{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T01:07:18Z","timestamp":1778029638242,"version":"3.51.4"},"reference-count":150,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T00:00:00Z","timestamp":1696118400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["16\/19\/02"],"award-info":[{"award-number":["16\/19\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title>\n<jats:p>To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title>\n<jats:p>Single-blind, parallel-group, randomised controlled trial, with 3-month (primary end point) and 6-month post-randomisation follow-up. Participants were individually randomised (1 : 1), using on online system, with block randomisations, stratified by site. Naturalistic follow-up was conducted at 12 and 18 months post-randomisation when participants were free to access non-trial interventions. A subset of participants participated in a process evaluation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title>\n<jats:p>Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title>\n<jats:p>Children aged 9\u201317 years (1) with Tourette syndrome or chronic tic disorder, (2) with a Yale Global Tic Severity Scale-total tic severity score of 15 or more (or &gt; 10 with only motor or vocal tics) and (3) having not received behavioural therapy for tics in the past 12 months or started\/stopped medication for tics within the past 2 months.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title>\n<jats:p>Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Outcome<\/jats:title>\n<jats:p>Primary outcome: Yale Global Tic Severity Scale-total tic severity score 3 months post-randomisation; analysis done in all randomised patients for whom data were available. Secondary outcomes included low mood, anxiety, treatment satisfaction and health resource use. Quality-adjusted life-years are derived from parent-completed quality-of-life measures. All trial staff, statisticians and the chief investigator were masked to group allocation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title>\n<jats:p>Two hundred and twenty-four participants were randomised to the intervention (<jats:italic>n<\/jats:italic> = 112) or control (<jats:italic>n<\/jats:italic> = 112) group. Participants were mostly male (<jats:italic>n<\/jats:italic> = 177; 79%), with a mean age of 12 years. At 3 months the estimated mean difference in Yale Global Tic Severity Scale-total tic severity score between the groups adjusted for baseline and site was \u22122.29 points (95% confidence interval \u22123.86 to \u22120.71) in favour of therapy (effect size \u22120.31, 95% confidence interval \u22120.52 to \u22120.10). This effect was sustained throughout to the final follow-up at 18 months (\u22122.01 points, 95% confidence interval \u22123.86 to \u22120.15; effect size \u22120.27, 95% confidence interval \u22120.52 to \u22120.02).<\/jats:p>\n<jats:p>At 18 months the mean incremental cost per participant of the intervention compared to the control was \u00a3662 (95% confidence interval \u2212\u00a359 to \u00a31384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval \u22120.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was \u00a316,708.<\/jats:p>\n<jats:p>The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Harms<\/jats:title>\n<jats:p>Two serious, unrelated adverse events occurred in the control group.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Limitations<\/jats:title>\n<jats:p>We cannot separate the effects of digital online delivery and the therapy itself. The sample was predominately white and British, limiting generalisability. The design did not compare to face-to-face services.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Conclusion<\/jats:title>\n<jats:p>Online, therapist-supported behavioural therapy for young people with tic disorders is clinically and cost-effective in reducing tics, with durable benefits extending up to 18 months.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Future work<\/jats:title>\n<jats:p>Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-14\"><jats:title>Funding<\/jats:title>\n<jats:p>This project was funded by the National Institute for Health and Care Research (NIHR) Health and Technology Assessment programme (project number 16\/19\/02) and will be published in full in <jats:italic>Health and Technology Assessment<\/jats:italic>; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/cpms3211","type":"journal-article","created":{"date-parts":[[2023,11,4]],"date-time":"2023-11-04T08:36:09Z","timestamp":1699086969000},"page":"1-120","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1083-6744","authenticated-orcid":true,"given":"Chris","family":"Hollis","sequence":"first","affiliation":[{"name":"NIHR MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5412-6165","authenticated-orcid":true,"given":"Charlotte 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