Online remote behavioural intervention for tics in 9- to 17-year-olds : the ORBIT RCT with embedded process and economic evaluation
(2023) In Health Technology Assessment 27(18). p.1-120- Abstract
BACKGROUND: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online.
OBJECTIVE: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders.
DESIGN: 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... (More)
BACKGROUND: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online.
OBJECTIVE: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders.
DESIGN: 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.
SETTING: Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals.
PARTICIPANTS: 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.
INTERVENTIONS: Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control).
OUTCOME: 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.
RESULTS: Two hundred and twenty-four participants were randomised to the intervention (n = 112) or control (n = 112) group. Participants were mostly male (n = 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 the mean incremental cost per participant of the intervention compared to the control was £662 (95% confidence interval -£59 to £1384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval -0.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was £16,708. The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes.
HARMS: Two serious, unrelated adverse events occurred in the control group.
LIMITATIONS: 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.
CONCLUSION: 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.
FUTURE WORK: Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice.
TRIAL REGISTRATION: This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete.
FUNDING: 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 Health and Technology Assessment; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.
(Less)
- author
- organization
- publishing date
- 2023-10
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Child, Humans, Male, Adolescent, Female, Tics, Cost-Benefit Analysis, Single-Blind Method, Tic Disorders, Behavior Therapy, Quality of Life
- in
- Health Technology Assessment
- volume
- 27
- issue
- 18
- pages
- 1 - 120
- publisher
- National Co-ordinating Centre for HTA
- external identifiers
-
- scopus:85176499182
- pmid:37924247
- ISSN
- 1366-5278
- DOI
- 10.3310/CPMS3211
- language
- English
- LU publication?
- yes
- id
- 0dd1cb0a-916d-449e-be7a-3f69727e3658
- date added to LUP
- 2023-11-10 13:54:14
- date last changed
- 2024-04-23 21:39:28
@article{0dd1cb0a-916d-449e-be7a-3f69727e3658,
abstract = {{<p>BACKGROUND: Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online.</p><p>OBJECTIVE: To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported therapy for young people with tic disorders.</p><p>DESIGN: 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.</p><p>SETTING: Two hospitals (London and Nottingham) in England also accepting referrals from patient identification centres and online self-referrals.</p><p>PARTICIPANTS: 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.</p><p>INTERVENTIONS: Either 10 weeks of online, remotely delivered, therapist-supported exposure and response prevention therapy (intervention group) or online psychoeducation (control).</p><p>OUTCOME: 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.</p><p>RESULTS: Two hundred and twenty-four participants were randomised to the intervention (n = 112) or control (n = 112) group. Participants were mostly male (n = 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 the mean incremental cost per participant of the intervention compared to the control was £662 (95% confidence interval -£59 to £1384), with a mean incremental quality-adjusted life-year of 0.040 (95% confidence interval -0.004 to 0.083) per participant. The mean incremental cost per quality-adjusted life-year gained was £16,708. The intervention was acceptable and delivered with high fidelity. Parental engagement predicted child engagement and more positive clinical outcomes.</p><p>HARMS: Two serious, unrelated adverse events occurred in the control group.</p><p>LIMITATIONS: 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.</p><p>CONCLUSION: 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.</p><p>FUTURE WORK: Future work should compare online to face-to-face therapy and explore how to embed the intervention in clinical practice.</p><p>TRIAL REGISTRATION: This trial is registered as ISRCTN70758207; ClinicalTrials.gov (NCT03483493). The trial is now complete.</p><p>FUNDING: 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 Health and Technology Assessment; Vol. 27, No. 18. See the NIHR Journals Library website for further project information.</p>}},
author = {{Hollis, Chris and Hall, Charlotte L and Khan, Kareem and Le Novere, Marie and Marston, Louise and Jones, Rebecca and Hunter, Rachael and Brown, Beverley J and Sanderson, Charlotte and Andrén, Per and Bennett, Sophie D and Chamberlain, Liam R and Davies, E Bethan and Evans, Amber and Kouzoupi, Natalia and McKenzie, Caitlin and Heyman, Isobel and Kilgariff, Joseph and Glazebrook, Cristine and Mataix-Cols, David and Serlachius, Eva and Murray, Elizabeth and Murphy, Tara}},
issn = {{1366-5278}},
keywords = {{Child; Humans; Male; Adolescent; Female; Tics; Cost-Benefit Analysis; Single-Blind Method; Tic Disorders; Behavior Therapy; Quality of Life}},
language = {{eng}},
number = {{18}},
pages = {{1--120}},
publisher = {{National Co-ordinating Centre for HTA}},
series = {{Health Technology Assessment}},
title = {{Online remote behavioural intervention for tics in 9- to 17-year-olds : the ORBIT RCT with embedded process and economic evaluation}},
url = {{http://dx.doi.org/10.3310/CPMS3211}},
doi = {{10.3310/CPMS3211}},
volume = {{27}},
year = {{2023}},
}