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Fear of giving birth alone: Experiences of psychological distress, symptoms of anxiety and depression, and coping- strategies of childbearing women during COVID-19.
BACKGROUND: Psychological distress during pregnancy is a well-documented risk factor for adverse maternal outcomes. Distress related to the COVID-19 pandemic may further increase the vulnerability of pregnant women to negative mental health outcomes. AIM: To explore the mental health experiences of pregnant women, focusing on mental health outcomes, challenges related to the pandemic, coping strategies, and factors buffering mental health factors during the restricted COVID-19 lockdown period. METHODS: A mixed-methods survey study was conducted, examining symptoms of anxiety, depression, and burnout among 21 pregnant women. Qualitative data were gathered through open-ended questions about participants' experiences of challenges, coping strategies and buffering factors amid the pandemic. Symptoms of anxiety, depression and burnout were calculated, and qualitative data was thematically analyzed. RESULTS: Approximately one-third (24 %) of the respondents reported clinically significant levels of depression, 19 % reported clinically significant levels of anxiety, and 43 % reported experiencing burnout. All participants reported distress and emotional burden, including fear, worry, stress and anxiety related to the pandemic. Specific concerns such as fear of giving birth alone, fear of the consequences due to lockdown restrictions, insufficient information, disruption of prenatal healthcare services, and fear of miscarriage were prevalent among the participants. Social support, financial stability, stable relationships, adherence to daily routines, reduced stress and social demands, a calmer daily life, physical activity, and less work-related stress including working from home, emerges as buffering factors that aided women in coping with pandemic-related distress. CONCLUSION: Healthcare providers should prioritize stability, predictability, and minimizing disruptions to prenatal care. Broad-based screening is crucial to identify women at risk of depression, anxiety, and burnout. Recommendations for clinical pathways aimed at pregnant women are discussed.
Distinguishing absence of awareness from awareness of absence
Contrasting brain states when subjects are aware compared to unaware of a presented stimulus has allowed researchers to isolate candidate neural correlates of consciousness. Here we propose that an important next step in this research program is to investigate, perhaps paradoxically, brain states that covary with reports of absences of awareness. Specifically, we propose that in order to distinguish content-specific and content-invariant neural correlates of consciousness, a distinction needs to be made between the neural correlates of awareness of stimulus absence, and the neural correlates of absence of awareness (of either stimulus presence or absence). We ground this distinction in higher-order computational models of consciousness, where the state of higher-order nodes is invariant to the specific contents of awareness. To map the different levels of these models to neurophysiological correlates, we suggest two empirical approaches - inverted designs and two-dimensional awareness reports - in which reports about awareness and stimulus presence can be dissociated.
The impact of trauma and how to intervene: a narrative review of psychotraumatology over the past 15 years.
To mark 15 years of the European Journal of Psychotraumatology, editors reviewed the past 15-year years of research on trauma exposure and its consequences, as well as developments in (early) psychological, pharmacological and complementary interventions. In all sections of this paper, we provide perspectives on sex/gender aspects, life course trends, and cross-cultural/global and systemic societal contexts. Globally, the majority of people experience stressful events that may be characterized as traumatic. However, definitions of what is traumatic are not necessarily straightforward or universal. Traumatic events may have a wide range of transdiagnostic mental and physical health consequences, not limited to posttraumatic stress disorder (PTSD). Research on genetic, molecular, and neurobiological influences show promise for further understanding underlying risk and resilience for trauma-related consequences. Symptom presentation, prevalence, and course, in response to traumatic experiences, differ depending on individuals' age and developmental phase, sex/gender, sociocultural and environmental contexts, and systemic socio-political forces. Early interventions have the potential to prevent acute posttraumatic stress reactions from escalating to a PTSD diagnosis whether delivered in the golden hours or weeks after trauma. However, research on prevention is still scarce compared to treatment research where several evidence-based psychological, pharmacological and complementary/ integrative interventions exist, and novel forms of delivery have become available. Here, we focus on how best to address the range of negative health outcomes following trauma, how to serve individuals across the age spectrum, including the very young and old, and include considerations of sex/gender, ethnicity, and culture in diverse contexts, beyond Western, Educated, Industrialized, Rich, and Democratic (WEIRD) countries. We conclude with providing directions for future research aimed at improving the well-being of all people impacted by trauma around the world. The 15 years EJPT webinar provides a 90-minute summary of this paper and can be downloaded here [http://bit.ly/4jdtx6k].
