However, we do not intend to propose a program to replace consultation with a qualified medical doctor. An online treatment like ours cannot diagnose tics or test the indication for treatment; this always has to be done by a mental health specialist. Oftentimes, a patient might have several indications for treatment of which treatment for tics might be a minor one. This diagnostic work always has to be done by an expert.
That being said, our platform will be a very useful tool to supplement therapeutic work in the private practice. The platform could assist the patient with regular homework and exercises, while a therapist could focus on helping the patient troubleshoot as well as work on other issues that the patient might have.
This would be a timesaving combination for both the patient and the therapist. If shown to be effective, it will have the potential to bridge a large gap in the current health-care system in the treatment of tic disorders in Germany. Patients will be given oral and written explanation of the study including its potential risks, their right to withdraw consent at any time and the details of data protection and confidentiality and sufficient time to ask questions.
A signed consent form will be obtained.
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The patient information and a copy of the signed consent form will be handed to the patient. The data will be monitored by HCTC. All documents and information will be treated with strict confidentiality. Each study site will only be able to start data collection once the local Institutional Review Boards IRB approval is obtained.
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In the case of protocol changes an amendment will be submitted to the concerning IRB. The information collected in the study, especially the information related to the identity of the patient, will be confidential and protected by law. The collected data will be only accessible to the principal investigator and study staff of the respective study site as well as the monitors. The Minddistrict company will not have access to any personal data of the study participants.
The necessary login data will be provided and managed by the MHH research personal. Additionally, the Minddistrict portal will be SSL-encrypted. Video recordings from all participating study sites will be saved on an encrypted cloud offered by the University of Goettingen. After study completion, the results of the primary and secondary analyses will be published in international peer-reviewed journals. If shown to be effective the therapy platform will be made available to the general public in Germany in an appropriate manner.
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For this purpose, all necessary contractual arrangements between the MHH and the company Minddistrict will be clarified and defined before the beginning of the study. All authors approved of the final version of the manuscript. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Furthermore, the authors acknowledge Dr. Schroeder at the MHH for his consultation regarding safety aspects of the study and our biggest thanks go to the group leaders of all study sites and their teams: Irene Neuner, and Prof. At this point, the authors would like to commemorate our dearest colleague and beloved friend Prof. Andrea Ludolph who was going to join our study as the leader an additional study site Ulm , but passed away last year. National Center for Biotechnology Information , U. Journal List Front Psychiatry v. Published online Jun Author information Article notes Copyright and License information Disclaimer.
This article was submitted to Child and Adolescent Psychiatry, a section of the journal Frontiers in Psychiatry. Received Mar 31; Accepted Jun The use, distribution or reproduction in other forums is permitted, provided the original author s or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice.
No use, distribution or reproduction is permitted which does not comply with these terms. This article has been cited by other articles in PMC.
Abstract Background 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. Discussion 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. Ethics and dissemination All institutional review boards approve the protocol.
Tourette syndrome, tics, comprehensive behavioral intervention for tics, Internet-delivered comprehensive behavioral intervention for tics, habit reversal training, tele-health program. Introduction Gilles de la Tourette syndrome TS is a chronic neuropsychiatric disorder of childhood onset characterized by multiple motor and vocal tics.
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Table 1 Numbers of patients approximately recruited per center. Open in a separate window. Study Design This is a multicenter, prospective, randomized, controlled, observer-blind clinical trial on the efficacy of iCBIT in the treatment of tics in adult patients with TS or other chronic tic disorders. Eligibility Criteria The following inclusion criteria were defined: Exclusion criteria for this study are: Randomization Potential bias will be minimized by randomized treatment allocation.
Introduction
Blinding The study is observer blind. However, much effort is being put into avoiding the unblinding of study physicians: The examiners involved in the study will only carry out assessments. Apart from this, they will not be responsible for the treatment of patients during the study period and will not answer questions related to the therapy. Patients will be instructed in writing, neither to talk nor to ask questions about the contents of the therapy during the study visits. In addition, patients will be explicitly asked by the examiner at the beginning of each visit telephone and personal study visits , not to talk about the contents of their therapy.
Technical as well as content-related assistance related to the online platforms will be provided via a central hotline located in Hanover through a study staff member who will not be involved in assessments. If an investigator will be unblinded by a patient, this will be documented directly at the respective visit. Whenever possible, the patient will be reassessed by an alternative unblinded investigator at this visit if unblinding happened before the completion of this study visit and at all following visits. The therapist, who will treat patients with face-to-face CBIT within this study will not be involved in clinical assessments.
The recording and scoring of videos for tic assessment will not take place in the same center videos will be analyzed centrally at the MHH and only after termination of the study, thus blinding of the evaluating physician is guaranteed. Compliance In order to ensure that the patients will take active part in the Internet-based intervention, several automated checkups are integrated into the online platform for two purposes: Online Psychoeducation The control group will consist of psychoeducation only.
Booster Sessions In the period of time from the end of active treatment until the last follow-up visit see below , patients in all treatment arms will get the option of receiving booster sessions to refresh the therapy. Minddistrict The technical implementation of the Internet-based treatment is being set in place in cooperation with the Minddistrict company.
Table 2 Assessment schedule.
Study period Screening Baseline Treatment: Sample Size Calculation The sample size calculation is based on two studies in which the efficacy of face-to-face CBIT was compared with face-to-face psychoeducation in adult and pediatric patients with TS and chronic tic disorders 6 , 7. Primary Analysis The primary analysis will be performed in the intention-to-treat population. Safety For this study, no safety issues have been identified. Limitations All of the treatment arms in our study compare behavioral interventions, but there is no comparison to medical treatment.
Confidentiality The information collected in the study, especially the information related to the identity of the patient, will be confidential and protected by law.
Dissemination After study completion, the results of the primary and secondary analyses will be published in international peer-reviewed journals. Conflict of Interest Statement The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
The prevalence and epidemiology of Gilles de la Tourette syndrome: J Psychosom Res An international perspective on Tourette syndrome: Dev Med Child Neurol Limited knowledge of Tourette syndrome causes delay in diagnosis. J Neurol European clinical guidelines for Tourette syndrome and other tic disorders. Eur Child Adolesc Psychiatry Behavior therapy for children with Tourette disorder: Randomized trial of behavior therapy for adults with Tourette syndrome. Arch Gen Psychiatry Dutta N, Cavanna AE.
The effectiveness of habit reversal therapy in the treatment of Tourette syndrome and other chronic tic disorders: Funct Neurol Here are the most useful strategies and tactics you will need in order to influence the outcome of a Tic Tac Toe game and win. In this example, the player who has the Xs will make the first move. When you are the first to move, place your X in a corner square. If your opponent does not take the center square, you are most certainly assured to win! Place your second X in the center square to force your opponent to block you. Then place your third X in one of the border squares and next to the square where you made your first move.
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