Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial.

BACKGROUND: Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions. OBJECTIVE: The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists' competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India. METHODS: We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India. RESULTS: Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022. CONCLUSIONS: The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41981.

Estimating the change in meta-analytic effect size estimates after the application of publication bias adjustment methods.

Publication bias poses a challenge for accurately synthesizing research findings using meta-analysis. A number of statistical methods have been developed to combat this problem by adjusting the meta-analytic estimates. Previous studies tended to apply these methods without regard to optimal conditions for each method's performance. The present study sought to estimate the typical effect size attenuation of these methods when they are applied to real meta-analytic data sets that match the conditions under which each method is known to remain relatively unbiased (such as sample size, level of heterogeneity, population effect size, and the level of publication bias). Four-hundred and 33 data sets from 90 articles published in psychology journals were reanalyzed using a selection of publication bias adjustment methods. The downward adjustment found in our sample was minimal, with greatest identified attenuation of b = -.032, 95% highest posterior density interval (HPD) ranging from -.055 to -.009, for the precision effect test (PET). Some methods tended to adjust upward, and this was especially true for data sets with a sample size smaller than 10. We propose that researchers should seek to explore the full range of plausible estimates for the effects they are studying and note that these methods may not be able to combat bias in small samples (with less than 10 primary studies). We argue that although the effect size attenuation we found tended to be minimal, this should not be taken as an indication of low levels of publication bias in psychology. We discuss the findings with reference to new developments in Bayesian methods for publication bias adjustment, and the recent methodological reforms in psychology. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Assessing bidirectional relations between infant temperamental negative affect, maternal anxiety symptoms and infant affect-biased attention across the first 24-months of life.

Developmental theories suggest affect-biased attention, preferential attention to emotionally salient stimuli, emerges during infancy through coordinating individual differences. Here we examined bidirectional relations between infant affect-biased attention, temperamental negative affect, and maternal anxiety symptoms using a Random Intercepts Cross-Lagged Panel model (RI-CLPM). Infant-mother pairs from Central Pennsylvania and Northern New Jersey (N = 342; 52% White; 50% reported as assigned female at birth) participated when infants were 4, 8, 12, 18 and 24 months of age. Infants completed the overlap task while eye-tracking data were collected. Mothers reported their infant's negative affect and their own anxiety symptoms. In an RI-CLPM, after accounting for between-person variance (random intercepts representing the latent average of a construct), it is possible to assess within-person variance (individual deviations from the latent average of a construct). Positive relations represent stability in constructs (smaller within-person deviations). Negative relations represent fluctuation in constructs (larger within-person deviations). At the between-person level (random intercepts), mothers with greater anxiety symptoms had infants with greater affect-biased attention. However, at the within-person level (deviations), greater fluctuation in maternal anxiety symptoms at 12- and 18 months prospectively related to greater stability in attention to angry facial configurations. Additionally, greater fluctuation in maternal anxiety symptoms at 18 months prospectively related to greater stability in attention to happy facial configurations. Finally, greater fluctuation in maternal anxiety symptoms at 4- and 12 months prospectively related to greater stability in infant negative affect. These results suggest that environmental uncertainty, linked to fluctuating maternal anxiety, may shape early socioemotional development. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Developing knowledge-based psychotherapeutic competencies in non-specialist providers: A pre-post study with a nested randomised controlled trial of a coach-supported versus self-guided digital training course for a problem-solving psychological intervention in India.

We evaluated a digital learning programme for non-specialists to develop knowledge-based competencies in a problem-solving intervention for adolescents to examine the overall impact of training on knowledge-based competencies among learners; and to compare the effects of two training conditions (self-guided digital training with or without coaching) in a nested parallel, two-arm, individually randomised controlled trial. Eligible participants were 18 or older; fluent in Hindi or English; able to access digital training; and had no prior experience of delivering structured psychotherapies. 277 participants were enrolled from 31 March 2022 to 19 June 2022 of which 230 (83%) completed the study. There was a significant increase in competency score from pre-training (Mean = 7.01, SD = 3.29) to post-training (Mean = 8.88, SD = 3.80), 6 weeks after the pre-training assessment. Knowledge competency scores showed larger increase among participants randomised to the coaching arm (AMD = 1.09, 95% CI 0.26-1.92, p = 0.01) with an effect size (d) of 0.33 (95% CI 0.08-0.58). More participants completed training in the coaching arm (n = 96, 69.6%) compared to the self-guided training arm (n = 56, 40.3%). In conclusion, a coach-supported remote digital training intervention is associated with enhanced participation by learners and increased psychotherapeutic knowledge competencies.

