Jakubovski Ewgeni, Reichert Cornelia, Karch Annika, Buddensiek Nadine, Breuer Daniel, Müller-Vahl Kirsten
Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School , Hannover , Germany.
Institute for Biostatistics, Hannover Medical School , Hannover , Germany.
Front Psychiatry. 2016 Jun 30;7:119. doi: 10.3389/fpsyt.2016.00119. eCollection 2016.
In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. 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. With this study, we want to demonstrate that iCBIT is superior to Internet-delivered psychoeducation and comparable to face-to-face CBIT.
This is a multicenter, prospective, randomized, controlled, observer-blind clinical trial, which will be conducted at five sites in Germany (ONLINE-TICS). Over the course of 2 years, 160 adult patients with chronic tic disorders will be assigned to one of three treatment arms: iCBIT (n = 72), online psychoeducation (n = 72), or face-to-face CBIT (n = 16). All treatments will consist of eighty therapy sessions over a period of 10 weeks and will follow the well-established CBIT manual by Woods and colleagues. The primary outcome measure will be the change in Yale Global Tic Severity Scale (YGTSS) at 1-week posttreatment. Secondary outcome measures include YGTSS change at 3 and 6 months, video- and self-ratings of tics as well as scales for psychiatric comorbidities assessed at each visit. The primary analysis will compare iCBIT to online psychoeducation using a mixed linear model with the YGTSS change as dependent variable. Secondary analyses will look at the comparison between iCBIT and face-to-face CBIT in a non-inferiority analysis.
If iCBIT proves to be effective, it would be a considerable contribution to close the wide gap in treatment providers for tic disorders not only in Germany but also in several other countries, since this Internet-delivered therapy does not require the supervision of a therapist. In addition, iCBIT would be a cost-effective and readily available treatment alternative that guarantees high quality standard of CBIT.
All institutional review boards approve the protocol. All participants will provide informed consent. There are no conflicts of interest. After study completion, the results will be published.
ClinicalTrials.gov Identifier: NCT02413216.
近年来，针对抽动秽语综合征患者的综合行为干预抽动症行为疗法（CBIT）已被公认为一种有效且安全的治疗方法。然而，在德国，由于训练有素的治疗师严重短缺，CBIT的推广受到限制。本研究的目的是通过创建一个全新且完善的互联网提供的CBIT（iCBIT）项目来克服这一缺陷。通过本研究，我们希望证明iCBIT优于互联网提供的心理教育，且与面对面的CBIT相当。
这是一项多中心、前瞻性、随机、对照、观察者盲法的临床试验，将在德国的五个地点进行（ONLINE-TICS）。在2年的时间里，160名患有慢性抽动障碍的成年患者将被分配到三个治疗组之一：iCBIT（n = 72）、在线心理教育（n = 72）或面对面CBIT（n = 16）。所有治疗将在10周的时间内包括80次治疗课程，并将遵循伍兹及其同事完善的CBIT手册。主要结局指标将是治疗后1周时耶鲁全球抽动严重程度量表（YGTSS）的变化。次要结局指标包括3个月和6个月时YGTSS的变化、抽动的视频和自我评分以及每次就诊时评估的精神共病量表。主要分析将使用以YGTSS变化为因变量的混合线性模型，将iCBIT与在线心理教育进行比较。次要分析将在非劣效性分析中观察iCBIT与面对面CBIT之间的比较。
如果iCBIT被证明是有效的，这将对缩小抽动障碍治疗提供者方面的巨大差距做出重大贡献，不仅在德国，而且在其他几个国家也是如此，因为这种互联网提供的疗法不需要治疗师的监督。此外，iCBIT将是一种具有成本效益且易于获得的治疗选择，可保证CBIT的高质量标准。
所有机构审查委员会均批准该方案。所有参与者将提供知情同意书。不存在利益冲突。研究完成后，结果将予以发表。
ClinicalTrials.gov标识符：NCT02413216。
