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Status unknownNCT02190383Updated Mar 15, 2017

Efficacy of a Habit Reversal Treatment on Tic-symptoms

An interventional study of Habit Reversal Training in Tic-Disorder, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-15.

Sponsored by University of Cologne · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
8 Years to 18 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Tic-Disorder

Keywords

  • Tic-Disorder, Tourette-Disorder, Habit Reversal Training
03

In context

Tics

65 studies on the registry are indexed under Tics; 11 are open to participants now.

This study's planned enrollment of 50 is above the median of 34 across 51 interventional studies indexed under Tics.

Browse Tics studies →

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

Browse University of Cologne studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • No change in medication treatment is planned
  • Ability to participate in weekly outpatient treatment
  • Acceptance of randomization

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder or Psychosis
  • Parallel continuous psychotherapy of tics or comorbid
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Habit Reversal Training

    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.

    Behavioral: Habit Reversal Training

Interventions

  • BehavioralHabit Reversal Training

    awareness training, competing response training

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)

Secondary outcomes

  1. 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

    Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)

  2. 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

    Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24 weeks (T3)

  3. 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.

    Time frame: T0, after 8 weeks (T1), 24weeks (T3)

  4. Change of comorbid OCD Symptoms (ZWIK-E), parent-rating

    The ZWIK assess OCD criteria.

    Time frame: T0, after 8 weeks (T1), 24 weeks (T3)

  5. Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating

    The CBCL, TRF and YSR assess a variation of different criteria.

    Time frame: T0, after 8weeks (T1), 24weeks (T3)

  6. 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

    Time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2) and 24weeks (T3)

  7. Change in Tic-Symptoms (observation)

    Tic symptoms are observed through video tapes and are rated through clinicians.

    Time frame: Between T1 and T3 up to 16 weeks, during each session/week

  8. Change in self-esteem (Harter-Scale-SBB)(self rating)

    The Harter-Scale is used to assess self-esteem

    Time frame: T0, after 8 weeks (T1), 24weeks (T3)

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy
    Cologne, 50931, Germany
    Recruiting
08

References and documents

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 22532110 ↗
  • Woitecki 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 22031011 ↗
  • Woitecki, K. & Döpfner, M. (2014). Therapieprogramm für Kinder und Jugendliche mit Tic-Störungen (THICS). Göttingen: Hogrefe.
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Aug 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2014
First posted
Jul 15, 2014
Start
Nov 2013
Primary completionEst.
Aug 2017
CompletionEst.
Aug 2017
Last update
Mar 15, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02190383
Lead sponsor
University of Cologne
Responsible party
Manfred Doepfner (Leading psychologist at the Department of Childhood and Adolescence Psychiatry, University of Cologne) — Principal investigator
First posted
Jul 15, 2014
Start date
Nov 2013
Primary completion
Aug 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
Mar 15, 2017

Study contacts

Manfred Döpfner, Prof. Dr.
study director · Department of Childhood and Adolescent Psychiatry and Psychotherapy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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