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临床试验/NCT02605902
NCT02605902已完成不适用

Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders

Hannover Medical School5 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2016年9月29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
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

Active Comparator

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

Placebo Comparator

internet-delivered psychoeducation and relaxation training.

干预措施: internet-delivered psychoeducation and relaxation training (Behavioral)

face-to-face CBIT-treatment

Active Comparator

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

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

Kirsten Mueller-Vahl

Professor, MD

Hannover Medical School

研究点 (5)

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