Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02605902
Other study ID # online-tics iCBIT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 29, 2016
Est. completion date April 15, 2020

Study information

Verified date October 2019
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date April 15, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
(i)Comprehensive Behavioral Intervention for Tics

internet-delivered psychoeducation and relaxation training


Locations

Country Name City State
Germany RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics Aachen North Rhine-Westphalia
Germany University of Dresden, Dep. of Child and Adolescent Psychiatry Dresden Saxony
Germany Psychotherapist practice Hannover Lower Saxony
Germany University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology Lübeck Schleswig-Holstein
Germany Psychiatric Clinic of the Ludwig-Maximilians-University Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary YGTSS-TTS 1 week after end of treatment
Secondary YGTSS-TTS 1 week, 3 months and 6 months after end of treatment.
Secondary Clinical Global Impression-Improvement Score (CGI-I) 1 week, 3 months and 6 months after end of treatment.
Secondary Clinical Global Impression - Severity Score (CGI-S) 1 week, 3 months and 6 months after end of treatment.
Secondary Modified Rush Video-Based Tic Rating Scale (MRVS) 1 week, 3 months and 6 months after end of treatment.
Secondary Adult Tic Questionnaire (ATQ) (self-report rating) 1 week, 3 months and 6 months after end of treatment.
Secondary Tourette Syndrome-Quality of Life Scale (GTS-QoL) 1 week, 3 months and 6 months after end of treatment.
Secondary Premonitory Urge for Tics Scale (PUTS) 1 week, 3 months and 6 months after end of treatment.
Secondary Beck Depression Inventory (BDI) 1 week, 3 months and 6 months after end of treatment.
Secondary Conners' Adult ADHD Rating Scale (CAARS) 1 week, 3 months and 6 months after end of treatment.
Secondary Yale-Brown Obsessive Compulsive Scale (Y-BOCS) 1 week, 3 months and 6 months after end of treatment.
Secondary Beck Anxiety Inventory (BAI) 1 week, 3 months and 6 months after end of treatment.
Secondary Working Alliance Inventory-Short Revised (WAI-SR) 1 week, 3 months and 6 months after end of treatment.
See also
  Status Clinical Trial Phase
Recruiting NCT04851678 - Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Completed NCT04007913 - Incorporating teleCBIT Into a Hospital-Based Tic Program N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Completed NCT02256475 - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Phase 1
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT01329198 - Brain Stimulation for the Treatment of Tourette Syndrome N/A
Terminated NCT00952601 - Pilot Study of the Modified Atkins Diet for Tourette Syndrome Phase 1
Enrolling by invitation NCT00355927 - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. N/A
Completed NCT00206323 - A Randomized, Placebo-controlled, Tourette Syndrome Study. Phase 3
Completed NCT00004376 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Phase 3
Completed NCT04498364 - Extinction Learning in Adults With Tourette Syndrome N/A
Completed NCT00755339 - Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
Completed NCT03325010 - Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Completed NCT01702077 - Neurofeedback for Tourette Syndrome N/A
Completed NCT01719523 - Open-Trial of EPI-743 for Adults With Tourette Syndrome Phase 1
Completed NCT00231985 - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Phase 2
Completed NCT00206336 - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Phase 3
Terminated NCT03732534 - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome Phase 2
Completed NCT03625453 - Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Phase 2