Tic-DisorderNCT02190383
Efficacy of a Habit Reversal Treatment on Tic-symptoms
A study testing Habit Reversal Training in people with Tic-Disorder, run by University of Cologne at 1 site in Germany.
Trial summary
The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme in children and adolescents aged 8 to 18 years with tic disorders. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tic-Disorder
- What is being tested?
- Habit Reversal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Aug 2017
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-18 years
- Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
- YGTSS total score F95.2>13, F95.1>9
- Tics are the main problems
- IQ>80
- If medication, then has been stable for at least one months in medicated patients
Show all 9Show fewer
- No change in medication treatment is planned
- Ability to participate in weekly outpatient treatment
- Acceptance of randomization
Who cannot join
- Diagnosis of Autism Spectrum Disorder or Psychosis
- Parallel continuous psychotherapy of tics or comorbid
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Cologne, 50931
Katrin Woitecki, Dr, (+49)221-478-97991, Tic-Ambulanz@uk-koeln.de
About this study
Official title: Within Subject Design on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents With Tics
The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.
Read the detailed description
The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki \& Döpfner, 2011, 2012).
- Conditions
- Tic-Disorder
- Being tested
- Habit Reversal Training
- Keywords
- Tic-Disorder, Tourette-Disorder, Habit Reversal Training
- 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.
Habit Reversal TrainingBehavioural
awareness training, competing response training
| Study group | Role | What they receive |
|---|---|---|
| Habit Reversal Training | Experimental | At first patients get informed about Tics in general. Then the individual Tics are specified and the tic-reaction is looked at further. The Tic-Symptoms are observed and the premonitory urge is specified. For all individual tics a specific reversal movement is developed. Relaxation methods are introduced. Receives: Behavioral: Habit Reversal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
Measured: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Secondary outcomes (8)
Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating
The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
Measured: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Change in Symptom Checklist for Tic-Symptoms, clinical rating
The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians
Measured: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3)
Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10.
Measured: T0, after 8 weeks (T1), 24weeks (T3)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
The ZWIK assess OCD criteria.
Measured: T0, after 8 weeks (T1), 24 weeks (T3)
Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
The CBCL, TRF and YSR assess a variation of different criteria.
Measured: T0, after 8weeks (T1), 24weeks (T3)
Change in Tic-Symptoms (YGTSS-TIC), overall score
The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients
Measured: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Change in Tic-Symptoms (observation)
Tic symptoms are observed through video tapes and are rated through clinicians.
Measured: Between T1 and T3 up to 16 weeks, during each session/week
Change in self-esteem (Harter-Scale-SBB)(self rating)
The Harter-Scale is used to assess self-esteem
Measured: T0, after 8 weeks (T1), 24weeks (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tic-DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Manfred Döpfner, Prof. Dr., Study director, Department of Childhood and Adolescent Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190383
- Sponsor's protocol ID
- THICS-Study 2
- Status last verified
- Mar 2017
- First submitted
- 14 Apr 2014
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Woitecki K, Dopfner M. [Changes in comorbid symptoms and subjective interference in a habit reversal therapy in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2012 May;40(3):181-90. doi: 10.1024/1422-4917/a000168. German.
PubMed 22532110Woitecki K, Dopfner M. [Effects of habit reversal training in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2011 Nov;39(6):387-97. doi: 10.1024/1422-4917/a000137. German.
PubMed 22031011Woitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within Subject Design on the Efficacy of Habit Reversal Treatment Programme in Children and Adolescents With Tics
- ClinicalTrials.gov ID
- NCT02190383
- Acronym / sponsor ID
- THICS-Study 2
- Conditions
- Tic-Disorder
- Keywords
- Tic-Disorder, Tourette-Disorder, Habit Reversal Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 15 Jul 2014 (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.
The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme in children and adolescents aged 8 to 18 years with tic disorders.
Detailed description
The main purpose of this study is to evaluate the efficacy of a habit reversal based treatment programme for children and adolescents with tic disorders. This habit reversal treatment programme was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in a pilot-study (Woitecki \& Döpfner, 2011, 2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Habit Reversal Training | Experimental | Behavioral: Habit Reversal TrainingAt first patients get informed about Tics in general. Then the individual Tics are specified and the tic-reaction is looked at further. The Tic-Symptoms are observed and the premonitory urge is specified. For all individual tics a specific reversal movement is developed. Relaxation methods are introduced. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 8-18 years
- Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)
- YGTSS total score F95.2>13, F95.1>9
- Tics are the main problems
- IQ>80
Key exclusion criteria (2 listed)
- Diagnosis of Autism Spectrum Disorder or Psychosis
- Parallel continuous psychotherapy of tics or comorbid
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 |
|---|---|---|
| Habit Reversal Trainingawareness training, competing response training | Behavioural | Habit Reversal Training |
Primary outcome
Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
8 secondary outcomes
Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating
Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Change in Symptom Checklist for Tic-Symptoms, clinical rating
Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3)
Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
Time frame: T0, after 8 weeks (T1), 24weeks (T3)
Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
Time frame: T0, after 8 weeks (T1), 24 weeks (T3)
Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
Time frame: T0, after 8weeks (T1), 24weeks (T3)
Change in Tic-Symptoms (YGTSS-TIC), overall score
Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)
Change in Tic-Symptoms (observation)
Time frame: Between T1 and T3 up to 16 weeks, during each session/week
Change in self-esteem (Harter-Scale-SBB)(self rating)
Time frame: T0, after 8 weeks (T1), 24weeks (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Background: PubMed 22532110Woitecki K, Dopfner M. [Changes in comorbid symptoms and subjective interference in a habit reversal therapy in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2012 May;40(3):181-90. doi: 10.1024/1422-4917/a000168. German.
- Background: PubMed 22031011Woitecki K, Dopfner M. [Effects of habit reversal training in children with chronic tic disorder - a pilot study]. Z Kinder Jugendpsychiatr Psychother. 2011 Nov;39(6):387-97. doi: 10.1024/1422-4917/a000137. German.
- BackgroundWoitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.
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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.
University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
Cologne, Germany
Manfred Döpfner, Prof. Dr. study director
Department of Childhood and Adolescent Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Reversal Training in people with Tic-Disorder, run by University of Cologne at 1 site 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating (time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190383, which also lists 3 linked publications.
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 15 Mar 2017.