Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders : a single-centre, single-blind, randomised controlled trial

Background: Paediatric anxiety disorders are prevalent and associated with substantial disability and long-term adverse consequences. Only a minority of affected children have access to evidence-based treatment; internet-delivered cognitive behaviour therapy (ICBT) could help increase accessibility but needs further rigorous evaluation. The objective of this trial was to evaluate the clinical efficacy and cost-effectiveness of ICBT in the treatment of paediatric anxiety disorders. Methods: In this single-blind randomised controlled trial, children 8-12 years with a principal anxiety disorder diagnosis were randomly allocated (1:1) to ICBT or internet-delivered child-directed play (ICDP), an active comparator aimed to improve parent-child relationships and increase child self-esteem without directly targeting anxiety. The study was conducted at a single site within the Stockholm specialist child and adolescent mental health services (CAMHS). Primary endpoint was clinician-rated symptom severity (CSR) of the principal anxiety disorder at post-treatment. All participants were included in the primary analysis (intent-to-treat). Trial registration number: NCT02350257. Findings: Participants (N=131) were recruited between March 2015 and October 2016, mainly via advertisement and referrals from CAMHS, and allocated to ICBT (n=66) or ICDP (n=65). Analyses revealed greater reduction of symptom severity in favour of ICBT (mean difference 0·79, 95% CI 0·42 to 1·16, p=0·002; Cohen’s d=0·77, 95% CI 0·40 to 1·15) and at post-treatment, 48% (n=29) of participants randomised to ICBT no longer fulfilled their principal diagnosis, compared to 15% (n=9) in ICDP (odds ratio 5·41, 95% CI 2·26 to 12·90, p<0·0001). Numbers needed to treat were 3 (95% CI 2·85 to 3·15). Treatment gains were maintained at 3-month follow-up, at which point 70% (n=40) of participants randomised to ICBT no longer met the criteria for their principal anxiety disorder. ICBT resulted in an average societal cost saving of €493·05 (95% CI 477·17 to 508·92) per participant. No severe adverse events were reported. Interpretation: ICBT is a cost-effective treatment for paediatric anxiety disorders that should be considered for implementation in routine clinical care.The Swedish Research Council for Health, Working Life and WelfareStockholm County CouncilAccepte

Research Review: Recommendations for reporting on treatment trials for child and adolescent anxiety disorders - an international consensus statement

Background: Anxiety disorders in children and young people are common and bring significant personal and societal costs. Over the last two decades, there has been a substantial increase in research evaluating psychological and pharmacological treatments for anxiety disorders in children and young people and exciting and novel research has continued as the field strives to improve efficacy and effectiveness, and accessibility of interventions. This increase in research brings potential to draw together data across studies to compare treatment approaches and advance understanding of what works, how, and for whom. There are challenges to these efforts due largely to variation in studies' outcome measures and variation in the way study characteristics are reported, making it difficult to compare and/or combine studies, and this is likely to lead to faulty conclusions. Studies particularly vary in their reliance on child, parent, and/or assessor-based ratings across a range of outcomes, including remission of anxiety diagnosis, symptom reduction, and other domains of functioning (e.g., family relationships, peer relationships). Methods: To address these challenges, we convened a series of international activities that brought together the views of key stakeholders (i.e., researchers, mental health professionals, young people, parents/caregivers) to develop recommendations for outcome measurement to be used in treatment trials for anxiety disorders in children and young people. Results and conclusions: This article reports the results of these activities and offers recommendations for selection and reporting of outcome measures to (a) guide future research and (b) improve communication of what has been measured and reported. We offer these recommendations to promote international consistency in trial reporting and to enable the field to take full advantage of the great opportunities that come from data sharing going forward

Internet-delivered cognitive behaviour therapy for paediatric anxiety disorders in clinical settings : increasing access to evidence-based treatments

