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Abstract Background The Minimising Young Children’s Anxiety through Schools (MY-CATS) trial is being conducted to determine whether an online evidence-based parent-guided cognitive behavioural therapy intervention in addition to usual school practice is effective and cost-effective compared with usual school practice in reducing anxiety disorders in children aged 4–7 deemed ‘at risk’ of anxiety disorders. This update article describes the detailed statistical analysis plan for the MY-CATS trial and reports a review of the underpinning sample size assumptions. Methods and design The MY-CATS study is a two-arm, definitive superiority pragmatic parallel group cluster randomised controlled trial in which schools will be randomised 1:1 to receive either the intervention (in addition to usual school practice) or the usual school practice only. This update to the (published) protocol provides a detailed description of the study methods, the statistical principles, the trial population and the planned statistical analyses, including additional analyses comprising instrumental variable regression and mediation analysis. Trial registration ISRCTN82398107 . Prospectively registered on 14 January 2021

Abstract Background Identifying and supporting young children who are at risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4–7) identified as at risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention. Methods The design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4–7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at screening, baseline (before randomisation), 6 weeks, 12 weeks, and 12 months post-randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12 months. Discussion The trial will determine if delivering an online intervention for parents of young children at risk of anxiety disorders identified through screening in schools is effective and cost-effective. Trial registration ISRCTN 82398107 . Prospectively registered on Jan. 14, 2021.

High anxiety and anxiety disorders are among the most prevalent mental health problems in children and lead to significant interference with children’s daily functioning. Most empirical evaluations of treatment come from English-language countries. The aim of the present study was to evaluate and replicate the effectiveness of a cognitive-behavioral intervention program to manage anxiety in children among children from Greece. Forty-one children–parent(s) dyads participated in the study. Children were 9–12 years old, with clinically elevated symptoms of anxiety, and they were assigned to either the standard group treatment (cognitive behavior therapy (CBT)) or to a waitlist group (WL). Both children and their parents in the CBT group reported statistically significant reductions in children’s anxiety symptoms at post-intervention and at the 6-month follow-up. A significant reduction was also found in life interference due to anxiety according to both child and parent reports. In contrast, no significant changes in anxiety symptoms or life interference were reported among the WL. The current results support the effectiveness of a CBT program for anxious children from a non-clinic, non-school setting in Greece.

Abstract Background Cognitive Behavioural Therapy (CBT) is the gold standard intervention for anxiety and related mental health disorders among young people; however, the efficacy of individual elements of CBT (e.g., exposure to feared stimuli) have received little scrutiny. Aims This scoping review, informed by three stakeholder groups and a scientific advisory group, aimed to identify the nature and extent of the available research literature on the efficacy of exposure to feared stimuli, moderators of effectiveness in young people aged 14–24 years. Method Three international stakeholder groups composed of clinicians (N = 8), parents/carers (N = 5) and youth with lived experience of anxiety (N = 7) provided input into study design and results. Using the PRISMA extension for scoping reviews, a search of MEDLINE/Ovid, PsycINFO, PubMed, CINAHL, SCOPUS, EMBASE, ERIC, and Health Collection (informit) was conducted using terms related to anxiety, ages 14–24, and exposure. Results From 3508 unique abstracts, 64 papers were included for the review. While there was evidence for the efficacy of exposure as a treatment for youth anxiety disorders, fundamental gaps in knowledge of exposure in this age group were identified. Most studies examined post‐traumatic stress disorder, obsessive–compulsive disorder, and specific phobias with no randomised clinical trials uniquely evaluating exposure for the treatment of DSM‐5 anxiety disorders. Exposure was typically delivered accompanied by other anxiety management techniques. A multitude of optimisation strategies have been tested, yet only one of these effects (timing relative to sleep) showed preliminary evidence of replication. Conclusions A systematic and theoretically driven program of research investigating the efficacy of exposure in young people and factors that moderate its efficacy, along with methods to overcome barriers for delivery, is urgently needed.

