Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome: 12-Month Follow-Up of a Randomized Clinical Trial.

Importance: Behavior therapy is a recommended intervention for Tourette syndrome (TS) and chronic tic disorder (CTD), but availability is limited and long-term effects are uncertain. Objective: To investigate the long-term efficacy and cost-effectiveness of therapist-supported, internet-delivered exposure and response prevention (ERP) vs psychoeducation for youths with TS or CTD. Design, Setting, And Participants: This 12-month controlled follow-up of a parallel group, superiority randomized clinical trial was conducted at a research clinic in Stockholm, Sweden, with nationwide recruitment. In total, 221 participants aged 9 to 17 years with TS or CTD were enrolled between April 26, 2019, and April 9, 2021, of whom 208 (94%) provided 12-month follow-up data. Final follow-up data were collected on June 29, 2022. Outcome assessors were masked to treatment allocation throughout the study. Interventions: A total of 111 participants were originally randomly allocated to 10 weeks of therapist-supported, internet-delivered ERP and 110 participants to therapist-supported, internet-delivered psychoeducation. Main Outcomes And Measures: The primary outcome was within-group change in tic severity, measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS), from the 3-month follow-up to the 12-month follow-up. Treatment response was defined as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale. Analyses were intention-to-treat and followed the plan prespecified in the published study protocol. A health economic evaluation was performed from 3 perspectives: health care organization (including direct costs for treatment provided in the study), health care sector (additionally including health care resource use outside of the study), and societal (additionally including costs beyond health care [eg, parent's absenteeism from work]). Results: In total, 221 participants were recruited (mean [SD] age, 12.1 [2.3] years; 152 [69%] male). According to the YGTSS-TTSS, there were no statistically significant changes in tic severity from the 3-month to the 12-month follow-up in either group (ERP coefficient, -0.52 [95% CI, -1.26 to 0.21]; P = .16; psychoeducation coefficient, 0.00 [95% CI, -0.78 to 0.78]; P > .99). A secondary analysis including all assessment points (baseline to 12-month follow-up) showed no statistically significant between-group difference in tic severity from baseline to the 12-month follow-up (coefficient, -0.38 [95% CI, -1.11 to 0.35]; P = .30). Treatment response rates were similar in both groups (55% in ERP and 50% in psychoeducation; odds ratio, 1.25 [95% CI, 0.73-2.16]; P = .42) at the 12-month follow-up. The health economic evaluation showed that, from a health care sector perspective, ERP produced more quality-adjusted life years (0.01 [95% CI, -0.01 to 0.03]) and lower costs (adjusted mean difference -$84.48 [95% CI, -$440.20 to $977.60]) than psychoeducation at the 12-month follow-up. From the health care organization and societal perspectives, ERP produced more quality-adjusted life years at higher costs, with 65% to 78% probability of ERP being cost-effective compared with psychoeducation when using a willingness-to-pay threshold of US $79 000. Conclusions And Relevance: There were no statistically significant changes in tic severity from the 3-month through to the 12-month follow-up in either group. The ERP intervention was not superior to psychoeducation at any time point. While ERP was not superior to psychoeducation alone in reducing tic severity at the end of the follow-up period, ERP is recommended for clinical implementation due to its likely cost-effectiveness and support from previous literature. Trial Registration: ClinicalTrials.gov Identifier: NCT03916055.

Implementing internet-based cognitive behavioural therapy (moodgym) for African students with symptoms of low mood during the COVID-19 pandemic: a qualitative feasibilty study.

BACKGROUND: Online therapies have been shown to be effective in improving students' mental health. They are cost-effective and therefore have particular advantages in low-income countries like Zambia where mental health resources are limited. This study aimed to explore the perceived impact of the COVID-19 pandemic and the feasibility of implementing an Internet-Based Cognitive Behavioural Therapy (iCBT) intervention ('moodgym') to improve resilience in vulnerable Zambian students. METHODS: The study was a qualitative interview study. Participants identifying as having symptoms of low mood and completing a baseline, online survey (n = 620) had the option to volunteer for a semi-structured interview to explore views about their experience of the pandemic and the acceptability and perceived benefits and limitations of using moodgym. RESULTS: A total of 50 students (n = 24 female, n = 26 male) participated in the study. One theme with 4 sub-themes, captured the severe emotional and social impact of the COVID-19 pandemic. A second, very strong theme, with 5 sub-themes, reflected the considerable negative effects of the pandemic on the students' educational experience. This included the challenges of online learning. The third theme, with three subthemes, captured the benefits and acceptability of moodgym, particularly in terms of understanding the relationship between thoughts and feelings and improving academic performance. The fourth theme described the technical difficulties experienced by students in attempting to use moodgym. CONCLUSION: COVID-19 caused fear and impacted wellbeing in vulnerable students and severely impaired the quality of students' educational experience. The findings suggest that moodgym might be a valuable support to students in a low-income country.

