BUP CPF
Stockholm, 113 30, Sweden
NCT Number: NCT02864589
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).
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Notify Me7 year–17 year
All sexes
Interventional
Not applicable
Stockholm, 113 30, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: ERP
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.
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Time frame: Week 3
Time frame: Week 10
Time frame: Week 5; week 10
Time frame: Week 5; week 10
Time frame: Week 10
Karolinska Institutet
Other
Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study
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