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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Psychiatric Clinic of the Ludwig-Maximilians-University
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30559
      • Psychotherapist practice
  • North Rhine-Westphalia
    • Aachen, North Rhine-Westphalia, Germany, 52074
      • RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • University of Dresden, Dep. of Child and Adolescent Psychiatry
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iCBIT; 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; Other Names: (i)CBIT
Placebo Comparator: Control intervention/reference test; internet-delivered psychoeducation and relaxation training.	Behavioral: internet-delivered psychoeducation and relaxation training
Active Comparator: face-to-face CBIT-treatment	Behavioral: (i)Comprehensive Behavioral Intervention for Tics; Other Names: (i)CBIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
YGTSS-TTS	1 week after end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
YGTSS-TTS	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.
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.
Beck Depression Inventory (BDI)	1 week, 3 months and 6 months after end of treatment.
Conners' Adult ADHD Rating Scale (CAARS)	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.
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.

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Kirsten Mueller-Vahl, Prof., MD, Medical school Hannover, Clinic for Psychosomatics and Psychotherapy

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2016
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Tourette syndrome; Chronic tic disorders
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: online-tics iCBIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No