Health Care Workers' Need for Headspace: Findings From a Multisite Definitive Randomized Controlled Trial of an Unguided Digital Mindfulness-Based Self-help App to Reduce Healthcare Worker Stress.

BACKGROUND: Health care workers experience high stress. Accessible, affordable, and effective approaches to reducing stress are lacking. In-person mindfulness-based interventions can reduce health care worker stress but are not widely available or accessible to busy health care workers. Unguided, digital, mindfulness-based self-help (MBSH) interventions show promise and can be flexibly engaged with. However, their effectiveness in reducing health care worker stress has not yet been explored in a definitive trial. OBJECTIVE: This study aimed to investigate the effectiveness of an unguided digital MBSH app (Headspace) in reducing health care worker stress. METHODS: This was a definitive superiority randomized controlled trial with 2182 National Health Service staff in England recruited on the web and allocated in a 1:1 ratio to fully automated Headspace (n=1095, 50.18%) or active control (Moodzone; n=1087, 49.82%) for 4.5 months. Outcomes were subscales of the Depression, Anxiety, and Stress (primary outcome) Scale short form; Short Warwick Edinburgh Mental Well-being Scale; Maslach Burnout Inventory; 15-item Five-Facet Mindfulness Questionnaire minus Observe items; Self-Compassion Scale-Short Form; Compassionate Love Scale; Penn State Worry Questionnaire; Brooding subscale of the Ruminative Response Scale; and sickness absence. RESULTS: Intention-to-treat analyses found that Headspace led to greater reductions in stress over time than Moodzone (b=-0.31, 95% CI -0.47 to -0.14; P<.001), with small effects. Small effects of Headspace versus Moodzone were found for depression (b=-0.24, 95% CI -0.40 to -0.08; P=.003), anxiety (b=-0.19, 95% CI -0.32 to -0.06; P=.004), well-being (b=0.14, 95% CI 0.05-0.23; P=.002), mindfulness (b=0.22, 95% CI 0.09-0.34; P=.001), self-compassion (b=0.48, 95% CI 0.33-0.64; P<.001), compassion for others (b=0.02, 95% CI 0.00-0.04; P=.04), and worry (b=-0.30, 95% CI -0.51 to -0.09; P=.005) but not for burnout (b=-0.19, -0.04, and 0.13, all 95% CIs >0; P=.65, .67, and .35), ruminative brooding (b=-0.06, 95% CI -0.12 to 0.00; P=.06), or sickness absence (γ=0.09, 95% CI -0.18 to 0.34). Per-protocol effects of Headspace (454/1095, 41.46%) versus Moodzone (283/1087, 26.03%) over time were found for stress, self-compassion, and compassion for others but not for the other outcomes. Engagement (practice days per week) and improvements in self-compassion during the initial 1.5-month intervention period mediated pre- to postintervention improvements in stress. Improvements in mindfulness, rumination, and worry did not mediate pre- to postintervention improvements in stress. No serious adverse events were reported. CONCLUSIONS: An unguided digital MBSH intervention (Headspace) can reduce health care workers' stress. Effect sizes were small but could have population-level benefits. Unguided digital MBSH interventions can be part of the solution to reducing health care worker stress alongside potentially costlier but potentially more effective in-person mindfulness-based interventions, nonmindfulness courses, and organizational-level interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15424185; https://tinyurl.com/rv9en5kc.

Developmental patterns of affective attention across the first 2 years of life.