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

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.

It can be difficult for children and young people with tics to access therapy. This is because there are not enough trained tic therapists. Online remote behavioural intervention for tics was a clinical trial to see whether an online platform that delivered two different types of interventions could help tics. One intervention focused on techniques to control tics; this type of therapy is called exposure and response prevention. The other intervention was psychoeducation, where participants learned about the nature of tics but not how to control them. The online remote behavioural intervention for tics interventions also involved help from a therapist and support from a parent. Participants were aged 9­17 years with Tourette syndrome/chronic tic disorder and were recruited from 16 clinics, two study sites (Nottingham and London) or via online self-referral. All individuals who were eligible for the online remote behavioural intervention for tics trial were randomised in a 50/50 split by researchers who were unaware of which treatment was being given. Participants received either 10 weeks of online exposure and response prevention or 10 weeks of online psychoeducation. A total of 224 children and young people participated: 112 allocated to exposure and response prevention and 112 to psychoeducation. Tics decreased more in the exposure and response prevention group (16% reduction) than in the psychoeducation group (6% reduction) 3 months after treatment. This difference is considered a clinically important difference in tic reduction. The treatment continued to have a positive effect on tic symptoms at 6, 12 and 18 months, showing that the effects are durable. This was achieved with minimal therapist involvement. The cost of online exposure and response prevention to treat young people with tics within this study was less when compared to the cost of face-to-face therapy. The results show that exposure and response prevention is an effective behavioural therapy for tics in this specific patient group. Delivering exposure and response prevention online with minimal therapist contact can be a successful and cost-effective treatment to improve access to behavioural therapy.

A systematic review and meta-analysis of studies exploring prevalence of non-specific anxiety in undergraduate university students.

BACKGROUND: Anxiety is a common mental health problem in the general population, and is associated with functional impairment and negative impacts upon quality of life. There has been increased concern about university students' mental health in recent years, with a wide range of non-specific anxiety rates reported worldwide in undergraduate university students. We aimed to explore prevalence of non-specific anxiety in undergraduate university student populations. METHODS: Four databases were searched to identify studies published between 1980 and 2020 which investigated prevalence of non-specific anxiety in undergraduate university students. Each study's quality was appraised using a checklist. Sub-analyses were undertaken reflecting outcome measure utilized, course of study, location of study, and whether study was before or during the COVID-19 pandemic. RESULTS: A total of 89 studies - representing approx. 130,090 students-met inclusion criteria. Eighty-three were included in meta-analysis, calculating a weighted mean prevalence of 39.65% (95% CI: 35.72%-43.58%) for non-specific anxiety. Prevalence from diagnostic interview studies ranged from 0.3%-20.8% 12-month prevalence. Prevalence varied by outcome measure used to assess non-specific anxiety, the type of course studied by sample, and by study location. In half the studies, being female was associated with being more likely to have higher non-specific anxiety scores and/or screening above thresholds. Few of the included studies met all quality appraisal criteria. CONCLUSION: The results suggest that approximately a third of undergraduate students are experiencing elevated levels of non-specific anxiety. Results from sub-analyses have identified some methodological issues that need consideration in appraising prevalence in this population.

Factors influencing COVID-19 health protective behaviours in Zambian university students with symptoms of low mood.