Posttraumatic Stress Disorder
Posttraumatic stress disorder (PTSD) is a common and disabling condition that can arise following severely threatening events. It is characterized by the re-experiencing of trauma memories, such as through flashbacks, nightmares or emotional reactions, avoidance of memories and reminders of the trauma, negative trauma-related cognitions and affect, and hyperarousal symptoms. This chapter reviews the epidemiology and diagnosis of PTSD, as well as current theoretical models and evidence-based treatments used to address the disorder. The chapter uses cognitive therapy for PTSD as an example to describe how to conduct effective trauma-focused cognitive behavioral therapy. The potential for resilience interventions and future developments in the field are also discussed.
More and Less Fear in Serotonin Transporter Knockout Mice.
Recent theories suggest that reduced serotonin transporter (5-HTT) function, which increases serotonin (5-HT) levels at the synapse, enhances neural plasticity and affects sensitivity to environmental cues. This may promote learning about emotionally relevant events. However, the boundaries that define such emotional learning remain to be established. This was investigated using 5-HTT knockout (5-HTTKO) mice which provide a model of long-term elevated 5-HT transmission and are associated with increased anxiety. Compared to wild-type controls, 5-HTTKO mice were faster to discriminate between an auditory cue that predicted footshock (CS+) and a cue predicting no footshock (CS-). Notably, this enhanced discrimination performance was driven not by faster learning that the CS+ predicted footshock, but rather by faster learning that the CS- cue signals the absence of footshock and thus provides temporary relief from fear/anxiety. Similarly, 5-HTTKO mice were also faster to reduce their fear of the CS+ cue during subsequent extinction. These findings are consistent with facilitated inhibitory learning that predicts the absence of potential threats in 5-HTTKO mice. However, 5-HTTKO mice also exhibited increased generalisation of fear learning about ambiguous aversive cues in a novel context, different from the training context. Thus, 5-HTTKO mice can exhibit both more and less fear compared to wild-type controls. Taken together, our results support the idea that loss of 5-HTT function, and corresponding increases in synaptic 5-HT availability, may facilitate learning by priming of aversive memories. This both facilitates inhibitory learning for fear memories but also enhances generalisation of fear.
Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i).
BACKGROUND: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. METHODS AND DESIGN: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.
Target mechanisms of mindfulness-based programmes and practices: a scoping review.
QUESTION: Mindfulness-based programmes (MBPs) and practices have demonstrated effects in mental health and well-being, yet questions regarding the target mechanisms that drive change across the population remain unresolved. STUDY SELECTION AND ANALYSIS: Five databases were searched for randomised controlled trials that evaluate the indirect effects (IEs) of an MBP or mindfulness practice in relation to mental health and well-being outcomes through psychological mechanisms. FINDINGS: 27 eligible studies were identified, with only four exploring mechanisms in the context of specific mindfulness practices. Significant IEs were reported for mindfulness skills, decentering and attitudes of mindfulness (eg, self-compassion) across different outcomes, population samples, mental health strategies and active comparators. Evidence gap maps and requirements for testing and reporting IEs are provided to help guide future work. CONCLUSIONS: Mindfulness skills, decentering and attitudes of mindfulness may be key intervention targets for addressing the mental health of whole populations. However, future work needs to address significant knowledge gaps regarding the evidence for alternative mechanisms (eg, attention and awareness) in relation to unique outcomes (eg, well-being), mental health strategies (ie, promotion) and active comparators. High-quality trials, with powered multivariate mediation analyses that meet key requirements, will be needed to advance this area of work. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/NY2AH.
What Next After MBSR/MBCT? An Open Trial of an 8-Week Follow-on Program Exploring Mindfulness of Feeling Tone (vedanā).
