Therapist-Supported Online Remote Behavioural Intervention for Tics (ORBIT) in Children and Adolescents: A Single-Blind Randomised Controlled Trial

Background: Behaviour therapy is an effective treatment in children and adolescents with tic disorders but is rarely available. Online delivery could widen access to therapy. We evaluated the efficacy of internet-delivered, therapist-supported and parent-assisted Exposure and Response Prevention (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, 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 and health care costs were calculated. Registrations are ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493). Findings: Between 8 th May 2018 and 30 th September 2019, 224 participants were enrolled; 112 to ERP and 112 to psychoeducation. The ERP intervention reduced YGTSS-TTSS by 2 . 29 points (95% CI: ‑3 . 86 to -0 . 71) compared to the psychoeducation group 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: Online-delivered, therapist-supported ERP therapy is clinically effective at reducing tics, with minimal therapist contact time. Online delivery could improve access to evidence-based treatment for tics in children and adolescents. Trial Registration: Registrations are ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493). Funding: National Institute for Health Research, Health and Technology Assessment (HTA) Declaration of Interest: All authors have completed the ICMJE uniform disclosure from. Aside from receiving funding from NIHR to support their salaries CLH, LM, EBD, RJ, KK, BJB, CS, CM, ES, PA, TM, IS, JK, RH, MLN, AE, LRC, NK, SB, CG, EM declare no conflict of interests. CH declares he was Principal Investigator on a grant from the National Institute of Health Research (NIHR) Health Technology Assessment programme to conduct an Evidence Synthesis on the treatments for tics and Tourette syndrome in children and young people’ HTA Project:10/142/01. DM-C reports personal fees from Elsevier, personal fees from UpToDate Inc. outside the submitted work. Ethical Approval: Ethical and Health Research Authority (HRA) approval was received from North West Greater Manchester Research Ethics Committee on 23 March 2018 (ref.:18/NW/0079). The published trial protocol is available online15 and was approved by an independent trial steering committee (TSC) and data monitoring committee (DMC). Two substantial amendments were made and can be found in the appendix p1. The trial was prospectively registered with the ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493).