BACKGROUND: Health protective behaviours are crucial in the prevention of the spread of COVID-19, particularly in university students who typically live and study in large groups. Depression and anxiety are common in students and can impact young people's motivations to follow health advice. The study aims to assess the relationship between mental health and COVID-19 health-protective behaviours in Zambian university students with symptoms of low mood. METHODS: The study was a cross-sectional, online survey of Zambian university students. Participants were also invited to take part in a semi-structured interview to explore views about COVID-19 vaccination. Invitation emails were sent explaining the study aims and directed students who self-identified as having low mood in the past two weeks to an online survey. Measures included COVID-19 preventive behaviours, COVID-19-related self-efficacy, and Hospital and Anxiety Depression scale. RESULTS: A total of 620 students (n=308 female, n=306 male) participated in the study, with a mean participant age of 22.47±3.29 years (range 18-51). Students reported a mean protective behaviour score of 74.09/105 and 74% scored above the threshold for possible anxiety disorder. Three-way ANOVA showed lower COVID-19 protective behaviours in students with possible anxiety disorder (p=.024) and those with low self-efficacy (p<0.001). Only 168 (27%) said they would accept vaccination against COVID-19, with male students being twice as likely to be willing to accept COVID-19 vaccination (p<0.001). Of 50 students interviewed. 30 (60%) expressed fears about the vaccination and 16 (32%) were concerned about a lack of information. Only 8 (16%) participants expressed doubts about effectiveness. CONCLUSION: Students who self-identify as having symptoms of depression have high levels of anxiety. The results suggest that interventions to reduce anxiety and promote self-efficacy might enhance students' COVID-19 protective behaviours. Qualitative data provided insight into the high rates of vaccine hesitancy in this population.

Long-term clinical and cost-effectiveness of a therapist-supported online remote behavioural intervention for tics in children and adolescents: extended 12- and 18-month follow-up of a single-blind randomised controlled trial.

BACKGROUND: Little is known about the long-term effectiveness of behavioural therapy for tics. We aimed to assess the long-term clinical and cost-effectiveness of online therapist-supported exposure and response prevention (ERP) therapy for tics 12 and 18 months after treatment initiation. METHODS: ORBIT (online remote behavioural intervention for tics) was a two-arm (1:1 ratio), superiority, single-blind, multicentre randomised controlled trial comparing online ERP for tics with online psychoeducation. The trial was conducted across two Child and Adolescent Mental Health Services in England. Participants were recruited from these two sites, across other clinics in England, or by self-referral. This study was a naturalistic follow-up of participants at 12- and 18-month postrandomisation. Participants were permitted to use alternative treatments recommended by their clinician. The key outcome was the Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS). A full economic evaluation was conducted. Registrations are ISRCTN (ISRCTN70758207); ClinicalTrials.gov (NCT03483493). RESULTS: Two hundred and twenty-four participants were enrolled: 112 to ERP and 112 to psychoeducation. The sample was predominately male (177; 79%) and of white ethnicity (195; 87%). The ERP intervention reduced baseline YGTSS-TTSS by 2.64 points (95% CI: -4.48 to -0.79) with an effect size of -0.36 (95% CI: -0.61 to -0.11) after 12 months and by 2.01 points (95% CI: -3.86 to -0.15) with an effect size of -0.27 (95% CI -0.52 to -0.02) after 18 months, compared with psychoeducation. Very few participants (<10%) started new tic treatment during follow-up. The cost difference in ERP compared with psychoeducation was £304.94 (-139.41 to 749.29). At 18 months, the cost per QALY gained was £16,708 for ERP compared with psychoeducation. CONCLUSIONS: Remotely delivered online ERP is a clinical and cost-effective intervention with durable benefits extending for up to 18 months. This represents an efficient public mental health approach to increase access to behavioural therapy and improve outcomes for tics.

Exploring Social Support in an Online Support Community for Tourette Syndrome and Tic Disorders: Analysis of Postings.

BACKGROUND: Online support communities have become an accessible way of gaining social, emotional, and informational support from peers and may be particularly useful for individuals with chronic conditions. To date, there have been few studies exploring the online support available for tic disorders, such as Tourette syndrome. An exploratory study looking at users' experiences with using online support communities for tic disorders suggested that members used such communities to share experiences, information, and strategies for tic management. OBJECTIVE: To build on these preliminary findings, this study examined the provision of social support in an online community for Tourette syndrome. METHODS: Data were collected from one publicly available online support community for Tourette syndrome and tics, from its inception to December 2019, by randomly selecting 10% of posts and their corresponding comments from each year for analysis. This resulted in 510 unique posts and 3802 comments posted from 1270 unique usernames. The data were analyzed using inductive thematic analysis. RESULTS: The findings of this study suggest that users utilized the online community as a multifaceted virtual place where they could share and ask for information about tics, unload and share their feelings arising from living with Tourette syndrome, find people facing similar situations and experiences, and freely share the realities of living with Tourette syndrome. CONCLUSIONS: The results complement the findings from a preliminary study and suggest that online support communities have a potentially valuable role as a mechanism for sharing and gaining information on illness experiences from similar peers experiencing tics and can promote self-management of tics. Limitations and recommendations for future research are discussed.