This study examined patterns of attention toward affective stimuli in a longitudinal sample of typically developing infants (N = 357, 147 females, 50% White, 22% Latinx, 16% African American/Black, 3% Asian, 8% mixed race, 1% not reported) using two eye-tracking tasks that measure vigilance to (rapid detection), engagement with (total looking toward), and disengagement from (latency to looking away) emotional facial configurations. Infants completed each task at 4, 8, 12, 18, and 24 months of age from 2016 to 2020. Multilevel growth models demonstrate that, over the first 2 years of life, infants became faster at detecting and spent more time engaging with angry over neutral faces. These results have implications for our understanding of the development of affect-biased attention.

Moderating effects of environmental stressors on the development of attention to threat in infancy.

An attention bias to threat has been linked to psychosocial outcomes across development, including anxiety (Pérez-Edgar, K., Bar-Haim, Y., McDermott, J. M., Chronis-Tuscano, A., Pine, D. S., & Fox, N. A. (2010). Attention biases to threat and behavioral inhibition in early childhood shape adolescent social withdrawal. Emotion (Washington, D.C.), 10(3), 349). Although some attention biases to threat are normative, it remains unclear how these biases diverge into maladaptive patterns of emotion processing for some infants. Here, we examined the relation between household stress, maternal anxiety, and attention bias to threat in a longitudinal sample of infants tested at 4, 8, and 12 months. Infants were presented with a passive viewing eye-tracking task in which angry, happy, or neutral facial configurations appeared in one of the four corners of a screen. We measured infants' latency to fixate each target image and collected measures of parental anxiety and daily hassles at each timepoint. Intensity of daily parenting hassles moderated patterns of attention bias to threat in infants over time. Infants exposed to heightened levels of parental hassles became slower to detect angry (but not happy) facial configurations compared with neutral faces between 4 and 12 months of age, regardless of parental anxiety. Our findings highlight the potential impact of the environment on the development of infants' early threat processing and the need to further investigate how early environmental factors shape the development of infant emotion processing.

What's Worrying Our Students? Increasing Worry Levels over Two Decades and a New Measure of Student Worry Frequency and Domains.

BACKGROUND: The frequency and severity of mental health problems in student populations have been a growing cause for concern worldwide, and studies have identified measures of a number of mental health symptoms that have been steadily increasing in frequency and intensity over the past 20-25 years. METHODS: In two studies we investigate the levels and domains of pathological worrying in university student participants. Study 1 is a retrospective study of Penn State Worry Questionnaire (PSWQ) data collected between 2001 and 2019. Study 2 describes the development of the Student Worry Questionnaire, a short and easily delivered measure of student worrying that identifies both frequency of worry as well as the student-relevant domains across which worrying occurs. RESULTS: Study 1 revealed a steady increase in student worry scores of around 20% between 2001 and 2019, with a significant positive correlation between year of data collection and mean PSWQ score. The domain scores in Study 2 indicated that academic work was a significantly higher worry than any of the other domains, and worries about intimate relationships and 'what people think of me' were also worries that scored higher than either financial or health worries. CONCLUSIONS: The present studies indicate that pathological worrying can be added to the list of anxiety- and stress-related symptoms that have been shown to be on the increase in student populations in recent decades, and we discuss whether these increases represent a greater willingness to report symptoms or a genuine increase in experienced symptoms over time.

Study Protocol: Longitudinal Attention and Temperament Study.