Background: Paediatric anxiety disorders are common, impairing and associated with a societal and economic burden. Even though there are efficacious treatments to treat these disorders, access to them are limited. Internet-delivered cognitive behaviour therapy (ICBT) has gained support for being an efficacious treatment for paediatric anxiety disorders and is suggested as one possible solution to increase access to evidence-based treatments. Aims and methods: The main aim of this thesis was to evaluate the BiP Anxiety programme, for children aged 8 to 12 years old with an anxiety disorder, in two clinical settings. First by con­ducting a randomised controlled trial within a specialised ICBT clinic part of the child and adolescent mental health services (CAMHS) in Stockholm. Secondly by conduct­ing a pilot feasibility trial at a CAMHS outpatient clinic in rural Sweden. Specific aims were to evaluate (1) the effects and cost-effectiveness ofICBT compared to an active placebo control, (2) the long term effect of ICBT within a stepped-care model where non-remitters of treatment were offered additional treatment, (3) predictors of treatment outcome, and ( 4) the feasibility and potential effectiveness ofICBT when disseminated in an outpatient clinic in rural Sweden. Results: ICBT was effective in reducing anxiety symptoms in a cost-effective manner when compared to a placebo condition controlling for non-specific therapeutic factors such as attention and weekly homework assignments. Treatment gains were maintained up to 12 months after the end of the treatment. Participants with a principal diagnosis of separation anxiety disorder, and those more engaged in behaviour change were more likely to be in remission at the three-months follow-up. Participants with more severe anxiety were less likely of being in remission. Additional face-to-face treatment for non-remitters ofICBT was efficacious for those receiving it. The majority of non-remitters however declined this offer down, mostly due to already receiving treatment for other mental health disorders ( e.g., depression) at their local CAMHS. Also, ICBT seemed to be feasible and potentially also effective when disseminated to an outpatient clinic in rural Sweden. Conclusion: ICBT is an effective treatment, at least for children with moderate anxiety disorders. ICBT could be suitable as a first-line treatment, but a greater understanding about to whom it should be offered and when the treatment should be stepped up is needed. ICBT should be implemented as part of a specialised clinic to ensure the necessary education, support and supervision. However, other models of implementation might be required in rural areas where the resources needed for a specialised clinic cannot be motivated

Intolerance of uncertainty-focused treatment for adolescents with excessive worry - A pilot feasibility study

Bouts of excessive worry are common across the lifespan, increasing in frequency and complexity during adolescence and adulthood, and are found in several psychiatric disorders, particularly the anxiety disorders. There are evidence-based treatments for adolescents with anxiety disorders but psychological treatments designed specifically to target excessive worrying in adolescents are rare. Intolerance of uncertainty (IU), a cognitive predisposition described as a fear of the unknown, is highly associated with worry among adolescents. This study investigated the feasibility, acceptability, and preliminary efficacy of IU-focused cognitive behavioral therapy (IU-CBT) for adolescents with excessive worry. Twelve participants (aged 13–17 years) with excessive worry, irrespective of psychiatric diagnosis, were provided weekly face-to-face sessions, primarily including therapist and self-guided exposure to situations involving uncertainty. Sessions were supplemented with an internet-delivered educational program for parents, designed to teach parents about worry, IU and helpful parental behaviors. The main outcome measure was the Penn-State Worry Questionnaire for Children (PSWQ-C). The treatment was well tolerated with no dropouts and families reporting being satisfied with the treatment. Participants were able to grasp the notion of IU and its relationship to worry and avoidance. Significant reductions were observed for self-reported worry, anxiety, depression, IU, and parent-reported worry, as were significant increases in global functioning. Based on a clinician rating, 58.3% were categorized as much or very much improved at posttreatment, rising to 66% at 3-month follow-up. Participants with generalized anxiety disorder (GAD) benefitted more from treatment than those with social anxiety disorder. The findings suggest that this IU-focused psychological intervention is acceptable and feasible to adolescents with excessive worry but may be most effective for those with GAD

Implementation of internet-delivered CBT for children with anxiety disorders in a rural area: A feasibility trial

Child anxiety disorders are highly prevalent and cause significant impairment. Cognitive behavioral therapy (CBT) is recommended for child anxiety disorders, but access to CBT is limited, particularly in rural areas. Internet-delivered CBT (ICBT) can help increase the availability of evidence-based interventions and evidence is beginning to accumulate to indicate that ICBT is efficacious for children with anxiety disorders. However, whether the results of controlled trials are transferrable to real-world clinical settings is unclear. The objective of this study was to evaluate whether therapist-guided ICBT is feasible and potentially effective when implemented in an outpatient clinic in rural Sweden. Children (N=19) aged 8–12 with anxiety disorders underwent a 12-week ICBT program called BiP Anxiety. Feasibility measures included treatment satisfaction, compliance and feedback from clinicians. Clinical outcome measures were clinician-, parent- and child ratings of anxiety symptoms and functional impairment. Overall, participants and clinicians were satisfied with the treatment content and format. There were statistically significant changes from pre- to post-treatment on the primary outcome measure (t=−4.371, p<0.001), as well as on all secondary outcome measures. Therapeutic gains were maintained for up to three months from the post-treatment assessment. At follow-up, 68% were no longer in need of treatment and could be discharged from the clinic. The study suggests the feasibility of implementing ICBT in regular health care. Implementation of ICBT could dramatically increase access to evidence based treatment for children with anxiety disorders who live far away from specialist clinics. Keywords: Child, Behavior therapy, eHealth, Anxiety disorders, Implementation, Rural health service