Therapist-Supported Internet-Delivered Exposure and Response Prevention for Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial.

Importance: The availability of behavior therapy for individuals with Tourette syndrome (TS) and chronic tic disorder (CTD) is limited. Objective: To determine the efficacy and cost-effectiveness of internet-delivered exposure and response prevention (ERP) for children and adolescents with TS or CTD. Design, Setting, and Participants: This single-masked, parallel group, superiority randomized clinical trial with nationwide recruitment was conducted at a research clinic in Stockholm, Sweden. Out of 615 individuals assessed for eligibility, 221 participants meeting diagnostic criteria for TS or CTD and aged 9 to 17 years were included in the study. Enrollment began in April 2019 and ended in April 2021. Data were analyzed between October 2021 and March 2022. Interventions: Participants were randomized to 10 weeks of therapist-supported internet-delivered ERP for tics (111 participants) or to therapist-supported internet-delivered education for tics (comparator group, 110 participants). Main Outcomes and Measures: The primary outcome was change in tic severity from baseline to the 3-month follow-up as measured by the Total Tic Severity Score of the Yale Global Tic Severity Scale (YGTSS-TTSS). YGTSS-TTSS assessors were masked to treatment allocation. Treatment response was operationalized as a score of 1 ("Very much improved") or 2 ("Much improved") on the Clinical Global Impression-Improvement scale. Results: Data loss was minimal, with 216 of 221 participants (97.7%) providing primary outcome data. Among randomized participants (152 [68.8%] boys; mean [SD] age, 12.1 [2.3] years), tic severity improved significantly, with a mean reduction of 6.08 points on the YGTSS-TTSS in the ERP group (mean [SD] at baseline, 22.25 [5.60]; at 3-month follow-up, 16.17 [6.82]) and 5.29 in the comparator (mean [SD] at baseline, 23.01 [5.92]; at 3-month follow-up, 17.72 [7.11]). Intention-to-treat analyses showed that the 2 groups improved similarly over time (interaction effect, -0.53; 95% CI, -1.28 to 0.22; P = .17). Significantly more participants were classified as treatment responders in the ERP group (51 of 108 [47.2%]) than in the comparator group (31 of 108 [28.7%]) at the 3-month follow-up (odds ratio, 2.22; 95% CI, 1.27 to 3.90). ERP resulted in more treatment responders at little additional cost compared with structured education. The incremental cost per quality-adjusted life-year gained was below the Swedish willingness-to-pay threshold, at which ERP had a 66% to 76% probability of being cost-effective. Conclusions and Relevance: Both interventions were associated with clinically meaningful improvements in tic severity, but ERP led to higher response rates at little additional cost. Trial Registration: ClinicalTrials.gov identifier: NCT03916055.

Self-help Digital Interventions Targeted at Improving Psychological Well-being in Young People With Perceived or Clinically Diagnosed Reduced Well-being: Systematic Review.

