Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
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 or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches.
In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 years of age or older,
- •possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
- •be fluent in English
- •reside 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
- •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
Mindfulness-based Intervention for Tics
8-week group-based mindfulness-based program
干预措施: Mindfulness-based Intervention for Tics (Behavioral)
Tic Information and Coping Strategies
8-week group-based educational and supportive therapy program
干预措施: Tic Information and Coping Strategies (Behavioral)
结局指标
主要结局
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
时间窗: Screening, Week 0, Week 9, Week 13, Week 35
Clinician-rated measure of tic severity
次要结局
- Attention-Deficit Hyperactivity Rating Scale(Weeks 0, 9, 13, 35)
- Clinical Global Impressions Scale(Weeks 0, 9, 13, 35)
- Yale-Brown Obsessive Compulsive Scale(Weeks 0, 9, 13, 35)
- Depression Anxiety Stress Scale(Weeks 0, 9, 13, 35)
- Tic Rating Form(Weeks 1-8)
- Problem Rating Form(Weeks 1-8)
- Credibility and Expectancy Questionnaire(Week 3)
- Adult Tic Questionnaire(Weeks 0, 9, 13, 35)
- Premonitory Urge to Tic Scale(Weeks 0, 9, 13, 35)
- Patient Health Questionnaire-9(Weeks 0, 9, 13, 35)
- Patient Satisfaction Questionnaire(Week 9)
- Self Compassion Scale(Weeks 0, 9, 13, 35)
- Brief Irritability Test(Weeks 0, 9, 13, 35)
- Work and Social Adjustment Survey(Weeks 0, 9, 13, 35)
- Five Facet Mindfulness Questionnaire(Weeks 0, 4, 8, 9, 13, 35)
- Affective Reactivity Index(Weeks 0, 9, 13, 35)
研究者
Hannah Reese
Assistant Professor
Bowdoin College