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

May 26, 2020 updated by: Kirsten Mueller-Vahl, Hannover Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
YGTSS-TTS
Time Frame: 1 week after end of treatment
1 week after end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
YGTSS-TTS
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression-Improvement Score (CGI-I)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression - Severity Score (CGI-S)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Modified Rush Video-Based Tic Rating Scale (MRVS)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Adult Tic Questionnaire (ATQ) (self-report rating)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Premonitory Urge for Tics Scale (PUTS)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Beck Depression Inventory (BDI)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Conners' Adult ADHD Rating Scale (CAARS)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Beck Anxiety Inventory (BAI)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.
Working Alliance Inventory-Short Revised (WAI-SR)
Time Frame: 1 week, 3 months and 6 months after end of treatment.
1 week, 3 months and 6 months after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hannover Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirsten Mueller-Vahl, Prof., MD, Medical school Hannover, Clinic for Psychosomatics and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • online-tics iCBIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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