BACKGROUND: Levels of well-being are declining, whereas rates of mental health problems remain high in young people. The World Health Organization defines mental health as not merely the absence of mental disorder but also includes social and psychological well-being as integral to positive mental health, highlighting that mental health is applicable to young people with mental health conditions and those without a diagnosis of a mental health condition. Reduced mental well-being have been identified in studies of young people with clinical populations, as well as in populations consisting of nonclinical young people. Self-help digital interventions can be delivered at mass at a low cost and without the need for trained input, thereby facilitating access to support for well-being. Self-help interventions are effective in young people with mental health conditions, but systematic reviews of such studies have been limited to randomized controlled trials, have not included reduced well-being as an inclusion criterion, and do not consider engagement factors such as retention. OBJECTIVE: The objective of this study was to systematically review all controlled studies of digitally delivered, self-administered interventions for young people aged 9 to 25 years, with perceived or clinically diagnosed reduced psychological well-being. Participant retention and effectiveness of the interventions were also explored. METHODS: A systematic search of the PsycInfo, EMBASE, Cochrane, Scopus, and MEDLINE databases from inception to 2021, reference searches of relevant papers, and gray literature was carried out for digitally controlled studies conducted with young people with perceived or clinically diagnosed reduced well-being, aimed at improving psychological well-being. Data were extracted to identify the effectiveness and retention rates of the interventions and the quality of the studies. RESULTS: Overall, 1.04% (12/1153) of studies met the inclusion criteria: 83% (10/12) of studies were randomized controlled trials and 17% (2/12) were controlled pre-post studies. Most (6/12, 50%) studies aimed to improve symptoms of depression; 3 interventions aimed at both anxiety and depressive symptoms and 2 studies aimed at improving social functioning difficulties. Owing to the high risk of bias across interventions and lack of similar outcome measures, a meta-analysis was not conducted. Retention rates across studies were regarded as good, with moderate to high retention. Overall, the findings indicated that predominantly self-administered self-help interventions improved well-being in the areas targeted by the intervention and identified additional areas of well-being that were positively affected by interventions. Few interventions supported psychological well-being that was different from those used by young people with a clinical diagnosis of mental illness or young people from neurodiverse backgrounds. CONCLUSIONS: The findings, along with the advantages of self-help interventions, highlight the need for upscaling self-help interventions to better support vulnerable populations of young people who experience poor psychological well-being. TRIAL REGISTRATION: PROSPERO CRD42019129321; https://tinyurl.com/4fb2t4fz.

"I'm in pain and I want help": An online survey investigating the experiences of tic-related pain and use of pain management techniques in people with tics and tic disorders.

Objectives: Tic disorders (TDs) are complex neurological conditions characterized by involuntary, persistent vocalizations and motor movements called tics. Tics involve brief muscle movements and can impair many aspects of daily functioning and quality of life in patients - and their physical nature can cause pain. Understanding individuals' experiences of tic-related pain and pain management could help explore this under-researched area and identify additional support needs for this population. The aim of this study was to investigate experiences of pain and use of pain management techniques in people with tic disorders. Methods: An online survey consisting of multiple choice and open-ended questions exploring experiences of tic-related pain, help-seeking behavior for tic-related pain, and use of pain relief techniques for tic-related pain, was circulated online via international Tourette syndrome patient associations, and one online support group for Tourette syndrome. The online survey was open to adults (≥16 years) with self-reported tics. Open-ended questions were analyzed using thematic analysis. Results: One hundred eighty-one participants (16-71 years; 58.0% female) from 18 countries completed the online survey. Several aspects of tics were associated with pain, including the physical effort of motor tics (n = 177, 97.8%), repetitive tics (n = 141, 77.9%) and the consequences of tics (n = 131, 72.4%). Nearly two-thirds (n = 118, 64.6%) had sought professional help for tic-related pain. Distraction techniques (n = 126, 69.6%), taking pain relief medication (n = 125, 69.1%) and altering tics (n = 111, 61.3%) were the most commonly-reported methods used to relieve and cope with tic-related pain. Thematic analysis found an interrelated complex relationship between participants' tics, pain, and pain management techniques, reflected in four themes: the "tic-pain" cycle, the impact of pain, the importance of support, and the perceived successfulness of pain management techniques. Conclusions: Tic-related pain was reported to have a significant physical and psychological impact which impacted aspects of daily living in people with tic disorders. The findings add to limited research suggesting tic-related pain is a dominant issue for individuals with tic disorders, potentially impacting upon their quality of life. Increased understanding of tic-related pain and its influence may be helpful in the long-term management of tic disorders, both in terms of clinical management and patients' self-management.

Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial.

