Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 5
- 主要终点
- YGTSS-TTS
研究概览
简要总结
Gilles da la Tourette syndrome (TS)* is a common chronic neuropsychiatric disorder characterized by motor and vocal tics. In most adult patients, quality of life is significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were recommended as first choice treatment for many years. Although efficacy could be demonstrated only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral Intervention for Tics (CBIT) (including psychoeducation, habit reversal training, function-based assessment and intervention, and relaxation training) is recommended as first line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of patients and will be - once developed and established - highly cost-effective (about € 100 vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized, controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8 sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects (after 3 and 6 months) will be evaluated.
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 (Investigator)
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
- •Chronic tic disorder or Tourette syndrome according to DSM-5
- •Age ≥18 years; Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) > 14 or > 10 (for patients only with motor or vocal tics)
- •Clinical Global Impression-Severity Score (CGI-S) > 4
- •Medication for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study
- •Fluent German in speaking and writing
- •Ability to give informed consent and signed informed consent
排除标准
- •History of schizophrenia or pervasive developmental disorder
- •Comorbid obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), depression, anxiety disorder when unstable and/or in need of an initial adjustment for a therapy
- •History of behavioral treatment for tics
- •Current illicit substance abuse or addiction (clinically diagnosed)
- •Secondary tic disorder or other significant neurological and psychiatric disease
- •No internet access or ability to use the internet
- •Participation in a study with medicinal products or devices is not allowed within 6 weeks before inclusion or concurrent to this study
研究组 & 干预措施
iCBIT
internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training
干预措施: (i)Comprehensive Behavioral Intervention for Tics (Behavioral)
Control intervention/reference test
internet-delivered psychoeducation and relaxation training.
干预措施: internet-delivered psychoeducation and relaxation training (Behavioral)
face-to-face CBIT-treatment
face-to-face CBIT-treatment
干预措施: (i)Comprehensive Behavioral Intervention for Tics (Behavioral)
结局指标
主要结局
YGTSS-TTS
时间窗: 1 week after end of treatment
次要结局
- Conners' Adult ADHD Rating Scale (CAARS)(1 week, 3 months and 6 months after end of treatment.)
- Adult Tic Questionnaire (ATQ) (self-report rating)(1 week, 3 months and 6 months after end of treatment.)
- Tourette Syndrome-Quality of Life Scale (GTS-QoL)(1 week, 3 months and 6 months after end of treatment.)
- Premonitory Urge for Tics Scale (PUTS)(1 week, 3 months and 6 months after end of treatment.)
- Clinical Global Impression-Improvement Score (CGI-I)(1 week, 3 months and 6 months after end of treatment.)
- Clinical Global Impression - Severity Score (CGI-S)(1 week, 3 months and 6 months after end of treatment.)
- Modified Rush Video-Based Tic Rating Scale (MRVS)(1 week, 3 months and 6 months after end of treatment.)
- Beck Depression Inventory (BDI)(1 week, 3 months and 6 months after end of treatment.)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(1 week, 3 months and 6 months after end of treatment.)
- YGTSS-TTS(1 week, 3 months and 6 months after end of treatment.)
- Beck Anxiety Inventory (BAI)(1 week, 3 months and 6 months after end of treatment.)
- Working Alliance Inventory-Short Revised (WAI-SR)(1 week, 3 months and 6 months after end of treatment.)
研究者
Kirsten Mueller-Vahl
Professor, MD
Hannover Medical School
