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临床试验/NCT02747771
NCT02747771招募中不适用

The Norwegian Trichotillomania Project

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)

研究概览

简要总结

This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy for trichotillomania at three clinical sites in Norway.

详细描述

The Norwegian Trichotillomania Project is a multicenter study that aims at evaluating the effectiveness of behavioral group therapy for TTM, i.e., ACT (Acceptance and commitment therapy) enhanced habit reversal training (ACT-enhanced HRT).

Participants are adults or adolescents (16 year or older) who fulfill criteria for TTM according to DSM-IV. Inclusion started in January 2013 and will be completed by Mai 2016. Treatment is delivered at three treatment sites in Norway; in Kristiansand, Oslo, and Trondheim. Treatment is manualized, following the manual of Twohig and Woods, and consists of ten group sessions of three hours delivered at consecutive weeks, and two or three booster sessions during the first year after treatment.

Treatment outcome is evaluated by three outcome measures; the Massachusetts General Hospital - Hairpulling Scale (self-report); the National Institute of Mental Health Trichotillomania Severity Scale (clinical interview, conducted by independent evaluators); and the Clinical Global Impression Scale for TTM. Outcome is measured at three points in time; at baseline, at the end of treatment, and at one-year follow-up. Mixed models procedures in SPSS is used to analyze longitudinal data.

The first paper will be written on patients admitted to treatment from January 2013 to September 2014, and includes 53 patients (49 women and four men). By January 2016, fifty-one patients (96%) had participated in the one-year follow-up evaluation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 67 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Trichotillomania
  • Age between 16 and 67

排除标准

  • schizophrenia spectrum disorder
  • substance addiction
  • severe antisocial, schizotypal, or paranoid personality disorder
  • severe eating disorder,
  • ongoing suicidal ideation
  • pervasive developmental disorder
  • mental retardation and severe sequelae after brain injury.

结局指标

主要结局

Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)

时间窗: baseline, 12 weeks, 12 months

self-report

Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)

时间窗: baseline, 12 weeks, 12 months

clinical interview

次要结局

  • Change General Anxiety Disorder Scale (GAD-7)(baseline, 12 weeks, 12 months)
  • Change Metacognition Questionnaire (MCQ-30)(baseline, 12 weeks, 12 months)
  • Change Patient Health Questionnaire-9 (PHQ-9)(baseline, 12 weeks, 12 months)
  • Change in Acceptance and Action Questionnaire for Trichotillomania(baseline, 12 weeks, 12 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Hummelen

MD, PhD

Oslo University Hospital

研究点 (1)

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