An interventional study of Internet-delivered habit reversal training and Internet-delivered exposure and response prevention in Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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).
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:
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.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 23 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Internet-delivered habit reversal training
Behavioral: Internet-delivered habit reversal training
Internet-delivered exposure and response prevention
Behavioral: Internet-delivered exposure and response prevention
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.
Also known as: HRT, HR
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.
Also known as: ERP
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.
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
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
Plan to share: Undecided
The record gives a start of Aug 2016, a primary completion of Jan 2018 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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