Therapist-supported online remote behavioural intervention for tics in children and adolescents in England (ORBIT): a multicentre, parallel group, single-blind, randomised controlled trial

Abstract

Background: Exposure and Response Prevention (ERP) for tics appears a promising form of behaviour therapy for online delivery which could widen access to treatment. However, the effectiveness of ERP in general, and in particular when delivered online, remains uncertain. We evaluated the effectiveness of internet-delivered, therapist-supported and parent-assisted ERP for tics. Methods: Multi-centre, parallel group, single-blind, randomised controlled trial. Eligible participants were aged 9-17 years with Tourette syndrome/chronic tic disorder, who had not received behaviour therapy for tics within 12 months, and had a Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) of >15, or >10 if motor or vocal tics only. Participants were recruited via 16 patient identification centres, two study sites in England (Nottingham and London), or online self-referral, and were randomised (1:1) by blinded outcome-assessors to receive either 10 weeks of ERP or psychoeducation (active control). The primary outcome was YGTSS-TTSS at 3 months’ post-randomisation, analysis was by intention-to-treat. The mean cost per patient for the intervention were calculated. Longer term follow-ups are still on-going. Registrations are ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493). Findings: Between 8th May 2018 and 30th September 2019, 224 participants were enrolled; 112 to ERP and 112 to psychoeducation. The sample was predominately male (177; 79%) and of white ethnicity (195; 87%). The difference between the groups on the YGTSS-TTSS was -2.29 points (95% CI: -3.86 to -0.71), a reduction favouring the ERP intervention at 3 months, an effect that increased by 6 months post-randomisation (-2.64, 95% CI: -4.56 to -0.73). The average therapist time spent supporting the intervention was 2.5 hours. The additional cost per participant of the ERP intervention compared to psychoeducation was £159 (95% CI -£53 to £370). There were two unrelated serious adverse events, both in the psychoeducation group. Interpretation: ERP is an effective behavioural therapy for tics. Digitally enabled ERP with minimal therapist contact time represents an efficient public mental health approach to improve access to behavioural therapy for tics in children and adolescents.