Abstract Background This study explored whether temperamentally inhibited children who experience early trauma are vulnerable to developing internalizing problems in the face of later life-stressors. Methods A validated screen for temperamental inhibition was distributed to parents of young children attending preschools in six government regions of Melbourne, Australia. Screening identified 11% of children as inhibited (703 of 6347 screened) and eligible for a prevention study. Participants were 545 parents of inhibited preschoolers (78% uptake), of whom 84% were followed into mid childhood (age 7–10 years: wave 1, n = 446; wave 2, n = 427; wave 3, n = 426). Parents and children then completed questionnaires for child internalizing (anxious and depressive) symptoms, and parents received a diagnostic interview for child anxiety disorder. In mid-childhood parents also completed questionnaires annually to describe recent life-stressors experienced by their child, and any potentially traumatic events in the first four years of life. Results Only one in 14 temperamentally inhibited children had experienced a potentially traumatic event in early childhood. In mid childhood 56% experienced recent life-stressors. Inhibited children who had early life trauma experienced slightly more anxiety disorder and symptoms in mid childhood. Those children with more recent life-stressors in mid childhood also had slightly more symptoms of anxiety and depression. In contrast to stress sensitization, inhibited children with early trauma plus recent stressors did not show especially high mid-childhood internalizing difficulties. Conclusions Early life trauma and recent life-stressors each convey a small risk for children with an inhibited temperament to develop internalizing problems. Nevertheless, early life stress may not always result in negative sensitization for children in the general population.

Background Increasing both the frequency and quality of social interactions within treatments for anxiety and depressive disorders in older adults may improve their mental health outcomes and quality of life. This study aims to evaluate the clinical efficacy and cost utility of an enhanced cognitive behavioural therapy (CBT) plus social participation program in a sample of older adults with depression and/or anxiety. Methods A total of 172 community-dwelling adults aged 65 years or older with an anxiety and/or depressive disorder will be randomly allocated to either an enhanced CBT plus social participation program (n = 86) or standard CBT (n = 86). Both treatments will be delivered during 12 weekly individual sessions utilising structured manuals and workbooks. Participants will be assessed at pre-treatment, post-treatment, and 12-month follow-up. The primary outcome evaluates mean change in clinician-rated diagnostic severity of anxiety and depressive disorders from baseline to post-treatment (primary endpoint) based on a semi-structured diagnostic interview. Secondary outcomes evaluate changes in symptomatology on self-report anxiety and depression measures, as well as changes in social/community participation, social network, and perceived social support, loneliness, quality of life, and use of health services. Economic benefits will be evaluated using a cost-utility analysis to derive the incremental cost utility ratios for the enhanced CBT program. Discussion Outcomes from this study will provide support for the establishment of improved psychosocial treatment for older adults with anxiety and/or depression. Study outcomes will also provide health systems with a clear means to reduce the impact of poor emotional health in older age and its associated economic burden. In addition to the empirical validation of a novel treatment, the current study will contribute to the current understanding of the role of social participation in older adult wellbeing. Trial registration Prospectively registered on the Australian New Zealand Clinical Trials Registry (ID: ACTRN12619000242123; registered 19th February 2019) and the ISRCTN registry (ID: ISRCTN78951376; registered 10th July 2019).

Abstract Background Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. Methods This RCT is recruiting children aged 8–12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child’s parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. Discussion The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. Trial registration This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (https://doi.org/10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19.

There is limited knowledge about sleep in adolescents with elevated levels of anxiety treated within primary health care settings, potentially resulting in sleep problems not being sufficiently addressed by primary health care workers. In the current study self-reported anxiety, insomnia, sleep onset latency, sleep duration, and depressive symptoms were assessed in 313 adolescents (12–16 years; mean age 14.0, SD = 0.84, 84.0% girls) referred to treatment for anxiety within primary health care. Results showed that 38.1% of the adolescents met criteria for insomnia, 34.8% reported short sleep duration (

Background: Evidence suggests that adolescents with comorbid anxiety and depression are a high-risk group in terms of symptom severity, life quality and prognosis, with unique treatment needs compared to their peers who meet criteria for a single diagnosis. The current study evaluated the efficacy of a transdiagnostic treatment designed specifically to target shared mechanisms underlying comorbid anxiety and depression in adolescents. Method: Eighty-two adolescents (12–17 years) with a concurrent diagnosis of an anxiety and a mood disorder were randomly allocated to either active treatment or wait-list. Effects on diagnoses, symptoms and life interference were assessed at post-treatment, 6- and 12-month follow-up based on reports from both the young person and parents. Results: Compared to waitlist, treatment was associated with a significantly greater reduction in total number of diagnoses and clinician rated severity of diagnoses over time. Life interference also showed significantly greater improvement in active treatment compared to wait-list, however other self and parent-reported indicators improved significantly but similarly over time in both groups. Effects were maintained at 6- and 12-month follow up. Conclusions: The transdiagnostic package targeting common underlying mechanisms demonstrated reductions in anxiety and depression in adolescents on key measures, including diagnostic criteria and life interference and shows promise as an efficacious treatment for comorbid anxiety and depression in adolescents. The outcomes point to a valuable initial program for clinical use, although further development will be needed to strengthen effects.

