An interventional study of Exposure and response prevention (ERP) and Education on tics 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 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
The purpose of this trial is to evaluate the clinical efficacy, 12-month durability, and cost-effectiveness of BIP TIC - a therapist-guided and parent-guided internet-delivered behavioural intervention for children and adolescents with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder.
Primary objective: To determine the clinical efficacy of BIP TIC (Andrén et al., 2019; a therapist-guided and parent-guided, internet-delivered behavioural intervention for Tourette's Disorder (TD) and Persistent (Chronic) Motor or Vocal Tic Disorder (PTD), for reducing tic severity (as measured by the primary outcome variable Yale Global Tic Severity Scale [YGTSS] Total Tic Severity Score [TTSS]) in children and adolescents with TD/PTD, compared with a control intervention (therapist-guided and parent-guided internet-delivered education on tics).
Secondary objectives: To establish the 12-month durability of the treatment effects, and to assess the cost-effectiveness of BIP TIC, compared with therapist-guided and parent-guided internet-delivered education on tics, from a societal perspective.
Type of trial: Single-blind parallel-group randomised controlled superiority trial.
Trial design and methods: All potential participants are initially screened via the telephone, or in some cases at the clinic. This is followed by an inclusion assessment conducted either at the clinic or via the videoconference software Zoom. Participants who are eligible and have consented will be randomised into one of two trial arms. In the experimental arm, participants receive 10 weeks of therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP). In the control arm, participants receive 10 weeks of therapist-guided and parent-guided internet-delivered education on tics. Participants will complete outcome measures at baseline, mid-treatment (3 and 5 weeks post-baseline), post-treatment (10-weeks post-baseline) and 3, 6 and 12 months post-treatment. To allow for holidays or periods of sick leave, it is possible to extend the duration of the treatment from 10 to a maximum of 12 weeks (of which only 10 weeks will include therapist support). In these cases, the listed time frames in the "Outcome Measures" section will be extended with the equivalent number of weeks.
The primary outcome variable is the Total Tic Severity Score (TTSS) of the Yale Global Tic Severity Scale (YGTSS), and the primary endpoint is the follow-up 3-months post-treatment. For secondary outcomes, see section below. Follow-up assessments will be conducted at the clinic or via Zoom videoconference software, in both cases complemented with online questionnaires.
Planned trial sites: All assessments and delivery of treatment will be administrated from a single site in Stockholm, the Child and Adolescent Psychiatry Research Center. Several collaborating counties all across Sweden will assist on referring potential participants to the Stockholm site for inclusion in the trial.
Sample: 220 participants.
Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 221 is above 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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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.
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.
Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP)
Behavioral: Exposure and response prevention (ERP)
Therapist-guided and parent-guided internet-delivered education on tics
Behavioral: Education on tics
The intervention consists of 10 modules/chapters for children/adolescents, delivered over 10. Each of the 10 modules includes age-appropriate texts, animations and exercises. The intervention is primarily based on ERP techniques. During the treatment, participants are instructed to practice suppressing their tics, this is known as 'response prevention'. Then, with the help of their caregiver/parent, the participant is instructed to provoke premonitory urges (a sensation usually felt before a tic is expressed), while still suppressing tics, which is known as 'exposure'. The parent is provided with her/his own separate login to the internet platform, which consists of 10 separate modules/chapters. The parent intervention consists mainly of information regarding parent coping strategies, social support and functional analysis relating to tics. Both the child/adolescent and the parent have individual access to the same therapist.
Also known as: BIP TIC
The active comparator is designed to match the experimental intervention in all aspects except for the module content (same platform, same treatment length, same therapist support etc.). The intervention consists mainly of psychoeducational information about TD/PTD and common comorbid conditions, and reviews the definition of tics, natural history, common presentations, prevalence, aetiology, risks and protective factors, strategies for describing tics to other people, among others. Problem-solving and development of expertise in tic disorders is emphasised. The intervention does not include any information on ERP or functional analysis and interventions. As in the experimental intervention, the parent is provided with her/his own separate login to the internet platform. The parent intervention consists mainly of information regarding parent coping strategies and social support. Both the child and the parent have individual access to the same therapist.