OBJECTIVES: The effectiveness of mindfulness-based programs (MBPs) has been established in many randomized controlled trials. However, effect sizes are often modest, and there remains ample scope to improve their effectiveness. One approach to this challenge is to offer a "follow-on" course to people who have completed an MBP and are interested in further skill development. We developed and tested a new 8-week course for this purpose based on awareness of feeling tone (vedanā), an understudied aspect of mindfulness in many current MBPs, incorporating new developments in neuroscience and trauma sensitivity. We examined its effectiveness and the frequency and severity of unpleasant experience and harm. METHODS: In an open trial, 83 participants, 78 of whom had previously taken part in an MBP (majority MBSR or MBCT), completed the program in nine groups. Participants completed questionnaires before and after and gave qualitative written feedback at completion. RESULTS: Participants reported significantly reduced depression (d = 0.56), stress (d = 0.36), and anxiety (d = 0.53) and increased well-being (d = 0.54) and mindfulness (d = 0.65) with 38% meeting criteria for reliable change on anxiety and depression. As expected, about three-quarters of participants reported some unpleasant experiences associated with mindfulness practice during the course, but none reported harm. Five participants showed "reliable deterioration" (an increase) in either depression or anxiety, but four of these five also gave anonymous qualitative feedback describing benefits of the course. CONCLUSIONS: Findings support the added value of a follow-on course based on the exploration of feeling tone for participants who have a range of previous mindfulness experience. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12671-022-01929-0.
Universal Mindfulness Training in Schools for Adolescents: a Scoping Review and Conceptual Model of Moderators, Mediators, and Implementation Factors.
There is evidence that universal school-based mindfulness training (SBMT) can have positive effects for young people. However, it is unknown who benefits most from such training, how training exerts effects, and how implementation impacts effects. This study aimed to provide an overview of the evidence on the mediators, moderators, and implementation factors of SBMT, and propose a conceptual model that can be used both to summarize the evidence and provide a framework for future research. A scoping review was performed, and six databases and grey literature were searched. Inclusion and exclusion criteria were applied to select relevant material. Quantitative and qualitative information was extracted from eligible articles and reported in accordance with PRISMA-ScR guidelines. The search produced 5479 articles, of which 31 were eligible and included in the review. Eleven studies assessed moderators of SBMT on pupil outcomes, with mixed findings for all variables tested. Five studies examined the mediating effect of specific variables on pupil outcomes, with evidence that increases in mindfulness skills and decreases in cognitive reactivity and self-criticism post-intervention are related to better pupil outcomes at follow-up. Twenty-five studies assessed implementation factors. We discuss key methodological shortcomings of included studies and integrate our findings with existing implementation frameworks to propose a conceptual model. Widespread interest in universal SBMT has led to increased research over recent years, exploring who SBMT works for and how it might work, but the current evidence is limited. We make recommendations for future research and provide a conceptual model to guide theory-led developments.
Do mindfulness-based programmes improve the cognitive skills, behaviour and mental health of children and adolescents? An updated meta-analysis of randomised controlled trials.
QUESTION: Mindfulness-based programmes (MBPs) are an increasingly popular approach to improving mental health in young people. Our previous meta-analysis suggested that MBPs show promising effectiveness, but highlighted a lack of high-quality, adequately powered randomised controlled trials (RCTs). This updated meta-analysis assesses the-state-of the-art of MBPs for young people in light of new studies. It explores MBP's effectiveness in active vs passive controls; selective versus universal interventions; and studies that included follow-up. STUDY SELECTION AND ANALYSIS: We searched for published and unpublished RCTs of MBPs with young people (<19 years) in PubMed Central, PsycINFO, Web of Science, EMBASE, ICTRP, ClinicalTrials.gov, EThOS, EBSCO and Google Scholar. Random-effects meta-analyses were conducted, and standardised mean differences (Cohen's d) were calculated. FINDINGS: Sixty-six RCTs, involving 20 138 participants (9552 receiving an MBP and 10 586 controls), were identified. Compared with passive controls, MBPs were effective in improving anxiety/stress, attention, executive functioning, and negative and social behaviour (d from 0.12 to 0.35). Compared against active controls, MBPs were more effective in reducing anxiety/stress and improving mindfulness (d=0.11 and 0.24, respectively). In studies with a follow-up, there were no significant positive effects of MBPs. No consistent pattern favoured MBPs as a universal versus selective intervention. CONCLUSIONS: The enthusiasm for MBPs in youth has arguably run ahead of the evidence. While MBPs show promising results for some outcomes, in general, the evidence is of low quality and inconclusive. We discuss a conceptual model and the theory-driven innovation required to realise the potential of MBPs in supporting youth mental health.