Abstract Background Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. Methods This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre–post assessment) mixed between–within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child’s level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child’s behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. Discussion This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. Trial registration https://ClinicalTrials.gov (NCT02908321). Registered 19th of September 2016.

Objective: To develop a theoretically grounded measure of self-perceived ability to cope with stress in a flexible (i.e. non-rigid) manner and test associations with well-being. Method: Participants in Study 1 (N = 395, 17–56 years) completed surveys to report flexible coping with stress and well-being. In Studies 2 (N = 645, 17–27 years) and 3 (N = 558, 12–19 years), youth completed surveys with the 18-item Self-Perception of Flexible Coping with Stress (SFCS), and coping and well-being measures. Results: Three SFCS factors were supported, which aligned to the conceptualization including multiple coping strategy use (multiple CSU), coping rigidity, and situational coping. The SFCS subscales had good reliability and were modestly correlated with each other. Also, multiple CSU and situational coping were linked to better mental health, emotion regulation, greater use of adaptive coping strategies, and better self-worth. Coping rigidity was linked with more symptoms of anxiety and depression, more emotion dysregulation, greater use of problem-coping behaviors, and lower self-worth. Older participants reported they were higher in flexible coping and sex differences in multiple CSU and situational coping were found. Conclusions. The SFCS, a measure of the deployment of a coping “toolbox” that could allow individuals to respond adroitly to stressors, is reliable, valid, and associated with well-being.

Anxiety disorders are common, debilitating, and begin early in life. Early intervention to prevent anxiety disorders in children who are at risk could have long-term impact. The ‘Cool Little Kids’ parenting group program has previously been shown to be efficacious in preventing anxiety disorders in temperamentally inhibited young children. Wider dissemination of the program could be achieved with an internet-based delivery platform, affording greater accessibility and convenience for parents. The aim of this study was to evaluate ‘Cool Little Kids Online’, a newly developed online version of the existing parenting group program. Fifty-one parents of children aged 3–6 years were recruited to evaluate the online program's acceptability and preliminary efficacy in reducing inhibited young children's anxiety problems. Parents were randomized to receive either a clinician-supported version or an unsupported version of the program. Parents had 10 weeks to access the program and completed questionnaires at baseline and post-intervention. Both groups showed medium-to-large reductions in children's anxiety symptoms, emotional symptoms, number of child anxiety diagnoses, and improvements in life interference from anxiety. The effect of clinician support was inconsistent and difficult to interpret. Parents reported high levels of satisfaction with the program. These encouraging results indicate that the online version is acceptable and useful for parents with temperamentally inhibited young children. Cool Little Kids Online may be a promising direction for improving access to an evidence-based prevention and early intervention program for child anxiety problems. A large randomized trial is warranted to further evaluate efficacy.

This study examines whether combined cognitive bias modification for interpretative biases (CBM-I) and computerised cognitive behaviour therapy (C-CBT) can produce enhanced positive effects on interpretation biases and social anxiety. Forty socially anxious students were randomly assigned into two conditions, an intervention group (positive CBM-I + C-CBT) or an active control (neutral CBM-I + C-CBT). At pre-test, participants completed measures of social anxiety, interpretative bias, cognitive distortions, and social and work adjustment. They were exposed to 6 × 30 min sessions of web-based interventions including three sessions of either positive or neutral CBM-I and three sessions of C-CBT, one session per day. At post-test and two-week follow-up, participants completed the baseline measures. A combined positive CBM-I + C-CBT produced less negative interpretations of ambiguous situations than neutral CBM-I + C-CBT. The results also showed that both positive CBM-I + C-CBT and neutral CBM-I + C-CBT reduced social anxiety and cognitive distortions as well as improving work and social adjustment. However, greater effect sizes were observed in the positive CBM-I + C-CBT condition than the control. This indicates that adding positive CBM-I to C-CBT enhanced the training effects on social anxiety, cognitive distortions, and social and work adjustment compared to the neutral CBM-I + C-CBT condition.

