适用

Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema

Northwestern University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月1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
20
试验地点
2
主要终点
Itch Severity Numerical Rating Scale

研究概览

简要总结

The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema.

详细描述

Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination) on their itch. Rumination is a maladaptive method of responding to distress, in which the individual thinks obsessively about the source of distress. The rumination on chronic itch in eczema can have detrimental effects on one's quality of life, as well as induce significant anxiety about when itch will return, how long it will last, and how it will affect physical and social functioning.

Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on teaching strategies so that the individual can examine distressing thoughts objectively and determine their validity, replace negative thinking patterns with more adaptive thought patterns, and increase the individual's awareness to their problematic thought patterns. Additionally, CBT helps the individual to implement behavioral strategies to cope with possibly anxiety-inducing situations, such as scratching while trying to go to sleep.

The investigators hypothesize that an Itch CBT intervention is an effective, non-medication-based, easy to implement strategy to improve itch in children with eczema.

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe atopic dermatitis [assessed by Patient Oriented Eczema Measure (POEM)score of >-8 OR NRS itch score of >= 4].
  • English speaking.
  • Currently receiving treatment at Lurie Children's Hospital for atopic dermatitis.
  • Parent or guardian available to participate in protocol.
  • Have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can be used to access Zoom conference technology for telemedicine visits.

排除标准

  • Inability to comprehend and complete questionnaires.
  • History of intellectual disability or psychosis.

结局指标

主要结局

Itch Severity Numerical Rating Scale

时间窗: Baseline to Week 4

Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome.

次要结局

  • PROMIS Anxiety and Depression(Baseline to Week 4)
  • PROMIS Pediatric Itch - Short Form 1 (2+6)(Baseline to Week 4)
  • Itch Rumination Questionnaire(Baseline to Week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Paller

Study Principal Investigator

Northwestern University

研究点 (2)

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