Adolescent girls' explanations of high rates of low mood and anxiety in their population: a co-produced qualitative study.
BACKGROUND: From early adolescence, girls face greater risk of experiencing low mood and anxiety relative to boys, with recent evidence that this may be worsening. There is a paucity of mental health research that meaningfully progresses understanding of these gender disparities, including that engages adolescent girls' own perspectives, limiting our ability to direct further research and enhance intervention approaches. AIMS: We examined low mood and anxiety from the perspective of adolescent girls, asking: What do adolescent girls perceive to be causing their population's high rates of low mood and anxiety? METHODS: We adopted a co-produced qualitative design, guided by ecological systems theory, conducting focus groups in 2022 with 32 adolescent girls aged 16 to 18 years in England. Data were analysed using reflexive thematic analysis. ANALYSIS: Participants framed low mood and anxiety among adolescent girls as "normal", and discussed potential explanations including persistent reiteration and expectation of gendered norms, intense educational pressures in ways that can be gendered, difficulties within peer relationships, and comparison and insecurity in social media contexts. Throughout, participants highlighted how complex these issues are, including nuances around individual differences, sociodemographic contexts, and societal contexts. CONCLUSIONS: The study offers a critically important contribution to evidence on gendered inequalities in low mood and anxiety, drawing attention to the interwoven and complex nature of girls' lives and illuminating various aspects that would benefit from greater research. The insights gained through exploration with girls themselves hold policy and practical relevance to enhance systems to meet girls' needs.
Comparing apples and oranges in youth depression treatments? A quantitative critique of the evidence base and guidelines.
OBJECTIVES: Should a young person receive psychotherapy or medication for their depression and on what evidence do we base this decision? In this paper, we test the factors across modalities that may influence comparability between medication and psychotherapy trials. METHODS: We included 92 randomised controlled trials (RCTs) of psychotherapy and medication for child and adolescent depression (mean age 4-18 years). Using meta-analyses, we compared (a) participant characteristics and (b) trial characteristics in medication and psychotherapy trials. Lastly, we examined whether psychotherapy controls are well-matched to active conditions. RESULTS: Participants in medication RCTs had higher depression severity and were more frequently male compared with psychotherapy RCTs. There was a dramatic difference in the within-subject improvement due to placebo (SMD=-1.9 (95% CI: -2.1 to -1.7)) vs. psychotherapy controls (SMD=-0.6 (95% CI: -0.9 to -0.3)). Within psychotherapy RCTs, control conditions were less intensive on average than active conditions. CONCLUSIONS: Medication and psychotherapy RCTs differ on fundamental participant and methodological characteristics, thereby raising questions about their comparability. Psychotherapy controls often involve little therapist contact and are easy-to-beat comparators. These findings cast doubt on the confidence with which psychotherapy is recommended for youth depression and highlight the pressing need to improve the evidence base.
Digitally augmented, parent-led CBT versus treatment as usual for child anxiety problems in child mental health services in England and Northern Ireland: a pragmatic, non-inferiority, clinical effectiveness and cost-effectiveness randomised controlled trial.
