Incorporating teleCBIT Into a Hospital-Based Tic Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
研究概览
简要总结
This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.
详细描述
Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
True masking not possible due to single-arm design. However, independent evaluator is blind to treatment utilization and progress.
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis)
- •Clinical Global Impressions - Severity Score > 3 (i.e., "moderately ill" or worse),
- •unmedicated or on stable medication treatment for tics and psychiatric problems,
- •fluency in English
- •a functional accessible home computer and high speed (i.e., cable/DSL) internet connection
- •willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns).
- •Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions.
排除标准
- •significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module);
- •prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care
- •lack of a functional home computer with high speed (i.e., cable or DSL) internet connection;
- •or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)
研究组 & 干预措施
teleCBIT
Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.
干预措施: teleCBIT (Behavioral)
结局指标
主要结局
Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
时间窗: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.
次要结局
- Clinical Global Impression: Improvement (CGI:I) Score(CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0))
- Adult Tic Questionnaire (ATQ) Total Tic Severity Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
- Yale Global Tic Severity Scale (YGTSS) Impairment Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
- Parent Tic Questionnaire (PTQ) Total Tic Severity Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
研究者
Matthew Capriotti
Assistant Professor
San Jose State University