Identification of possible cases suffering post-traumatic stress disorder (PTSD) is important, especially in developing countries where traumatic events are typically prevalent. The Children’s Revised Impact of Events Scale is a reliable and valid measure that has two brief versions (13 items and 8 items) to assess reactions to traumatic events among young people. The current study evaluated the psychometric properties of both versions of the CRIES in a sample of 1,342 children and adolescents aged 9–17 years (M = 12.3 years, SD = 2.12) recruited from six districts of Bangladesh. A sub-group of 120 children from four schools was re-tested on the measures within 3.5 weeks. Confirmatory factor analysis supported factor structures similar to those found in other studies for both versions of the CRIES. Multiple group confirmatory factor analysis showed gender and age-group differences within the sample, supporting established age and gender differences in prevalence of PTSD symptoms. Analyses also indicated moderate to excellent internal consistency and test-retest reliability and clear discriminant and convergent validity. These data support use of both the CRIES-13 and CRIES-8 to provide quick and psychometrically sound assessment of symptoms of PTSD among children and adolescents from Bangla-speaking communities.

Introduction Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression.Methods and analysis University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) × 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models.Ethics and dissemination The current study was approved by the Medical Ethics Review Committee (METC) of the Academic Medical Centre, Amsterdam, The Netherlands (number: NL64929.018.18). Results of this trial will be published in peer-reviewed journals.Trial registration number NL7328.

Introduction The primary objective of the Multi-, Inter-, and Cross-cultural Clinical Child Study (MIXCS) is to evaluate the hypothesis that the effects of cultural-adapted cognitive behavioural therapy (CA-CBT) and programme-adopted cognitive behavioural therapy (PA-CBT) for children and adolescents’ anxiety are both superior to a psychological control (moral education control: MEC) for reducing child and adolescent anxiety disorders and symptoms as well as related constructs. The secondary objective is to explore commonalities and differences in therapy factors between CA-CBT and PA-CBT.Method and analysis The study has been designed as a randomised, controlled and assessor masked multicentre superiority trial with three groups: CA-CBT, PA-CBT and MEC. Primary outcome is remission of primary anxiety disorders evaluated by independent evaluators. Secondary outcomes are clinician’s severity ratings, child self-reported anxiety symptoms, depressive symptoms, cognitive errors and family accommodation, as well as parent-reported anxiety symptoms, and family accommodation. Competence and adherence of treatment, therapy factors in treatment sessions are also measured based on behavioural observation. Finally, satisfaction and comprehension are collected. We aim to recruit at least 99 families for the analysis. Treatment will be delivered weekly for 10 sessions and assessment will be conducted 2 weeks before the treatment (pre), 3 months after the base date when the treatment starts (post), 6 months (six months follow-up) and 12 months (12 months follow-up) after the postassessment.Ethics and dissemination The MIXCS study was approved by Doshisha University Research Ethics Review Committee, Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subjects and Shinshu University Certified Review Board of Clinical Research. Regardless of the results, the primary outcome will be published in a journal, and if the efficacy and effectiveness of CA-CBT and/or PA-CBT are empirically supported, the authors will encourage dissemination of the programmes including the assessment system through key stakeholders in education, health, and welfare areas.Trial registration number UMIN000038128

BackgroundIncreasing both the frequency and quality of social interactions within treatments for anxiety and depressive disorders in older adults may improve their mental health outcomes and quality of life. This study aims to evaluate the clinical efficacy and cost utility of an enhanced cognitive behavioural therapy (CBT) plus social participation program in a sample of older adults with depression and/or anxiety.MethodsA total of 172 community-dwelling adults aged 65 years or older with an anxiety and/or depressive disorder will be randomly allocated to either an enhanced CBT plus social participation program (n = 86) or standard CBT (n = 86). Both treatments will be delivered during 12 weekly individual sessions utilising structured manuals and workbooks. Participants will be assessed at pre-treatment, post-treatment, and 12-month follow-up. The primary outcome evaluates mean change in clinician-rated diagnostic severity of anxiety and depressive disorders from baseline to post-treatment (primary endpoint) based on a semi-structured diagnostic interview. Secondary outcomes evaluate changes in symptomatology on self-report anxiety and depression measures, as well as changes in social/community participation, social network, and perceived social support, loneliness, quality of life, and use of health services. Economic benefits will be evaluated using a cost-utility analysis to derive the incremental cost utility ratios for the enhanced CBT program.DiscussionOutcomes from this study will provide support for the establishment of improved psychosocial treatment for older adults with anxiety and/or depression. Study outcomes will also provide health systems with a clear means to reduce the impact of poor emotional health in older age and its associated economic burden. In addition to the empirical validation of a novel treatment, the current study will contribute to the current understanding of the role of social participation in older adult wellbeing.Trial registrationProspectively registered on the Australian New Zealand Clinical Trials Registry (ID: ACTRN12619000242123; registered 19th February 2019) and the ISRCTN registry (ID: ISRCTN78951376; registered 10th July 2019).

