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

Tourette Syndrome Clinical Trial

— ONLINE-TICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605902
• Other study ID #: online-tics iCBIT
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

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.