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临床试验/NCT04241120
NCT04241120已完成不适用

Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training

HabitAware Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月16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
15
试验地点
2
主要终点
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.

研究概览

简要总结

Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 18 years of age or older
  • Speak fluent English
  • Current diagnosis of TTM
  • Score above the normative mean on the automatic pulling subscale of the MIST-A
  • Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)

排除标准

  • Currently receiving psychotherapy
  • Other psychiatric condition requiring more immediate care
  • Have previously used any behavior awareness devices (e.g. Keen)

结局指标

主要结局

Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.

时间窗: Four weeks

Measured via post-treatment surveys.

次要结局

  • Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.(Four weeks)
  • Number of Participants That Can Implement HRT Procedures With 80% Accuracy(Four weeks)
  • Number of Participants With 30% Improvement in Clinical Symptoms(Four weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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