BACKGROUND: Anxiety problems are common in children, yet few affected children access evidence-based treatment. Digitally augmented psychological therapies bring potential to increase availability of effective help for children with mental health problems. This study aimed to establish whether therapist-supported, digitally augmented, parent-led cognitive behavioural therapy (CBT) could increase the efficiency of treatment without compromising clinical effectiveness and acceptability. METHODS: We conducted a pragmatic, unblinded, two-arm, multisite, randomised controlled non-inferiority trial to evaluate the clinical effectiveness and cost-effectiveness of therapist-supported, parent-led CBT using the Online Support and Intervention (OSI) for child anxiety platform compared with treatment as usual for child (aged 5-12 years) anxiety problems in 34 Child and Adolescent Mental Health Services in England and Northern Ireland. We examined acceptability of OSI plus therapist support via qualitative interviews. Participants were randomly assigned (1:1) to OSI plus therapist support or treatment as usual, minimised by child age, gender, service type, and baseline child anxiety interference. Outcomes were assessed at week 14 and week 26 after randomisation. The primary clinical outcome was parent-reported interference caused by child anxiety at week 26 assessment, using the Child Anxiety Impact Scale-parent report (CAIS-P). The primary measure of health economic effect was quality-adjusted life-years (QALYs). Outcome analyses were conducted blind in the intention-to-treat (ITT) population with a standardised non-inferiority margin of 0·33 for clinical analyses. The trial was registered with ISRCTN, 12890382. FINDINGS: Between Dec 5, 2020, and Aug 3, 2022, 706 families (706 children and their parents or carers) were referred to the study information. 444 families were enrolled. Parents reported 255 (58%) child participants' gender to be female, 184 (41%) male, three (<1%) other, and one (<1%) preferred not to report their child's gender. 400 (90%) children were White and the mean age was 9·20 years (SD 1·79). 85% of families for whom clinicians provided information in the treatment as usual group received CBT. OSI plus therapist support was non-inferior for parent-reported anxiety interference on the CAIS-P (SMD 0·01, 95% CI -0·15 to 0·17; p<0·0001) and all secondary outcomes. The mean difference in QALYs across trial arms approximated to zero, and OSI plus therapist support was associated with lower costs than treatment as usual. OSI plus therapist support was likely to be cost effective under certain scenarios, but uncertainty was high. OSI plus therapist support acceptability was good. No serious adverse events were reported. INTERPRETATION: Digitally augmented intervention brought promising savings without compromising outcomes and as such presents a valuable tool for increasing access to psychological therapies and meeting the demand for treatment of child anxiety problems. FUNDING: Department for Health and Social Care and United Kingdom Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, Oxford Health NIHR Biomedical Research Centre.
Effectiveness of universal school-based mindfulness training compared with normal school provision on teacher mental health and school climate: results of the MYRIAD cluster randomised controlled trial.
BACKGROUND: Education is broader than academic teaching. It includes teaching students social-emotional skills both directly and indirectly through a positive school climate. OBJECTIVE: To evaluate if a universal school-based mindfulness training (SBMT) enhances teacher mental health and school climate. METHODS: The My Resilience in Adolescence parallel group, cluster randomised controlled trial (registration: ISRCTN86619085; funding: Wellcome Trust (WT104908/Z/14/Z, WT107496/Z/15/Z)) recruited 85 schools (679 teachers) delivering social and emotional teaching across the UK. Schools (clusters) were randomised 1:1 to either continue this provision (teaching as usual (TAU)) or include universal SBMT. Data on teacher mental health and school climate were collected at prerandomisation, postpersonal mindfulness and SBMT teacher training, after delivering SBMT to students, and at 1-year follow-up. FINDING: Schools were recruited in academic years 2016/2017 and 2017/2018. Primary analysis (SBMT: 43 schools/362 teachers; TAU: 41 schools/310 teachers) showed that after delivering SBMT to students, SBMT versus TAU enhanced teachers' mental health (burnout) and school climate. Adjusted standardised mean differences (SBMT minus TAU) were: exhaustion (-0.22; 95% CI -0.38 to -0.05); personal accomplishment (-0.21; -0.41, -0.02); school leadership (0.24; 0.04, 0.44); and respectful climate (0.26; 0.06, 0.47). Effects on burnout were not significant at 1-year follow-up. Effects on school climate were maintained only for respectful climate. No SBMT-related serious adverse events were reported. CONCLUSIONS: SBMT supports short-term changes in teacher burnout and school climate. Further work is required to explore how best to sustain improvements. CLINICAL IMPLICATIONS: SBMT has limited effects on teachers' mental and school climate. Innovative approaches to support and preserve teachers' mental health and school climate are needed.
Effectiveness and cost-effectiveness of universal school-based mindfulness training compared with normal school provision in reducing risk of mental health problems and promoting well-being in adolescence: the MYRIAD cluster randomised controlled trial.