Background: Attention processes may play a central role in shaping trajectories of socioemotional development. Individuals who are clinically anxious or have high levels of trait anxiety sometimes show attention biases to threat. There is emerging evidence that young children also demonstrate a link between attention bias to salient stimuli and broad socioemotional profiles. However, we do not have a systematic and comprehensive assessment of how attention biases, and associated neural and behavioral correlates, emerge and change from infancy through toddlerhood. This paper describes the Longitudinal Attention and Temperament study (LAnTs), which is designed to target these open questions. Method: The current study examines core components of attention across the first 2 years of life, as well as measures of temperament, parental psychosocial functioning, and biological markers of emotion regulation and anxiety risk. The demographically diverse sample (N = 357) was recruited from the area surrounding State College, PA, Harrisburg, PA, and Newark, NJ. Infants and parents are assessed at 4, 8, 12, 18, and 24 months. Assessments include repeated measures of attention bias (via eye-tracking) in both infants and parents, and measures of temperament (reactivity, negative affect), parental traits (e.g., anxiety and depression), biological markers (electrophysiology, EEG, and respiratory sinus arrythmia, RSA), and the environment (geocoding, neighborhood characteristics, perceived stress). Outcomes include temperamental behavioral inhibition, social behavior, early symptom profiles, and cellular aging (e.g., telomere length). Discussion: This multi-method study aims to identify biomarkers and behavioral indicators of attentional and socioemotional trajectories. The current study brought together innovative measurement techniques to capture the earliest mechanisms that may be causally linked to a pervasive set of problem behaviors. The analyses the emerge from the study will address important questions of socioemotional development and help shape future research. Analyses systematically assessing attention bias patterns, as well as socioemotional profiles, will allow us to delineate the time course of any emerging interrelations. Finally, this study is the first to directly assess competing models of the role attention may play in socioemotional development in the first years of life.

Maths attitudes, school affect and teacher characteristics as predictors of maths attainment trajectories in primary and secondary education.

Maths attainment is essential for a wide range of outcomes relating to further education, careers, health and the wider economy. Research suggests a significant proportion of adults and adolescents are underachieving in maths within the UK, making this a key area for research. This study investigates the role of children's perceptions of the school climate (children's affect towards school and student-teacher relationships), their attitudes towards maths and teacher characteristics as predictors of maths attainment trajectories, taking the transition from primary to secondary education into consideration. Two growth models were fit using secondary data analysis of the Avon Longitudinal Study of Parents and Children (ALSPAC). The first model, which looked at predictors of maths attainment in primary education, found significant associations only between positive maths attitudes and increased maths attainment. The second model, which looked at predictors of maths attainment in secondary education, found significant associations between increased maths attainment and positive maths attitudes, decreased school belonging, positive student-teacher relationships and increased teacher fairness. The findings suggest that the secondary education school environment is particularly important for maths attainment.

Predictors of mathematical attainment trajectories across the primary-to-secondary education transition: parental factors and the home environment.

A 'maths crisis' has been identified in the UK, with many adults and adolescents underachieving in maths and numeracy. This poor performance is likely to develop from deficits in maths already present in childhood. Potential predictors of maths attainment trajectories throughout childhood and adolescence relate to the home environment and aspects of parenting including parent-child relationships, parental mental health, school involvement, home teaching, parental education and gendered play at home. This study examined the aforementioned factors as predictors of children's maths attainment trajectories (age 7-16) across the challenging transition to secondary education. A secondary longitudinal analysis of the Avon Longitudinal Study of Parents and Children found support for parental education qualifications, a harmonious parent-child relationship and school involvement at age 11 as substantial predictors of maths attainment trajectories across the transition to secondary education. These findings highlight the importance of parental involvement for maths attainment throughout primary and secondary education.

The importance of using multiple outcome measures in infant research.

Collecting data with infants is notoriously difficult. As a result, many of our studies consist of small samples, with only a single measure, in a single age group, at a single time point. With renewed calls for greater academic rigor in data collection practices, using multiple outcome measures in infant research is one way to increase rigor, and, at the same time, enable us to more accurately interpret our data. Here, we illustrate the importance of using multiple measures in psychological research with examples from our own work on rapid threat detection and from the broader infancy literature. First, we describe our initial studies using a single outcome measure, and how this strategy caused us to nearly miss a rich and complex story about attention biases for threat and their development. We demonstrate how using converging measures can help researchers make inferences about infant behavior, and how using additional measures allows us to more deeply examine the mechanisms that drive developmental change. Finally, we provide practical and statistical recommendations for how researchers can use multiple measures in future work.

Maternal and paternal influences on childhood anxiety symptoms: A genetically sensitive comparison.

