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

Not Applicable

Completed

• Conditions: Tics; Tourette Syndrome
• Interventions: Behavioral: (i)Comprehensive Behavioral Intervention for Tics; Behavioral: internet-delivered psychoeducation and relaxation training

• Registration Number: NCT02605902
• Lead Sponsor: Hannover Medical School

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Study Start: 2016-09-29
• Status Verified: 2019-10
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCBIT	(i)Comprehensive Behavioral Intervention for Tics	internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training
Control intervention/reference test	internet-delivered psychoeducation and relaxation training	internet-delivered psychoeducation and relaxation training.
face-to-face CBIT-treatment	(i)Comprehensive Behavioral Intervention for Tics	face-to-face CBIT-treatment

Primary Outcome Measures

Name	Time	Method
YGTSS-TTS	1 week after end of treatment

Secondary Outcome Measures

Name	Time	Method
Conners' Adult ADHD Rating Scale (CAARS)	1 week, 3 months and 6 months after end of treatment.
Adult Tic Questionnaire (ATQ) (self-report rating)	1 week, 3 months and 6 months after end of treatment.
Tourette Syndrome-Quality of Life Scale (GTS-QoL)	1 week, 3 months and 6 months after end of treatment.
Premonitory Urge for Tics Scale (PUTS)	1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression-Improvement Score (CGI-I)	1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression - Severity Score (CGI-S)	1 week, 3 months and 6 months after end of treatment.
Modified Rush Video-Based Tic Rating Scale (MRVS)	1 week, 3 months and 6 months after end of treatment.
Beck Depression Inventory (BDI)	1 week, 3 months and 6 months after end of treatment.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	1 week, 3 months and 6 months after end of treatment.
YGTSS-TTS	1 week, 3 months and 6 months after end of treatment.
Beck Anxiety Inventory (BAI)	1 week, 3 months and 6 months after end of treatment.
Working Alliance Inventory-Short Revised (WAI-SR)	1 week, 3 months and 6 months after end of treatment.

Trial Locations

Locations (5)

University of Dresden, Dep. of Child and Adolescent Psychiatry; 🇩🇪 Dresden, Saxony, Germany

RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics; 🇩🇪 Aachen, North Rhine-Westphalia, Germany

University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Psychotherapist practice; 🇩🇪 Hannover, Lower Saxony, Germany

Psychiatric Clinic of the Ludwig-Maximilians-University; 🇩🇪 Munich, Bavaria, Germany