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临床试验/NCT00231985
NCT00231985已完成2 期

Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder

Massachusetts General Hospital6 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
122
试验地点
6
主要终点
Tic severity

研究概览

简要总结

This study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.

详细描述

Tourette syndrome and chronic tic disorder are neurological disorders characterized by tics. Tics are involuntary, rapid motor movements or vocalizations that occur suddenly and repeatedly. In adults, the symptoms of Tourette syndrome or chronic tic disorder can be severe. These symptoms often cause difficulties in interpersonal relationships and high unemployment rates. Medication treatments are available for both Tourette syndrome and chronic tic disorder, but most are not completely effective and cause considerable negative side effects. Therefore, non-medication treatments are needed. This study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.

Participants in this open-label study will be randomly assigned to receive either supportive therapy or habit-reversal therapy. Over the course of 10 weeks, all participants will receive 8 treatment sessions of their assigned therapy. The supportive therapy will focus on educating participants on what tics are, how tics present themselves, the causes of tics, the common conditions that may occur along with tics, and environmental factors that may affect their tics (e.g. family, social, school, stress). Habit-reversal therapy will consist of awareness training, relaxation training, self-monitoring, and competing response training. Tic severity, tic-related impairment, depressive symptoms, anxiety symptoms, and obsessive-compulsive symptoms will be assessed at each study session, using diagnostic interviews and self-report scales.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Meets DSM-IV diagnostic criteria for Tourette syndrome or chronic tic disorder
  • The primary reason for seeking treatment is Tourette syndrome and/or chronic tic disorder
  • Either Tourette syndrome or chronic tic disorder is of more concern than any other simultaneous disease or disorder
  • Score greater than 3 on the Clinical Global Impressions Severity Scale
  • Score greater than 14 on the Yale Global Tic Severity Scale
  • Unmedicated or on stable medication treatment for tics, obsessive compulsive disorder, attention deficit hyperactivity disorder, and/or depressive disorder for at least 6 weeks, and not planning to change medication for the duration of study participation

排除标准

  • Total tic score greater than 33
  • Score less than 80 on the Wechsler Test of Adult Reading
  • DSM-IV diagnosis of alcohol or substance dependence within the 3 months prior to study enrollment
  • Currently taking psychotropic medications for any psychiatric disorder (except for tics, obsessive compulsive disorder, attention deficit hyperactivity disorder, and/or depressive disorder)
  • Any serious psychiatric disorder (e.g., bipolar disorder, psychosis) that requires immediate alternative treatment
  • Previously treated with four or more sessions of habit-reversal therapy for tics

结局指标

主要结局

Tic severity

时间窗: Measured at Week 10

次要结局

  • Tic-related impairment(Measured at Week 10)
  • Depressive symptoms(Measured at Week 10)
  • Anxiety symptoms(Measured at Week 10)
  • Obsessive-compulsive symptoms(Measured at Week 10)

研究者

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

Sabine Wilhelm

PhD

Massachusetts General Hospital

研究点 (6)

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