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS)
Change in tic severity (motor and/or vocal tics) (range 0-50 points) from week 0 (baseline) to week 10 (post-treatment), 3-month follow-up (after post-treatment), 6-month follow-up and 12-month follow-up. The primary endpoint is the 3-month follow-up. The TTSS can also be divided into separate severity scores for motor tics (range 0-25 points) and vocal tics (range 0-25 points). When summed, these two scores comprise the TTSS (range 0-50 points). A higher value represents a greater tic severity. Clinician-rated, semi-structured interview.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Yale Global Tic Severity Scale (YGTSS) Impairment
Impairment score (range 0-50 points) of the YGTSS. Used to assess tic specific impairment. Clinician-rated, semi-structured interview.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Clinical Global Impression - Severity (CGI-S)
Used to provide an overall rating of the tic disorder severity. Clinician-rated.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Clinical Global Impression - Improvement (CGI-I)
Used to assess global improvement. Clinician-rated. Treatment response in the trial is operationalised as scores of "very much improved" (1) or "much improved" (2) on the CGI-I.
Time frame: Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Children's Global Assessment Scale (CGAS)
Used to assess global improvement. Clinician-rated.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
internet intervention Patient Adherence Scale (iiPAS)
Used to assess the child/adolescent's adherence to the internet-delivered treatment. Clinician-rated.
Time frame: Mid-treatment (5 weeks post-baseline); week 10.
Therapist platform time
Therapist platform time is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10.
Therapist telephone time
Therapist telephone time is manually logged in a spreadsheet throughout the trial. Separate data for children and parents.
Time frame: Week 10.
Number of completed chapters in the internet treatment platform
Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10.
Number of logins to the internet treatment platform
Number of logins is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10; 12-month follow-up.
Average time between logins to the internet treatment platform
Average time between logins is automatically logged in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10.
Average pages visited in the internet treatment platform
Average pages visited in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10.
Number of characters submitted in the internet treatment platform
Number of characters submitted in the internet treatment platform. Separate data for children and parents.
Time frame: Week 10.
The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Scale (C&A-GTS-QOL)
Used to assess disease-specific health-related quality of life. Two different versions will be used, one for participants aged 9-12, and one for participants aged 13-17. Child/adolescent-reported.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Short Mood and Feeling Questionnaire - child version (SMFQ) + additional suicide item
Used to assess depressive symptoms and suicidal ideation. Child/adolescent-reported.
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Obsessive-compulsive inventory - child version (OCI-CV)
Used to assess obsessive-compulsive symptoms. Child/adolescent-reported.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Treatment credibility questionnaire
Questionnaire developed by the research team. Used to assess treatment credibility. Separate versions for the child/adolescent and the parent are used.
Time frame: Mid-treatment (3 weeks post-baseline).
Working alliance inventory - child and parent versions (WAI-C and WAI-P )
Used to assess the child/adolescent/parent's perceived working alliance with their therapist. Separate versions for the child/adolescent and the parent are used.
Time frame: Mid-treatment (3 weeks post-baseline).
Treatment satisfaction questionnaire
Questionnaire developed by the research team. Used to assess treatment satisfaction. Separate versions for the child/adolescent and the parent are used.
Time frame: 3-month follow-up.
KIDSCREEN-10
Used to assess quality of life, with the intention to transform this data into quality adjusted lifetime years (QALYs). Separate versions for the child/adolescent and the parent are used.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Parent Tic Questionnaire (PTQ)
Used to assess tic severity. Parent-reported.
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Short Mood and Feeling Questionnaire - parent version (SMFQ)
Used to assess depressive symptoms. Parent-reported.
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Side effects questionnaire
Used to assess side effects/adverse events for the child/adolescent. Parent-reported.
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up.
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Used to assess healthcare and societal resource use. Parent-reported.
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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