TicsONLINE-TICSNCT02605902
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
A study testing (i)Comprehensive Behavioral Intervention for Tics and internet-delivered psychoeducation and relaxation training in people with Tics and Tourette Syndrome, run by Hannover Medical School at 5 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tics, Tourette Syndrome
- What is being tested?
- (i)Comprehensive Behavioral Intervention for Tics and internet-delivered psychoeducation and relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 5 sitesGermany
- Study dates
- 29 Sep 2016to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
Aachen, North Rhine-Westphalia, 52074
University of Dresden, Dep. of Child and Adolescent Psychiatry
Dresden, Saxony, 01307
Psychotherapist practice
Hanover, Lower Saxony, 30559
University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology
Lübeck, Schleswig-Holstein, 23538
Psychiatric Clinic of the Ludwig-Maximilians-University
Munich, Bavaria, 80336
About this study
Official title: 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.
- Conditions
- Tics, Tourette Syndrome
- Being tested
- (i)Comprehensive Behavioral Intervention for Tics, internet-delivered psychoeducation and relaxation training
- Keywords
- Chronic tic disorders, Tourette syndrome
- Medical subject headings
- Tics, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(i)Comprehensive Behavioral Intervention for TicsBehavioural
Also called (i)CBIT
internet-delivered psychoeducation and relaxation trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: (i)Comprehensive Behavioral Intervention for Tics |
| Control intervention/reference test | Placebo comparator | internet-delivered psychoeducation and relaxation training. Receives: Behavioral: internet-delivered psychoeducation and relaxation training |
| face-to-face CBIT-treatment | Active comparator | face-to-face CBIT-treatment Receives: Behavioral: (i)Comprehensive Behavioral Intervention for Tics |
What is being measured
The primary outcome is the main question the study is designed to answer.
YGTSS-TTS
Measured: 1 week after end of treatment
Secondary outcomes (12)
YGTSS-TTS
Measured: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression-Improvement Score (CGI-I)
Measured: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression - Severity Score (CGI-S)
Measured: 1 week, 3 months and 6 months after end of treatment.
Modified Rush Video-Based Tic Rating Scale (MRVS)
Measured: 1 week, 3 months and 6 months after end of treatment.
Adult Tic Questionnaire (ATQ) (self-report rating)
Measured: 1 week, 3 months and 6 months after end of treatment.
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Measured: 1 week, 3 months and 6 months after end of treatment.
Premonitory Urge for Tics Scale (PUTS)
Measured: 1 week, 3 months and 6 months after end of treatment.
Beck Depression Inventory (BDI)
Measured: 1 week, 3 months and 6 months after end of treatment.
Conners' Adult ADHD Rating Scale (CAARS)
Measured: 1 week, 3 months and 6 months after end of treatment.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 1 week, 3 months and 6 months after end of treatment.
Beck Anxiety Inventory (BAI)
Measured: 1 week, 3 months and 6 months after end of treatment.
Working Alliance Inventory-Short Revised (WAI-SR)
Measured: 1 week, 3 months and 6 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start29 Sep 2016
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Mueller-Vahl, Hannover Medical School
- Investigators
- Kirsten Mueller-Vahl, Prof., MD, Principal investigator, Medical school Hannover, Clinic for Psychosomatics and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605902
- Sponsor's protocol ID
- online-tics iCBIT
- Acronym
- ONLINE-TICS
- Status last verified
- Oct 2019
- First submitted
- 12 Nov 2015
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
- ClinicalTrials.gov ID
- NCT02605902
- Acronym / sponsor ID
- ONLINE-TICS / online-tics iCBIT
- Conditions
- Tics, Tourette Syndrome
- Keywords
- Chronic tic disorders, Tourette syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iCBIT | Active comparator | Behavioral: (i)Comprehensive Behavioral Intervention for Ticsinternet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training |
| Control intervention/reference test | Placebo comparator | Behavioral: internet-delivered psychoeducation and relaxation traininginternet-delivered psychoeducation and relaxation training. |
| face-to-face CBIT-treatment | Active comparator | Behavioral: (i)Comprehensive Behavioral Intervention for Ticsface-to-face CBIT-treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (i)Comprehensive Behavioral Intervention for TicsAlso: (i)CBIT | Behavioural | face-to-face CBIT-treatment, iCBIT |
| internet-delivered psychoeducation and relaxation training | Behavioural | Control intervention/reference test |
Primary outcome
YGTSS-TTS
Time frame: 1 week after end of treatment
12 secondary outcomes
YGTSS-TTS
Time frame: 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.
Clinical Global Impression - Severity Score (CGI-S)
Time frame: 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.
Adult Tic Questionnaire (ATQ) (self-report rating)
Time frame: 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.
Premonitory Urge for Tics Scale (PUTS)
Time frame: 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.
Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 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.
Beck Anxiety Inventory (BAI)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Mueller-Vahl, Prof., MD principal investigator
Medical school Hannover, Clinic for Psychosomatics and Psychotherapy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (i)Comprehensive Behavioral Intervention for Tics and internet-delivered psychoeducation and relaxation training in people with Tics and Tourette Syndrome, run by Hannover Medical School at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YGTSS-TTS (time frame: 1 week after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.