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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

YGTSS-TTS

Secondary Outcome

 YGTSS-TTS

Condition

Tics

Intervention

(i)Comprehensive Behavioral Intervention for Tics

Study Arms / Comparison Groups

 iCBIT
Description:  internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

161

Start Date

September 29, 2016

Completion Date

April 15, 2020

Primary Completion Date

April 15, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kirsten Mueller-Vahl, Prof., MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02605902

Organization ID

online-tics iCBIT


Responsible Party

Principal Investigator

Study Sponsor

Hannover Medical School


Study Sponsor

Kirsten Mueller-Vahl, Prof., MD, Principal Investigator, Medical school Hannover, Clinic for Psychosomatics and Psychotherapy


Verification Date

October 2019