This study tested the theory that anxious fathers pose a quantitatively different environmental influence on childhood anxiety than anxious mothers. The analysed sample contained 502 linked adoption units from the Early Growth and Development Study (EGDS), a longitudinal multisite study that follows 561 adopted children (57.2% boys) and their adoptive and birth parents, who were recruited through US adoption agencies. A Bayesian latent growth model predicted child anxiety symptoms between 18 months and 4.5 years from inherited (birth parent anxiety) and rearing parent anxiety. This model revealed little evidence for a difference in the influence of maternal and paternal rearing parent anxiety on child anxiety symptoms. Contrary to theoretical predictions, anxiety in the rearing father is likely to have an equivalent influence to that of the mother on both child anxiety symptoms at 18 months old and their developmental trajectory over the preschool years.

Internalizing symptoms and working memory as predictors of mathematical attainment trajectories across the primary-secondary education transition.

The transition from primary to secondary education is a critical period in early adolescence which is related to increased anxiety and stress, increased prevalence of mental health issues, and decreased maths performance, suggesting it is an important period to investigate maths attainment. Previous research has focused on anxiety and working memory as predictors of maths, without investigating any long-term effects around the education transition. This study examined working memory and internalizing symptoms as predictors of children's maths attainment trajectories (age 7-16) across the transition to secondary education using secondary longitudinal analysis of the Avon Longitudinal Study of Parents and Children (ALSPAC). This study found statistically significant, but very weak evidence for the effect of internalizing symptoms and working memory on maths attainment. Greater parental education was the strongest predictor, suggesting that children of parents with a degree (compared with those with a CSE) gain the equivalent of almost a year's schooling in maths. However, due to methodological limitations, the effects of working memory and internalizing symptoms on attainment cannot be fully understood with the current study. Additional research is needed to further uncover this relationship, using more time-appropriate measures.

Predicting maths anxiety from mathematical achievement across the transition from primary to secondary education.

The primary- to secondary-education transition is a substantive life event for many children. The transition can be associated with changes in the developmental trajectories of both emotional health and academic achievement. The current study looked at whether the trajectory of mathematical attainment and emotional health (anxiety) across this transition predicted later maths anxiety. A secondary analysis of data from the Twin Early Development Study (TEDS) was performed. The statistical models were fit on the 753 participants (one from each twin pair) for which there were measures of mathematical performance across the primary- to secondary-education transition and maths anxiety at age 18. Two multi-level growth models were fit predicting mathematical attainment and anxiety over the primary- to secondary-education transition. The intercepts and slopes for each child were extracted from these models and used as predictors of subsequent maths anxiety at age 18. These effects were adjusted for biological sex, socio-economic status, verbal cognitive ability and general anxiety. Maths anxiety at age 18 was significantly predicted by both pre-transition levels of anxiety and mathematical attainment and their rate of change across the primary- to secondary-education transition. However, the effects were small, suggesting that theories of maths anxiety may have overplayed the role of prior mathematical attainment and general anxiety.

A meta-analysis of memory ability in synaesthesia.

People with synaesthesia (e.g., experiencing colours for letters and numbers) have been reported to possess enhanced memory relative to the general population. However, there are also inconsistencies in this literature and it is unclear whether this reflects sampling error (exacerbated by low Ns) or more meaningful differences that arise because synaesthesia relates to some aspects of memory more than others. To this end, a multi-level meta-analysis was conducted. Synaesthetes have enhanced long-term (episodic) memory with a medium population effect size ( dˆ = 0.61), whereas the effects on working memory (short-term memory) were significantly smaller ( dˆ = 0.36) but still exceeded that of controls. Moderation analyses suggested that, aside from the division between long-term vs. working memory, the effects of synaesthesia are pervasive, i.e., they extend to all kinds of stimuli, and extend to all kinds of test formats. This pattern is hard to reconcile with the view that synaesthetic experiences directly support memory ability: for instance, digit span (where synaesthesia could be helpful) showed a small effect whereas episodic memory for abstract images (where synaesthesia is irrelevant) yielded larger effects. Synaesthesia occupies a unique position of being the only known neurodevelopmental condition linked to a pervasive enhancement of long-term memory.

The impact of affective information on working memory: A pair of meta-analytic reviews of behavioral and neuroimaging evidence.

