Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Reduction rate of Tic symptom severity before and after intervention
研究概览
简要总结
Study on the clinical efficacy and change of life quality through using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
详细描述
This study tried to explore the clinical effect of comprehensive behavioral intervention therapy (CBIT) on tic symptoms and the effect of improving the quality of life in children with tic disorders;explore the optimal treatment plan for tic disorder by comparing the clinical efficacy of CBIT therapy, drug therapy, and psychosocial education; explore the feasibility of using quality of life as an evaluation index for functional recovery after tic disorder treatment;
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for chronic tic disorder or Tourette syndrome (TS) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), and has been diagnosed by two pediatric psychiatrists who are associate chief physicians or more;
- •The age ranged from 9 to 16 years old;
- •The total score of tic symptoms in the Yale global Tic Severity Scale (YGTSS) is 13-30;
- •Childrens Webster's Intelligence Scale ≥ 85
- •Co-morbid ADHD, but the drug treatment dose for ADHD is stable (the drug has been stabilized for more than 6 weeks), or no drug has been taken at the beginning and during the stud
排除标准
- •There are brain organic diseases, metabolic diseases, psychiatric disorders, drug-induced involuntary movement and other extrapyramidal lesions;
- •Habit reversal training and other behavioral treatments for more than 4 weeks;
- •unwilling participants or disobedient subgroups in the study
研究组 & 干预措施
CBIT Group
Patients in this group would only receive the CBIT treatment.
干预措施: comprehensive behavioral intervention therapy (CBIT) (Behavioral)
Drug therapy Group
Patients in this group would only receive the drug therapy.
干预措施: Aripiprazole 5Mg Oral Tablet (Drug)
结局指标
主要结局
Reduction rate of Tic symptom severity before and after intervention
时间窗: Baseline, the tenth week of treatment
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening. Reduction rate = (YGTSS total score before intervention - YGTSS total score after intervention) / YGTSS total score before treatment × 100%
次要结局
- overall treatment response(The fifth week and the tenth week of treatment and three month after treatment end)
- life quality(The fifth week and the tenth week of treatment and three month after treatment end)