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Mental health
Protocol
Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents—‘Online Remote Behavioural Intervention for Tics’ (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial
  1. Charlotte Lucy Hall1,
  2. E Bethan Davies2,
  3. Per Andrén3,
  4. Tara Murphy4,
  5. Sophie Bennett5,
  6. Beverley J Brown2,
  7. Susan Brown2,
  8. Liam Chamberlain6,
  9. Michael P Craven2,
  10. Amber Evans7,
  11. Cristine Glazebrook8,
  12. Isobel Heyman9,
  13. Rachael Hunter10,
  14. Rebecca Jones11,
  15. Joseph Kilgariff12,
  16. Louise Marston13,
  17. David Mataix-Cols14,
  18. Elizabeth Murray15,
  19. Charlotte Sanderson16,
  20. Eva Serlachius17,
  21. Chris Hollis18
  22. On behalf of the ORBIT Trial team.
    1. 1 Trial Manager, Institute of Mental Health, University of Nottingham, Nottingham, UK
    2. 2 Research Fellow and Trial Therapist, NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK
    3. 3 Clinical Psychologist, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Health Care Services, Stockholm, Sweden
    4. 4 Consultant Psychologist, University College London, Hospital for Children NHS Foundation Trust, London, UK
    5. 5 Senior Research Fellow, University College London, Hospital for Children NHS Foundation Trust, London, UK
    6. 6 Trial Therapist, Division of Psychiatry and Applied Psychology, University of Nottingham, Queen’s Medical Centre, Nottingham, UK
    7. 7 Trial Therapist, University College London, Hospital for Children NHS Foundation Trust, Nottingham, UK
    8. 8 Professor of Health Psychology, Division of Psychiatry and Applied Psychology, Institute of Mental Health, Nottingham, UK
    9. 9 Consultant Psychiatrist, Hospital for Children NHS Foundation Trust, London, UK
    10. 10 Health Economist, Research Department of Primary care and Population health and Priment CTU, University College London, London, UK
    11. 11 Senior Research Associate, Research Department of Primary care and Population health and Priment CTU, University College London, London, UK
    12. 12 Advanced Nurse, Division of Psychiatry and Applied Psychology, University of Nottingham, Queen’s Medical Centre, Nottingham, UK
    13. 13 Principal Research Associate, Research Department of Primary care and Population Health and Priment CTU, University College London, London, UK
    14. 14 Professor of Child and Adolescent Psychiatric Science, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden and Stockholm Health Care Services, London, UK
    15. 15 Professor of eHealth and Primary Care, eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, Sweden
    16. 16 Research Clinical Psychologist, University College London, London, UK
    17. 17 Assistant Professor in Child and Adolescent Psychiatry, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
    18. 18 Queens Medical Centre, Professor of Child and Adolescent Psychiatry, Developmental Psychiatry, University of Nottingham, Nottingham, UK
    1. Correspondence to Professor Chris Hollis; chris.hollis{at}nottingham.ac.uk

    Abstract

    Introduction Tourette syndrome and chronic tic disorder are common, disabling childhood-onset conditions. Guidelines recommend that behavioural therapy should be offered as first-line treatment for children with tics. However, there are very few trained behaviour therapists for tics and many patients cannot access appropriate care. This trial investigates whether an internet-delivered intervention for tics can reduce severity of symptoms.

    Methods and analysis This parallel-group, single-blind, randomised controlled superiority trial with an internal pilot will recruit children and young people (aged 9–17 years) with tic disorders. Participants will be randomised to receive 10 weeks of either online, remotely delivered, therapist-supported exposure response prevention behavioural therapy for tics, or online, remotely delivered, therapist-supported education about tics and co-occurring conditions. Participants will be followed up mid-treatment, and 3, 6, 12 and 18 months post randomisation.

    The primary outcome is reduction in tic severity as measured on the Yale Global Tic Severity Scale total tic severity score. Secondary outcomes include a cost-effectiveness analysis and estimate of the longer-term impact on patient outcomes and healthcare services. An integrated process evaluation will analyse quantitative and qualitative data in order to fully explore the implementation of the intervention and identify barriers and facilitators to implementation. The trial is funded by the National Institute of Health Research (NIHR), Health Technology Assessment (16/19/02).

    Ethics and dissemination The findings from the study will inform clinicians, healthcare providers and policy makers about the clinical and cost-effectiveness of an internet delivered treatment for children and young people with tics. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref.: 18/NW/0079).

    Trial registration numbers ISRCTN70758207 and NCT03483493; Pre-results.

    • behaviour therapy
    • exposure and response prevention
    • internet
    • persistent (chronic) motor or vocal tic disorder
    • tourette’s disorder

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    http://dx.doi.org/10.1136/bmjopen-2018-027583

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      Footnotes

      • Patient consent for publication None required.

      • Contributors CH is the chief investigator and takes final responsibility for study design, conduct and decision to submit for publication. The study design was conceived and written by CH, CLH (trial manager), PA, TM, DM-C, EM, LM, MPC, IH, ES, RJ, RH and CG (co-investigators). CLH wrote the protocol manuscript with approval from all authors. LM and RJ (statisticians) designed and wrote the statistical analysis plan. RH (health economist and co-investigator) designed and wrote the health economic plan. CG leads on the process evaluation. EBD (therapist) and TM and JK lead on delivery and design of the therapy. SuB (co-investigator) leads on PPI. JK, MPC, IH, SoB and CS and BJB (researchers) and AE and LC (therapists) provided advice and critical input on the study design. All authors critically revised the manuscript for its important intellectual content. All authors read and approved the final manuscript.

      • Funding This research was funded by the NIHR Heath Technology Assessment (HTA) (Ref 16/19/02). MPC, SB, EBD, CG and CH acknowledge the financial support of the NIHR Nottingham Biomedical Research Centre and NIHR MindTech MedTech Co-operative.

      • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and social care. The study sponsor and funders have no role in study design, including collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

      • Competing interests None declared.

      • Ethics approval The initial protocol (V.2.0, 26 February 2018) was approved by North West Greater Manchester Research Ethics Committee (REC reference 18/NW/0079) on 23 March 2018. A subsequent amendment (V.3.0, 16 April 2018) was approved by the committee on 15 May 2018 to allow the 10-week intervention to be delivered over a 12-week period to account for periods of therapist absence during bank holidays or unforeseen circumstances.

      • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

      • Collaborators ORBIT Trial Team: Robin Carpenter; Caitlin Hand; Anne Marie Downey; Kareem Khan; Natalia Lago; Jennifer L Martin; Roz Shafran.