Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation

• Published in: Health technology assessment (Winchester, England) England), 2023-10, Vol.27 (18), p.1-120
• Main Authors: Hollis, Chris, Hall, Charlotte L, Khan, Kareem, Le Novere, Marie, Marston, Louise, Jones, Rebecca, Hunter, Rachael, Brown, Beverley J, Sanderson, Charlotte, Andrén, Per, Bennett, Sophie D, Chamberlain, Liam R, Davies, E Bethan, Evans, Amber, Kouzoupi, Natalia, McKenzie, Caitlin, Heyman, Isobel, Kilgariff, Joseph, Glazebrook, Cristine, Mataix-Cols, David, Serlachius, Eva, Murray, Elizabeth, Murphy, Tara
• Format: Article
• Language: English
• Subjects: Adolescent; Behavior Therapy; behaviour therapy; Child; Clinical Medicine; Cost-Benefit Analysis; digital health; exposure response prevention; Female; Health Care Service and Management, Health Policy and Services and Health Economy; health economic evaluation; Health Sciences; Humans; Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi; Hälsovetenskap; Klinisk medicin; Male; Medical and Health Sciences; Medicin och hälsovetenskap; online; process evaluation; Psychiatry; Psykiatri; Quality of Life; randomised controlled trial; Single-Blind Method; tic disorder; Tic Disorders; Tics; tourette syndrome
• ISSN: 1366-5278; 2046-4924; 2046-4924
• DOI: 10.3310/CPMS3211

Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders. 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. Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals. Children aged 9-17 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 > 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. Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control). 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. Two hundred and twenty-four participants were randomised to the intervention ( = 112) or control ( = 112) group. Participants were mostly male ( = 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 -2.29 points (95% confidence interval -3.86 to -0.71) in favour of therapy (effect size -0.31, 95% confidence interval -0.52 to -0.10). This effect was sustained throughout to the final follow-up at 18 months (-2.01 points, 95% confidence interval -3.86 to -0.15; effect size -0.27, 95% confidence interval -0.52 to -0.02). At 18 months