An interventional study of (i)Comprehensive Behavioral Intervention for Tics and internet-delivered psychoeducation and relaxation training in Tics and Tourette Syndrome, sponsored by Hannover Medical School. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Hannover Medical School · Not applicable, Interventional, and Treatment
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.
65 studies on the registry are indexed under Tics; 11 are open to participants now.
This study's enrollment of 161 is above the median of 34 across 51 interventional studies indexed under Tics.
Browse Tics studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training
Behavioral: (i)Comprehensive Behavioral Intervention for Tics
internet-delivered psychoeducation and relaxation training.
Behavioral: internet-delivered psychoeducation and relaxation training
face-to-face CBIT-treatment
Behavioral: (i)Comprehensive Behavioral Intervention for Tics
Also known as: (i)CBIT
YGTSS-TTS
Time frame: 1 week after end of treatment
YGTSS-TTS
Time frame: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression-Improvement Score (CGI-I)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression - Severity Score (CGI-S)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Modified Rush Video-Based Tic Rating Scale (MRVS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Adult Tic Questionnaire (ATQ) (self-report rating)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Premonitory Urge for Tics Scale (PUTS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Beck Depression Inventory (BDI)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Beck Anxiety Inventory (BAI)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Working Alliance Inventory-Short Revised (WAI-SR)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Apr 2020, 42 months.
Of 22 interventional studies with no phase under Tics, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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