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

NCT ID: NCT02605902

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-29
• Study Completion Date: 2020-04-15

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.

Conditions

Tics; Tourette Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iCBIT

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

Group Type: ACTIVE_COMPARATOR

(i)Comprehensive Behavioral Intervention for Tics

Intervention Type: BEHAVIORAL

Control intervention/reference test

internet-delivered psychoeducation and relaxation training.

Group Type: PLACEBO_COMPARATOR

internet-delivered psychoeducation and relaxation training

Intervention Type: BEHAVIORAL

face-to-face CBIT-treatment

face-to-face CBIT-treatment

Group Type: ACTIVE_COMPARATOR

(i)Comprehensive Behavioral Intervention for Tics

Intervention Type: BEHAVIORAL

Interventions

(i)Comprehensive Behavioral Intervention for Tics

Intervention Type: BEHAVIORAL

internet-delivered psychoeducation and relaxation training

Intervention Type: BEHAVIORAL

Other Intervention Names

(i)CBIT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Mueller-Vahl

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Mueller-Vahl, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Medical school Hannover, Clinic for Psychosomatics and Psychotherapy

Locations

Psychiatric Clinic of the Ludwig-Maximilians-University

Munich, Bavaria, Germany

Psychotherapist practice

Hanover, Lower Saxony, 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

University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

online-tics iCBIT

Identifier Type: -

Identifier Source: org_study_id