BACKGROUND: Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists and long travel distances to specialist clinics. Internet-delivered BT has the potential of overcoming these barriers through remote delivery of treatment with minimal therapist support. In the current protocol, we outline the design and methods of a randomised controlled trial (RCT) evaluating an internet-delivered BT programme referred to as BIP TIC. The trial's primary objective is to determine the clinical efficacy of BIP TIC for reducing tic severity in young people with TS/CTD, compared with an active control intervention. Secondary objectives are to investigate the 12-month durability of the treatment effects and to perform a health economic evaluation of the intervention. METHODS: In this single-blind superiority RCT, 220 participants (9-17 years) with TS/CTD throughout Sweden will be randomised to 10-12 weeks of either therapist-supported internet-delivered BT based on exposure with response prevention (BIP TIC) or therapist-supported internet-delivered education. Data will be collected at baseline, 3 and 5 weeks into the treatment, at post-treatment, and 3, 6, and 12 months post-treatment. The primary endpoint is the 3-month follow-up. The primary outcome is tic severity as measured by the Yale Global Tic Severity Scale - Total Tic Severity Score. Treatment response is operationalised as scores of "Very much improved" or "Much improved" on the Clinical Global Impression - Improvement scale, administered at the primary endpoint. Outcome assessors will be blind to treatment condition at all assessment points. A health economic evaluation of BIP TIC will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up). There are no planned interim analyses. DISCUSSION: Participant recruitment started on 26 April 2019 and finished on 9 April 2021. The total number of included participants was 221. The final participant is expected to reach the primary endpoint in September 2021 and the 12-month follow-up in June 2022. Data analysis for the primary objective will commence after the last participant reaches the primary endpoint. TRIAL REGISTRATION: ClinicalTrials.gov NCT03916055 . Registered on 16 April 2019.

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

BACKGROUND: Exposure and Response Prevention (ERP) is a form of behavioural therapy for tics; however, its effectiveness remains uncertain. We aimed to evaluate the effectiveness of internet-delivered, therapist-supported, and parent-assisted ERP for treatment of tics in children and young people with Tourette syndrome or chronic tic disorder. METHODS: This multicentre, parallel group, single-blind, randomised controlled trial was conducted across two study sites in England. Participants were recruited via 16 patient identification centres, two study sites in England (Nottingham and London), or online self-referral. Eligible participants were aged 9-17 years, had Tourette syndrome or chronic tic disorder, had not received behavioural therapy for tics in the past 12 months or were about to start, and had a Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) of more than 15 or more than 10 if they had only motor or vocal tics. Patients were excluded if they had started or stopped medication for tics within the past 2 months; had current alcohol or substance dependence, psychosis, suicidality, anorexia nervosa, or suspected moderate to severe intellectual disability; or presented an immediate risk to self or others; or the parent or carer was unable to speak, read, or write in English. Eligible patients were randomly assigned (1:1) by masked outcome assessors to receive 10 weeks of online, remotely delivered, therapist-supported ERP or psychoeducation (active control). Outcome assessors, statisticians, health economists, the trial manager, and the chief investigator were masked to group allocation. Patients were not directly informed of their allocation, but this could be established from the content once treatment commenced and the patients were not, therefore, considered masked to treatment. The primary outcome was YGTSS-TTSS 3 months after randomisation, and analysis was done in all randomised patients for whom data were available for each timepoint and outcome. Safety analysis was by intention to treat. Longer term follow-up is ongoing. This trial is registered with ISRCTN (ISRCTN70758207) and ClinicalTrials.gov (NCT03483493). FINDINGS: Between May 8, 2018, and Sept 30, 2019, we assessed 445 candidates for inclusion in the study. 221 potential participants were excluded (90 did not meet inclusion criteria, 84 declined to participate, and 47 unable to contact family). 224 participants were enrolled and randomly assigned to ERP (n=112) or psychoeducation (n=112). The enrolled patients were mostly male (n=177; 79%) and of White ethnicity (n=195; 87%). 11 patients were lost to follow-up 3 months after randomisation in the ERP group, compared with 12 patients in the psychoeducation group. Mean YGTSS-TTSS at 3 months after randomisation was 23·9 (SD 8·2) in the ERP group and 26·8 (7·3) in the psychoeducation group. The mean total decrease in YGTSS-TTSS at 3 months was 4·5 (16%, SD 1·1) in the ERP group versus 1·6 (6%, 1·0) in the psychoeducation group. The estimated mean difference in YGTSS-TTSS change between the groups adjusted for baseline and site was -2·29 points (95% CI -3·86 to -0·71) in favour of ERP, with an effect size of -0·31 (95% CI -0·52 to -0·10). Two serious adverse events occurred (one collapse and one tic attack), both in the psychoeducation group, neither of which were related to study treatment. INTERPRETATION: ERP is an effective behavioural therapy for tics. Remotely delivered, online 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. FUNDING: National Institute for Health Research and Health and Technology Assessment.

