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临床试验/NCT03525626
NCT03525626已完成不适用

Online Mindfulness-based Tic Reduction: Development and Testing (Phase One)

Bowdoin College2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Patient Satisfaction Questionnaire

研究概览

简要总结

Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments, find them unacceptable, or cannot access them. Thus, it is essential that researchers continue to pursue novel treatment approaches that can also be easily disseminated to those in need.

Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults with tic disorders. In the present study, the researchers aim to further develop this mindfulness-based intervention, adapt it to be delivered online and pilot test the intervention with a small group of participants. The data from this pilot test will inform a subsequent randomized controlled trial comparing online mindfulness-based tic reduction to online psychoeducation, relaxation, and supportive therapy.

The specific aim is to determine the feasibility and acceptability of Online Mindfulness-based Tic Reduction in 6 adults with TS or PTD.

The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and acceptable to adults with tic disorders as measured by participant satisfaction, qualitative participant feedback, home practice compliance, dropout, and adverse events.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •18 years of age or older,
  • •possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
  • •fluent in English
  • •residing in the United States,
  • •either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study

排除标准

  • •be receiving concurrent psychotherapy for the duration of the study
  • •have prior extensive experience with mindfulness and/or meditation and
  • •cannot have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).

研究组 & 干预措施

Online Mindfulness-based Tic Reduction

Experimental

干预措施: Online Mindfulness-based Tic Reduction (Behavioral)

结局指标

主要结局

Patient Satisfaction Questionnaire

时间窗: week 9

次要结局

  • Yale Global Tic Severity Scale (YGTSS)(Week 0, Week 9)
  • Homework Compliance Questionnaire(Weeks 1-8)
  • Adverse Events Monitoring Form(Weeks 1-9)
  • Attrition Form(Weeks 1-8)
  • Adult Tic Questionnaire(Weeks 0-9)
  • Clinical Global Impressions Scale-Severity(Week 0, Week 9)
  • Clinical Global Impressions Scale-Improvement(Week 9)

研究者

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

Hannah Reese

Assistant Professor

Bowdoin College

研究点 (2)

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