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NCT Number: NCT02605902

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.

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Key information

Conditions

Tics Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tic Disorders Tourette Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(i)Comprehensive Behavioral Intervention for Tics

Behavioral

Other names: (i)CBIT

internet-delivered psychoeducation and relaxation training

Behavioral

Primary outcomes

  1. YGTSS-TTS

    Time frame: 1 week after end of treatment

Secondary outcomes

  1. YGTSS-TTS

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  2. Clinical Global Impression-Improvement Score (CGI-I)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  3. Clinical Global Impression - Severity Score (CGI-S)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  4. Modified Rush Video-Based Tic Rating Scale (MRVS)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  5. Adult Tic Questionnaire (ATQ) (self-report rating)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  6. Tourette Syndrome-Quality of Life Scale (GTS-QoL)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  7. Premonitory Urge for Tics Scale (PUTS)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  8. Beck Depression Inventory (BDI)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  9. Conners' Adult ADHD Rating Scale (CAARS)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  10. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  11. Beck Anxiety Inventory (BAI)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

  12. Working Alliance Inventory-Short Revised (WAI-SR)

    Time frame: 1 week, 3 months and 6 months after end of treatment.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Acronym: ONLINE-TICS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2015
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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