Fidelity of Delivery and Contextual Factors Influencing Children's Level of Engagement: Process Evaluation of the Online Remote Behavioral Intervention for Tics Trial.

BACKGROUND: The Online Remote Behavioral Intervention for Tics (ORBIT) study was a multicenter randomized controlled trial of a complex intervention that consisted of a web-based behavioral intervention for children and young people with tic disorders. In the first part of a two-stage process evaluation, we conducted a mixed methods study exploring the reach, dose, and fidelity of the intervention and contextual factors influencing engagement. OBJECTIVE: This study aims to explore the fidelity of delivery and contextual factors underpinning the ORBIT trial. METHODS: Baseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (N=112). The experiences of being in the intervention were explored through semistructured interviews with children (n=20) and parent participants (n=20), therapists (n=4), and referring clinicians (n=6). A principal component analysis was used to create a comprehensive, composite measure of children and young people's engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices, including chapters accessed, number of pages visited, and number of log-ins. The engagement factor score was used as the dependent variable in a multiple linear regression analysis with various contextual variables as independent variables to assess if there were any significant predictors of engagement. RESULTS: The intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. The engagement was high, with child participants completing an average of 7.5 of 10 (SD 2.7) chapters, and 88.4% (99/112) of participants completed the minimum of the first four chapters-the predefined threshold effective dose. Compared with the total population of children with tic disorders, participants in the sample tended to have more educated parents and lived in more economically advantaged areas; however, socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site versus the Nottingham site (P=.01), self-referred versus clinic referred (P=.04), higher parental engagement as evidenced by the number of parental chapters completed (n=111; ρ=0.73; P<.001), and more therapist time for parents (n=111; ρ=0.46; P<.001). A multiple linear regression indicated that parents' chapter completion (ß=.69; t110=10.18; P<.001) and therapist time for parents (ß=.19; t110=2.95; P=.004) were the only significant independent predictors of child engagement factor scores. CONCLUSIONS: Overall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parents were strong predictors of intervention implementation, which has important implications for designing and implementing digital therapeutic interventions in child and adolescent mental health services. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3974-3.

Commentary: Let's get digital: a commentary on Halldorsson et al.'s call for more rigorous development and evaluation of immersive digital interventions for children and young people's mental health.

In the JCPP Annual Research Review for 2021, Halldorsson and colleagues (2021) present a systematic review of applied games and virtual reality interventions for treating mental health problems in children and young people, looking at the effectiveness of interventions upon mental health outcomes but also on the experience of using such interventions. In this commentary, we highlight a number of considerations in understanding what research has been achieved so far, and ideas for what needs to be looked at next in further advancing this field.

"Drunk People Are on a Different Level": A Qualitative Study of Reflections From Students About Transitioning and Adapting to United Kingdom University as a Person Who Drinks Little or No Alcohol.

BACKGROUND: Though sobriety in young people is on the rise, students who drink little or no alcohol may experience social exclusion at University, impacting well-being. We aim to understand the social experiences of United Kingdom (UK) undergraduate students who drink little or no alcohol. METHODS: A mixed-methods study using semi-structured, one-to-one interviews and the 24-Item Social Provisions Scale and Flourishing Scale with 15 undergraduate students who drink little or no alcohol. Descriptive statistics are presented for quantitative data and thematic analysis for qualitative. RESULTS: Eight main themes and four subthemes were generated from thematic analysis summarised in two sections 'views of drinkers from non-drinkers' and 'how peer pressure feels and how people deal with it.' The initial transition to University represented a challenge, where participants struggled to find their 'true' friends. However, students generally had high levels of social provision, well-being and enjoyed close friendships with fewer casual acquaintances. All students experienced some kind of peer pressure (of a varying extremity) and developed coping strategies when in social situations involving alcohol. Fear of missing out on the 'typical' University experience heightened self-imposed expectations to drink. Despite participants acknowledging their counter-normative behaviour, some felt they were subject to stigmatisation by drinkers, doubting their non-drinker status, causing feelings of exclusion or being 'boring.' Their desire to 'be like everyone else' exposed some insight into the negative stereotypes of sobriety, including frustration behind alcohol's status elevation. CONCLUSION: Students adopt strategies to minimise peer pressure and to fit in. Future research should interrogate drinkers' perceptions of their sober peers to deepen understanding, better break down 'us and them,' and mitigate future expectations within the University drinking culture.

Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people.

BACKGROUND: Despite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT). METHOD: We extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online. RESULTS: Data were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials. CONCLUSION: An approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery. TRIAL REGISTRATION: The ORBIT trial is registered with ISRTCN ( ISRCTN70758207 ) Registered on March 20, 2018. and ClinicalTrials.gov ( NCT03483493 ). Registered on March 30, 2018.

Using Online Support Communities for Tourette Syndrome and Tic Disorders: Online Survey of Users' Experiences.

BACKGROUND: People living with a tic disorder (TD)-such as Tourette syndrome (TS)-experience many negative psychological and social challenges arising from chronic tics, such as stigmatization from peers and poorer quality of life, and these can impact upon their families too. It can be difficult for this population to access face-to-face support for tics, and so online support communities offer one avenue for support from peers facing similar experiences. However, little is known about how online support communities may be used by people with TS and other TDs, and by others (eg, parents, caregivers) supporting a person with TS/TD. OBJECTIVE: This study aimed to explore users' experiences of participation in online support communities for TS and TDs. METHODS: In total, 90 respondents (aged 13-62 years; 62% [56/90] female) from 13 countries completed an online survey exploring their experiences of using online support communities for TS and TDs. Respondents were people living with TS/TD themselves (n=68) or supportive others of someone with TS/TD (eg, parent, sibling, spouse; n=14), or both (n=8). The online survey contained open-ended questions eliciting their self-reported motivations for using online communities, their benefits and drawbacks of participation, and whether online support communities affected offline management of tics. Responses were analyzed using thematic analysis. RESULTS: Seven overarching themes captured experiences of using online support communities for TS/TDs. The overwhelming reason for their use was to find accessible support due to a lack of offline face-to-face support. Online support communities were valued sources of informational and emotional support, and also had a positive impact upon helping users' psychological well-being. Online communities helped provide a space where people with TS/TDs could feel accepted and reduce the social isolation they felt offline. The suggestible nature of tics and being reminded of the challenging nature of TDs were main disadvantages arising from using online support communities, alongside conflict arising within online communities. CONCLUSIONS: The findings suggest that online support communities appear to offer valuable informational and emotional support to those living with TS/TD and their families too, especially given the lack of locally available support. This facilitates a sense of community online, which can help users in overcoming long-standing social isolation and aid self-reported improvements in psychosocial well-being. Users reported some drawbacks in engaging with online support communities, such as conflict between different types of users and triggering content, which negatively affected experiences of community participation.

Preventive digital mental health interventions for children and young people: a review of the design and reporting of research.

Digital health interventions (DHIs) have frequently been highlighted as one way to respond to increasing levels of mental health problems in children and young people. Whilst many are developed to address existing mental health problems, there is also potential for DHIs to address prevention and early intervention. However, there are currently limitations in the design and reporting of the development, evaluation and implementation of preventive DHIs that can limit their adoption into real-world practice. This scoping review aimed to examine existing evidence-based DHI interventions and review how well the research literature described factors that researchers need to include in their study designs and reports to support real-world implementation. A search was conducted for relevant publications published from 2013 onwards. Twenty-one different interventions were identified from 30 publications, which took a universal (n = 12), selective (n = 3) and indicative (n = 15) approach to preventing poor mental health. Most interventions targeted adolescents, with only two studies including children aged ≤10 years. There was limited reporting of user co-design involvement in intervention development. Barriers and facilitators to implementation varied across the delivery settings, and only a minority reported financial costs involved in delivering the intervention. This review found that while there are continued attempts to design and evaluate DHIs for children and young people, there are several points of concern. More research is needed with younger children and those from poorer and underserved backgrounds. Co-design processes with children and young people should be recognised and reported as a necessary component within DHI research as they are an important factor in the design and development of interventions, and underpin successful adoption and implementation. Reporting the type and level of human support provided as part of the intervention is also important in enabling the sustained use and implementation of DHIs.

Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice.

In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.