Tourette's DisorderNCT02864589
Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder
A study testing Internet-delivered habit reversal training and Internet-delivered exposure and response prevention in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder
- What is being tested?
- Internet-delivered habit reversal training and Internet-delivered exposure and response prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2016to Jan 2018
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fulfill DSM-5 diagnostic criteria for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
- >15 (TD) or >10 (PTD) on Yale Global Tic Severity Scale (Impairment not included).
- Both child and parent are able to read and communicate in Swedish.
- Regular access to a computer and the Internet.
- Parent availability to support their child throughout the treatment.
Who cannot join
- Acute psychiatric problems such as severe depression, suicidal risk, substance abuse or another psychiatric disorder that could interfere with treatment.
- Lifetime history of global learning disability, pervasive developmental disorder, psychosis, bipolar disorder or organic brain disorder.
- Severe tics causing immediate risk to the patients or others and requiring urgent medical attention.
- Previous behavioural therapy (HRT or ERP), minimum 8 sessions with qualified therapist, within the last 12 months prior to assessment.
- Simultaneous psychological treatment for tic disorder.
- Initiation or adjustment of any psychotropic medication for tics within the last 6 weeks prior to assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study
The purpose of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
Read the detailed description
The primary objective of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD). The two modalities of IBT are habit reversal training (HRT) and exposure and response prevention (ERP). Secondary objectives are to evaluate whether IBT can decrease tic frequency and tic-related impairment, and, as both HRT and ERP have been proven efficacious in treating TD/PTD face-to-face, are any of the two treatments better suited to be delivered via the internet?
The design of the study is a randomized-controlled trial with 20 participants. Participants will be stratified by ADHD/ADD status.
The treatment duration is 10 weeks.
Feasibility and acceptability will be assumed if:
- The two treatments can be successfully adapted to a therapist guided internet-delivered format (technical feasibility)
- Patients/parents are willing to try the offered treatment modalities
- Participants complete the active parts of the treatment
- Referrers are open to the idea of internet-delivered treatment for TD or PTD
- We can recruit sufficient numbers of patients for a fully powered efficacy trial
Regarding the secondary objective, the primary outcome is tic severity measured by the Yale Global Tic Severity Scale (YGTSS). Participants will be assessed directly after treatment (post), and at 3, 6 and 12 months after treatment. Assessments at post-treatment and 3 month follow up will be performed by assessors blinded to the treatment condition. After 3 months, we will naturalistically follow up patients up to 12 months after the end of treatment. Data collection will finish 12 months after treatment.
- Being tested
- Internet-delivered habit reversal training, Internet-delivered exposure and response prevention
- Keywords
- Tourette, Tic, Tics
- Medical subject headings
- Tourette Syndrome, Bronchiolitis Obliterans Syndrome, Tic Disorders, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered habit reversal trainingBehavioural
Also called HRT, HR
The I-HRT group will receive a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on habit reversal training (i.e. Woods, D.W. (2008). Managing Tourette syndrome: A behavioral intervention for children and adults therapist guide. OUP, USA.) with added interactive features as videos and illustrations. In short, the participants practice to become more aware of their tics and inhibit them by performing competing responses (movements). The treatment is therapist guided: the participants have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
Internet-delivered exposure and response preventionBehavioural
Also called ERP
The I-ERP group receives a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on exposure and response prevention (i.e. Verdellen, C. et al. (2011). Tics: Therapist manual \& workbook for children. Boom, Amsterd.) with added interactive features as videos and illustrations. In short, the participants practice to suppress their tics for longer and longer times, at the same time as premonitory urges are intentionally provoked. The treatment is therapist-guided: the children and parents have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
| Study group | Role | What they receive |
|---|---|---|
| I-HRT | Experimental | Internet-delivered habit reversal training Receives: Behavioral: Internet-delivered habit reversal training |
| I-ERP | Experimental | Internet-delivered exposure and response prevention Receives: Behavioral: Internet-delivered exposure and response prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS)
Change in tic severity (motor and/or vocal tics) from week 0 (pre treatment) to week 10 (post treatment), 3 months follow up (after post treatment), 6 months follow up and 12 months follow up.
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary outcomes (16)
Clinical Global Impression - Severity (CGI-S)
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Clinical Global Impression - Improvement (CGI-I)
Measured: Week 10; 3 months follow up; 6 months follow up; 12 months follow up
Children's Global Assessment Scale (C-GAS)
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Parent Tic Questionnaire (PTQ)
Measured: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Premonitory urge for Tics Scale (PUTS)
Measured: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL).
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Obsessive-Compulsive Inventory - Child version (OCI-CV).
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Children's Depression Inventory - Short version (CDI-S), with additional suicidality item
Measured: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Mood and Feeling Questionnaire - Short version (MFQ)
Measured: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Measured: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Treatment credibility scale
Measured: Week 3
Treatment satisfaction scale
Measured: Week 10
Safety Monitoring Uniform Report Form (SMURF)
Measured: Week 5; week 10
Internet Intervention Patient Adherence Scale (iiPAS)
Measured: Week 5; week 10
Parental strategy scale
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette's DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mataix-Cols, Karolinska Institutet
- Investigators
- David Mataix-Cols, Professor, Principal investigator, Karolinska Institutet, Department of Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864589
- Sponsor's protocol ID
- 2015/938-31/4
- Status last verified
- Mar 2018
- First submitted
- 9 Aug 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.