THE WORK AND SOCIAL ADJUSTMENT SCALE, YOUTH AND PARENT VERSIONS: PSYCHOMETRIC EVALUATION OF A BRIEF MEASURE OF FUNCTIONAL IMPAIRMENT IN YOUNG PEOPLE

Background: The Work and Social Adjustment Scale (WSAS) is a brief five-item global measure of functional impairment that is widely used as an outcome measure in adult mental health. We have adapted the WSAS for its use in youth, the WSAS-Youth version (WSAS-Y) and WSAS-Parent version (WSAS-P). This study evaluated the psychometric properties of the scale in a large sample of youth seeking help for a range of psychiatric disorders. Method: The internal consistency, factor structure, convergent and divergent validity, test-retest reliability and sensitivity to change of the WSAS-Y/P were studied in 525 children and adolescents with Obsessive-Compulsive Disorder and related disorders (including Body Dysmorphic Disorder, Tourette’s Syndrome, and body-focused repetitive behaviour disorders) receiving treatment across two specialist clinics in London and Stockholm. Results: The internal consistency of the WSAS-Y/P was excellent across diagnostic groups and time points. Exploratory factor analysis extracted a single-factor of functional impairment, explaining in excess of 85% of the variance. The test-retest reliability was adequate. As expected the WSAS-Y/P correlated more strongly with other measures of functional impairment than with measures of symptom severity, indicating good convergent/divergent validity. Finally, the WSAS-Y/P was highly sensitive to change after treatment. Conclusion: The WSAS-Y/P retains the sound psychometric properties of the original WSAS and is highly sensitive to change after treatment

Therapist-guided, Internet-delivered cognitive behaviour therapy for adolescents with body dysmorphic disorder: A feasibility trial with long-term follow-up

Body dysmorphic disorder (BDD) is a prevalent and impairing psychiatric condition that typically debuts in adolescence and is associated with risky behaviours. The disorder can be effectively treated with cognitive behaviour therapy (CBT). However, CBT for BDD is seldom available primarily due to a shortage of trained therapists. Internet-delivered CBT (ICBT) can be a way to increase treatment availability. The aim of this feasibility trial was to evaluate the feasibility, safety, and preliminary efficacy of a CBT protocol for adolescents with BDD, adapted to be delivered over the Internet with minimal therapist support. A total of 20 participants (12–17-year-olds) meeting criteria for BDD were recruited nationally to a specialist outpatient clinic in Stockholm, Sweden. One participant withdrew consent and their data could not be analysed. Nineteen participants were offered 12 modules of therapist-guided ICBT for BDD and were followed up to 12 months post-treatment. Preliminary efficacy was measured at the a priori primary endpoint (3-month follow-up) and at the 12-month follow-up with the clinician-rated Yale-Brown Obsessive Compulsive Scale Modified for BDD for Adolescents. The treatment was rated as both credible and satisfactory and was associated with a large and statistically significant reduction in BDD symptom severity (d = 2.94). The proportion of participants classified as responders at the primary endpoint was 73.7%, and the proportion of full or partial remitters was 63.2%. The average therapist support time was 8 min per participant per week. Treatment gains continued to accrue up to the 12-month follow-up. Two participants attempted suicide and another two reported non-suicidal self-injuries during the study period. ICBT with minimal therapist support is a feasible, potentially efficacious, and durable treatment for adolescents with BDD. Risky behaviours typical of this patient group should be carefully monitored during treatment

Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder : A Randomized Clinical Trial

IMPORTANCE Social anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited. OBJECTIVE To assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT). DESIGN, SETTING, AND PARTICIPANTS This single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study. INTERVENTIONS ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist. MAIN OUTCOMES AND MEASURES The Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. RESULTS Of the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.Funding Agencies|Swedish Research Council for Health, Working Life, and WelfareSwedish Research CouncilSwedish Research Council for Health Working Life &amp; Welfare (Forte) [Forte 2014-4052]; Region Stockholm [2017-0605, HNSV 14099]</p