BACKGROUND:Fear of negative evaluation (FNE) defines social anxiety yet the process of inferring social evaluation, and its potential role in maintaining social anxiety, is poorly understood. We developed an instrumental learning task to model social evaluation learning, predicting that FNE would specifically bias learning about the self but not others. METHODS:During six test blocks (3 self-referential, 3 other-referential), participants (n = 100) met six personas and selected a word from a positive/negative pair to finish their social evaluation sentences "I think [you are / George is]…". Feedback contingencies corresponded to 3 rules, liked, neutral and disliked, with P[positive word correct] = 0.8, 0.5 and 0.2, respectively. RESULTS:As FNE increased participants selected fewer positive words (β = -0.4, 95% CI -0.7, -0.2, p = 0.001), which was strongest in the self-referential condition (FNE × condition 0.28, 95% CI 0.01, 0.54, p = 0.04), and the neutral and dislike rules (FNE × condition × rule, p = 0.07). At low FNE the proportion of positive words selected for self-neutral and self-disliked greatly exceeded the feedback contingency, indicating poor learning, which improved as FNE increased. CONCLUSIONS:FNE is associated with differences in processing social-evaluative information specifically about the self. At low FNE this manifests as insensitivity to learning negative self-referential evaluation. High FNE individuals are equally sensitive to learning positive or negative evaluation, which although objectively more accurate, may have detrimental effects on mental health.

BACKGROUND: A recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment, the Wellbeing Course, for symptoms of anxiety or depression. This study found the intervention resulted in significant symptom reductions. It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression. AIMS: To examine the clinical outcomes and the effect of automated emails at 12 months post-treatment. METHOD: Participants, who were randomly allocated to a Treatment Plus Automated Emails Group (TEG; n = 100), a standard Treatment Group (TG; n = 106) or delayed-treatment Waitlist Control Group (Control; n = 51), were followed up at 12 months post-treatment. Eighty-one percent, 78% and 87% of participants in the TEG, TG and treated Waitlist Control Group provided symptom data at 12-month follow-up, respectively. The primary outcome measures were the Patient Health Questionnaire-9 Item Scale (PHQ-9) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7). RESULTS: Significant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG (Fs >69, ps .05), and were associated with large effect sizes. No statistically significant differences in symptoms were found between the TEG and TG at post-treatment, 3-month or 12-month follow-up. Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up (ps >.70). CONCLUSIONS: The overall benefits of the Wellbeing Course were sustained at 12-month follow-up. Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment, these differences were no longer observed at 12-month follow-up. The results indicate that automated emails promote more rapid treatment response for people with elevated and comorbid symptoms, but may not improve longer term outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610001058066.

BackgroundDepression and anxiety are common, disabling and chronic. Self-guided internet-delivered treatments are popular, but few people complete them. New strategies are required to realise their potential.AimsTo evaluate the effect of automated emails on the effectiveness, safety, and acceptability of a new automated transdiagnostic self-guided internet-delivered treatment, the Wellbeing Course, for people with depression and anxiety.MethodA randomised controlled trial was conducted through the website: www.ecentreclinic.org. Two hundred and fifty seven people with elevated symptoms were randomly allocated to the 8 week course either with or without automated emails, or to a waitlist control group. Primary outcome measures were the Patient Health Questionnaire 9-Item (PHQ-9) and the Generalized Anxiety Disorder 7-Item (GAD-7).ResultsParticipants in the treatment groups had lower PHQ-9 and GAD-7 scores at post-treatment than controls. Automated emails increased rates of course completion (58% vs. 35%), and improved outcomes in a subsample with elevated symptoms.ConclusionsThe new self-guided course was beneficial, and automated emails facilitated outcomes. Further attention to strategies that facilitate adherence, learning, and safety will help realise the potential of self-guided interventions.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610001058066.