PubMed 30772854
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02864589
- Acronym / sponsor ID
- 2015/938-31/4
- Keywords
- Tourette, Tic, Tics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Aug 2016 (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 purpose of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
Detailed description
The primary objective of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD). The two modalities of IBT are habit reversal training (HRT) and exposure and response prevention (ERP). Secondary objectives are to evaluate whether IBT can decrease tic frequency and tic-related impairment, and, as both HRT and ERP have been proven efficacious in treating TD/PTD face-to-face, are any of the two treatments better suited to be delivered via the internet?
The design of the study is a randomized-controlled trial with 20 participants. Participants will be stratified by ADHD/ADD status.
The treatment duration is 10 weeks.
Feasibility and acceptability will be assumed if:
- The two treatments can be successfully adapted to a therapist guided internet-delivered format (technical feasibility)
- Patients/parents are willing to try the offered treatment modalities
- Participants complete the active parts of the treatment
- Referrers are open to the idea of internet-delivered treatment for TD or PTD
- We can recruit sufficient numbers of patients for a fully powered efficacy trial
Regarding the secondary objective, the primary outcome is tic severity measured by the Yale Global Tic Severity Scale (YGTSS). Participants will be assessed directly after treatment (post), and at 3, 6 and 12 months after treatment. Assessments at post-treatment and 3 month follow up will be performed by assessors blinded to the treatment condition. After 3 months, we will naturalistically follow up patients up to 12 months after the end of treatment. Data collection will finish 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-HRT | Experimental | Behavioral: Internet-delivered habit reversal trainingInternet-delivered habit reversal training |
| I-ERP | Experimental | Behavioral: Internet-delivered exposure and response preventionInternet-delivered exposure and response prevention |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Fulfill DSM-5 diagnostic criteria for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
- >15 (TD) or >10 (PTD) on Yale Global Tic Severity Scale (Impairment not included).
- Both child and parent are able to read and communicate in Swedish.
- Regular access to a computer and the Internet.
- Parent availability to support their child throughout the treatment.
Key exclusion criteria (6 listed)
- Acute psychiatric problems such as severe depression, suicidal risk, substance abuse or another psychiatric disorder that could interfere with treatment.
- Lifetime history of global learning disability, pervasive developmental disorder, psychosis, bipolar disorder or organic brain disorder.
- Severe tics causing immediate risk to the patients or others and requiring urgent medical attention.
- Previous behavioural therapy (HRT or ERP), minimum 8 sessions with qualified therapist, within the last 12 months prior to assessment.
- Simultaneous psychological treatment for tic disorder.
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 |
|---|---|---|
| Internet-delivered habit reversal trainingAlso: HRT, HRThe I-HRT group will receive a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on habit reversal training (i.e. Woods, D.W. (2008). Managing Tourette syndrome: A behavioral intervention for children and adults therapist guide. OUP, USA.) with added interactive features as videos and illustrations. In short, the participants practice to become more aware of their tics and inhibit them by performing competing responses (movements). The treatment is therapist guided: the participants have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content. | Behavioural | I-HRT |
| Internet-delivered exposure and response preventionAlso: ERPThe I-ERP group receives a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on exposure and response prevention (i.e. Verdellen, C. et al. (2011). Tics: Therapist manual \& workbook for children. Boom, Amsterd.) with added interactive features as videos and illustrations. In short, the participants practice to suppress their tics for longer and longer times, at the same time as premonitory urges are intentionally provoked. The treatment is therapist-guided: the children and parents have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content. | Behavioural | I-ERP |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Change in tic severity (motor and/or vocal tics) from week 0 (pre treatment) to week 10 (post treatment), 3 months follow up (after post treatment), 6 months follow up and 12 months follow up.
16 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 10; 3 months follow up; 6 months follow up; 12 months follow up
Children's Global Assessment Scale (C-GAS)
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Parent Tic Questionnaire (PTQ)
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Premonitory urge for Tics Scale (PUTS)
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL).
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Obsessive-Compulsive Inventory - Child version (OCI-CV).
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Children's Depression Inventory - Short version (CDI-S), with additional suicidality item
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Mood and Feeling Questionnaire - Short version (MFQ)
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Treatment credibility scale
Time frame: Week 3
Treatment satisfaction scale
Time frame: Week 10
Safety Monitoring Uniform Report Form (SMURF)
Time frame: Week 5; week 10
Internet Intervention Patient Adherence Scale (iiPAS)
Time frame: Week 5; week 10
Parental strategy scale
Time frame: Week 10
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 6 Mar 2018.
- Derived from this study: PubMed 30772854Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.
- Individual participant dataSharing planned: Undecided
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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.
David Mataix-Cols, Professor principal investigator
Karolinska Institutet, Department of Clinical Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered habit reversal training and Internet-delivered exposure and response prevention in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 6 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 6 Mar 2018. 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 Sweden. 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?
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?
Yale Global Tic Severity Scale (YGTSS) (time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up). 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 NCT02864589, which also lists 1 linked publication.
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 6 Mar 2018.