BACKGROUND: Systematic reviews suggest school-based mindfulness training (SBMT) shows promise in promoting student mental health. OBJECTIVE: The My Resilience in Adolescence (MYRIAD) Trial evaluated the effectiveness and cost-effectiveness of SBMT compared with teaching-as-usual (TAU). METHODS: MYRIAD was a parallel group, cluster-randomised controlled trial. Eighty-five eligible schools consented and were randomised 1:1 to TAU (43 schools, 4232 students) or SBMT (42 schools, 4144 students), stratified by school size, quality, type, deprivation and region. Schools and students (mean (SD); age range=12.2 (0.6); 11-14 years) were broadly UK population-representative. Forty-three schools (n=3678 pupils; 86.9%) delivering SBMT, and 41 schools (n=3572; 86.2%) delivering TAU, provided primary end-point data. SBMT comprised 10 lessons of psychoeducation and mindfulness practices. TAU comprised standard social-emotional teaching. Participant-level risk for depression, social-emotional-behavioural functioning and well-being at 1 year follow-up were the co-primary outcomes. Secondary and economic outcomes were included. FINDINGS: Analysis of 84 schools (n=8376 participants) found no evidence that SBMT was superior to TAU at 1 year. Standardised mean differences (intervention minus control) were: 0.005 (95% CI -0.05 to 0.06) for risk for depression; 0.02 (-0.02 to 0.07) for social-emotional-behavioural functioning; and 0.02 (-0.03 to 0.07) for well-being. SBMT had a high probability of cost-effectiveness (83%) at a willingness-to-pay threshold of £20 000 per quality-adjusted life year. No intervention-related adverse events were observed. CONCLUSIONS: Findings do not support the superiority of SBMT over TAU in promoting mental health in adolescence. CLINICAL IMPLICATIONS: There is need to ask what works, for whom and how, as well as considering key contextual and implementation factors. TRIAL REGISTRATION: Current controlled trials ISRCTN86619085. This research was funded by the Wellcome Trust (WT104908/Z/14/Z and WT107496/Z/15/Z).
A randomised controlled trial to compare clinical and cost-effectiveness of an online parent-led treatment for child anxiety problems with usual care in the context of COVID-19 delivered in Child and Adolescent Mental Health Services in the UK (Co-CAT): a study protocol for a randomised controlled trial.
BACKGROUND: In the context of COVID-19, NHS Child and Adolescent Mental Health Services (CAMHS) and other children's mental health services have faced major challenges in providing psychological treatments that (i) work when delivered remotely and (ii) can be delivered efficiently to manage increases in referrals as social distancing measures have been relaxed. Anxiety problems are a common reason for referral to CAMHS, children with pre-existing anxiety problems are particularly vulnerable in the context of COVID-19, and there were concerns about increases in childhood anxiety as schools reopened. The proposed research will evaluate the clinical and cost-effectiveness of a brief online parent-led cognitive behavioural treatment (CBT) delivered by the OSI (Online Support and Intervention for child anxiety) platform with remote support from a CAMHS therapist compared to 'COVID-19 treatment as usual' (C-TAU) in CAMHS and other children's mental health services throughout the COVID-19 pandemic. METHODS: We will conduct a two-arm, multi-site, randomised controlled non-inferiority trial to evaluate the clinical and cost-effectiveness of OSI with therapist support compared to CAMHS and other child mental health services 'COVID-19 treatment as usual' (C-TAU) during the COVID-19 outbreak and to explore parent and therapists' experiences. DISCUSSION: If non-inferiority is shown, the research will provide (1) a solution for efficient psychological treatment for child anxiety disorders while social distancing (for the COVID-19 context and future pandemics); (2) an efficient means of treatment delivery as 'normal service' resumes to enable CAMHS to cope with the anticipated increase in referrals; and (3) a demonstration of rapid, high-quality evaluation and application of online interventions within NHS CAMHS to drive forward much-needed further digital innovation and evaluation in CAMHS settings. The primary beneficiaries will be children with anxiety disorders and their families, NHS CAMHS teams, and commissioners who will access a potentially effective, cost-effective, and efficient treatment for child anxiety problems. TRIAL REGISTRATION: ISRCTN ISRCTN12890382 . Registered prospectively on 23 October 2020.