Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

描述（由申请人提供）：拟议研究的目标是进一步完善和评估一种不显眼的、增强意识和监测装置（AEMD），该装置将有助于治疗震颤躁狂症（TTM）。TTM与社会功能的显著损害有关，并且通常对自尊和幸福感产生深刻的负面影响。保守估计表明，美国人口的0.6%，或约180万人，符合TTM的完整诊断标准，约750万美国居民有严重的拔发问题。在接受治疗的患者中，60%至70%的患者对标准行为和药物治疗完全或部分无效，因此可能从该器械中受益。 TTM的最佳实践治疗涉及一种被称为习惯逆转疗法（HRT）的行为疗法。HRT要求TTM患者意识到自己的拔发行为，但大多数TTM患者在意识之外拔发。HRT还要求TTM患者记录他们拔头发行为的频率和持续时间，但一个人不可能监控他们不知道的行为。我们的第一阶段工作已经产生了解决这两个问题的原型设备（AEMD）。如果TTM患者的手接近他们的头发，原型AEMD会向他们发出信号，从而使他们意识到与拉扯有关的行为。原型AEMD还记录拔毛相关事件的时间、日期、持续时间和用户分类。我们发表的试点研究和随后的调查确定，原型AEMD成功地提醒TTM患者拉相关的行为，并在实验室环境中监测TTM相关的行为。在技术创新方面，该项目有可能开发出第一个可供使用的小型化、可穿戴、患者互动、实时数据收集和接近传感设备，该设备既能在患者出现精神疾病症状时提醒患者，又能跟踪问题的频率和严重程度。为AEMD开发的专利技术有可能对一系列其他健康/心理健康状况或工业应用产生巨大价值。 我们的总体第二阶段的目标是进一步完善AEMD，并评估其接受和实用性时，在一个开放的试验过程中使用的专业领导的习惯逆转疗法。假设AEMD将被TTM患者及其临床医生热情接受，并且在临床试验期间将按设计执行。第二阶段AEMD将包括佩戴在每个手腕上的手镯/手表，放置在脖子后基部的另一个元件，以及佩戴在腰带线或口袋中的寻呼机状警报装置。 如果发现AEMD是有用和有效的，它有可能显著减轻TTM的症状及其相关的功能障碍。AEMD也有很大的潜力，以改善评估和监测的TTM行为，这可能是非常宝贵的临床医生规划治疗和研究人员评估各种治疗策略的疗效。 公共卫生相关性：该第二阶段项目包括继续设计、开发和评估一种有助于治疗震颤性躁狂症的装置。该设备增强了对牵拉行为的意识，并监控这种禁用条件。

DESCRIPTION (provided by applicant): The goal of the proposed research is to further refine and evaluate an inconspicuous, awareness- enhancement and monitoring device (AEMD) which will assist the treatment of trichotillomania (TTM). TTM is associated with significant impairments in social functioning and often has a profound negative impact on self- esteem and well being. Conservative estimates suggest that 0.6% percent of the US population, or about 1.8 million people, meet full diagnostic criteria for TTM and approximately 7.5 million US residents have significant hair pulling problems. Of those treated, 60% to 70% are wholly or partially refractory to standard behavioral and pharmacological treatments and could therefore potentially benefit from this device. Best practice treatment for TTM involves a form of behavioral therapy known as habit reversal therapy (HRT). HRT requires persons with TTM to be aware of their hair pulling behaviors, yet the majority of persons with TTM pull most of their hair outside of their awareness. HRT also requires TTM sufferers to record the frequency and duration of their hair pulling behaviors yet it is impossible for a person to monitor behaviors that they are unaware of. Our Phase I efforts have produced a prototype device (AEMD) that solves these two problems. The prototype AEMD signals the TTM sufferer if their hand approaches their hair, thereby bringing pulling-related behavior into awareness. The prototype AEMD also logs the time, date, duration, and user classification of hair pulling related events. Our published pilot study and subsequent investigations establish that the prototype AEMD successfully alerts TTM sufferers to pulling-related behaviors and monitors TTM-related behavior in a laboratory setting. With respect to technological innovation, this project has the potential to develop the first available miniaturized, wearable, patient interactive, real-time data collecting and proximity-sensing device that both alerts sufferers to the presence of mental illness symptoms as they occur and keeps track of the frequency and intensity of the problem. The patented technologies developed for the AEMD have the potential to be of great value for a range of other health/mental health conditions or industrial applications. Our overall Phase II aim is to further refine the AEMD and to evaluate its acceptance and utility when used in an open trial course of professionally-led habit reversal therapy. It is hypothesized that the AEMD will be enthusiastically accepted by TTM sufferers and their clinicians and that it will perform as designed during the clinical trial. The Phase II AEMD will include a bracelet(s)/watch to be worn on each wrist, another element to be placed at the rear base of the neck, and a pager-like alert device to be worn at the belt-line or in a pocket. The AEMD, if found to be useful and effective, has the potential to significantly reduce the symptoms of TTM and its associated functional impairments. The AEMD also has great potential to improve assessment and monitoring of TTM behaviors which could be invaluable to clinicians planning treatment and to researchers evaluating the efficacy of various treatment strategies. PUBLIC HEALTH RELEVANCE: This Phase II project involves continued design, development and evaluation of a device that aids in the treatment of trichotillomania. The device enhanced awareness of pulling behavior and monitors this disabling condition.