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临床试验/NCT05610839
NCT05610839已完成不适用

A Randomized Controlled Trial of a Fully-automated Self-help AEBT Website for Adults With Trichotillomania

Utah State University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年11月8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
101
试验地点
2
主要终点
Massachusetts General Hospital- Hair Pulling Scale (MGH-HPS)

研究概览

简要总结

Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Trichotillomania causes significant social impairment including affecting close relationships, pursuing occupational changes or advancement, or interfering with schooling (Grant et al., 2017; Woods, Flessner, Franklin, Wetterneck, et al., 2006). The core of the treatment of trichotillomania has traditionally been Habit Reversal Training (HRT) (Twohig, Bluett, et al., 2014). Another form of treatment that is gaining empirical support is Acceptance and Commitment Therapy (ACT) which has been studied in four randomized controlled trials, one studying ACT as a standalone treatment (Lee, Homan, et al., 2018), and three examining ACT combined with HRT (Twohig et al., 2021; Lee, Haeger, et al., 2018; Woods, Wetterneck, et al., 2006) which demonstrated efficacy of the combined treatment in decreasing pulling symptom severity.

The prevalence of trichotillomania in the US is 1-2% of the population and yet treatment access is limited by many issues including processionals' lack of knowledge of the disorder and low treatment accessibility (Walther et al., 2010). ACT- enhanced behavior therapy has been implemented using telehealth to reach a larger population (42.2% decrease pre-to-post treatment), but telehealth still requires therapist time and incurs notable costs (Lee, Haeger, et al., 2018). The present study aims to address the gap in trichotillomania treatment accessibility by examining the role of check-ins on adherence and efficacy on afully automated, web-based ACT-enhanced HRT treatment for adults with trichotillomania across the United States. We predict that the condition with check-ins will increase adherence and efficacy of the treatment significantly more than the condition without check-ins. Additionally, we predict that hair pulling severity and psychological flexibility will be significantly improved by the condition with check-ins compared to the condition without check-ins.

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

入选标准

  • Currently meet DSM-5 criteria for trichotillomania
  • searching for trichotillomania-based treatment
  • are atleast 18 years old
  • fluent English speakers
  • living in the U.S.

排除标准

  • currently receiving alternative therapy
  • currently modifying or starting psychotropic medication
  • previously met DSM-5 criteria for trichotillomania but are not, at the time of intake session, engaging in hair pulling

结局指标

主要结局

Massachusetts General Hospital- Hair Pulling Scale (MGH-HPS)

时间窗: 36 weeks

The MGH-HPS assesses urges to pull, pulling behavior, and the distress caused by pulling through a seven-item self-report measure. Items are rated individually on a scale from 0-4 and then the total scale is summed from 0-28-point total score. Higher scores indicate greater hair pulling severity. Treatment response is indicated by a seven-point reduction in score (Houghton et al., 2015). The MGH-HPS demonstrates good internal consistency (Keuthen et al., 1995), test-retest reliability and convergent and divergent validity (O'Sullivan et al., 1995).

次要结局

未报告次要终点

研究者

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

Michael Twohig, Ph.D.

Professor

Utah State University

研究点 (2)

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