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

NCT02605902 | Completed

• 1 other identifier: online-tics iCBIT
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 5

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

Keywords

Chronic tic disorders; Tourette syndrome

Outcome Measures

Primary Outcomes (1)

• YGTSS-TTS

  1 week after end of treatment

Secondary Outcomes (12)

• 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.

Study Arms (3)

iCBIT

ACTIVE COMPARATOR

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

Control intervention/reference test

PLACEBO COMPARATOR

internet-delivered psychoeducation and relaxation training.

Behavioral: internet-delivered psychoeducation and relaxation training

face-to-face CBIT-treatment

ACTIVE COMPARATOR

face-to-face CBIT-treatment

Behavioral: (i)Comprehensive Behavioral Intervention for Tics

Interventions

(i)Comprehensive Behavioral Intervention for Tics BEHAVIORAL

Also known as: (i)CBIT

face-to-face CBIT-treatment; iCBIT

internet-delivered psychoeducation and relaxation training BEHAVIORAL

Control intervention/reference test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (5)

Psychiatric Clinic of the Ludwig-Maximilians-University

Munich, Bavaria, 80336, Germany

Location

Psychotherapist practice

Hanover, Lower Saxony, 30559, Germany

Location

RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics

Aachen, North Rhine-Westphalia, 52074, Germany

Location

University of Dresden, Dep. of Child and Adolescent Psychiatry

Dresden, Saxony, 01307, Germany

Location

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

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Tics; Tourette Syndrome

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kirsten Mueller-Vahl, Prof., MD

  Medical school Hannover, Clinic for Psychosomatics and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: September 29, 2016
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: May 27, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)