Everyday life is defined by goal states that are continuously reprioritized based on available, often affective information. To pursue these goals, individuals need to process and maintain goal-relevant information, while ignoring potentially salient information that distracts resources from these goals. Empirically, this ability has typically been operationalized as working memory (WM) capacity. A growing body of research is investigating the impact of information's affective salience on WM capacity. In the present review we address this question by exploring the potential differential impact of affective compared with neutral information on WM, and the underlying neural substrates. One-hundred and 65 studies (N = 7,433) were included in the meta-analysis. Results showed negligible to small (d̂ = -.07-.20) effects of affective information on behavioral measures of WM in healthy individuals (n = 4,936) that varied as a function of valence and task-relevance. Heterogeneity analyses were significant, demonstrating the need to identify further study-specific factors and individual differences that moderate affective WM. At the neural level (33 studies; n = 683), processing affective versus neutral material during WM tasks was associated with more frequent recruitment of the vlPFC, the amygdala, and the temporo-occipital cortex. In contrast to healthy individuals, across behavioral studies those suffering from mental health problems (n = 2,041) showed impaired WM accuracy (d̂ = -0.21) in the presence of affective material. These findings highlight the importance of integrating behavioral and neural levels of analysis. Finally, these findings suggest that affective WM capacity may be a transdiagnostic mechanism associated with poor mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Factor analyses differentiate clinical phenotypes of idiopathic and interferon-alpha-induced depression.

The discovery that prolonged administration of interferon-alpha (a pro-inflammatory cytokine) readily precipitates depressive symptoms has played a key role in development of the inflammation theory of major depressive disorder (MDD). However, it remains unclear whether the clinical phenotype of patients with inflammation-associated depression significantly overlaps with, or can be distinguished from that of patients with 'idiopathic' depression. Here we explored the Hamilton depression scale factor structure of 172 patients undergoing interferon-alpha treatment for hepatitis-C at the point of transition to a depressive episode of DSM IV defined major depression severity. The resulting factor structure was first compared with a model derived from 6 previous studies of 'idiopathic' MDD (Cole et al., 2004). This confirmatory factor analysis revealed that the factor structure of HAMD scores in our interferon-alpha treated cohort did not plausibly fit that previously described for 'idiopathic' MDD. Instead, subsequent exploratory factor analysis revealed a distinct four factor model with a novel primary factor grouping cognitive symptoms of depression and anxiety (HAMD items 1, 2, 9, 10, 11, 15). The second sleep disorder factor (items 4, 5, 6) replicated previous findings in 'idiopathic' depression. A third and unique factor grouped somatic symptoms and function (items 7, 12, 13, 14 and item 1). The final factor (also common in idiopathic depression studies), grouped gastrointestinal symptoms and weight loss (items 12 and 16). Severe depression items (3, 8, and 17) were excluded from analysis due to very low variance. At transition, interferon-alpha induced major depressive episodes therefore appears to have more associated anxiety features that covary with depressed mood than classical or 'idiopathic' MDD and a low likelihood of severe features such as suicidal ideation. Identification of this clinical phenotype may help identify patients with an inflammatory depression etiology and support the development of more effective and personalized therapies.

Correction to: The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital 'informed choice' intervention to improve attitudes towards uptake and implementation of CBT for psychosis.

Following publication of the original article [1], the authors reported a typing mistake in the spelling of author Iain O'Leary. The original article has been corrected.

The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital 'informed choice' intervention to improve attitudes towards uptake and implementation of CBT for psychosis.

BACKGROUND: At least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment. Cognitive behaviour therapy for psychosis (CBTp) is the only NICE-recommended individual therapy for psychosis, with effects on symptoms, distress and quality of life. Yet <10% of service-users receive it and 94% of trusts struggle to provide it. Of those offered it, 22-43% refuse or do not attend. We have developed a new pre-CBTp informed choice intervention to address knowledge and attitudes that influence uptake and implementation and now want to test it in a feasibility trial. METHODS: The design is a two-arm, feasibility randomised controlled trial (RCT), with 1:1 randomisation, stratified by participant group and site. Participants are 40 psychosis patients and 40 clinicians, who are ambivalent towards uptake or implementation of CBTp. Sites are community and inpatient services in Sussex and London. The intervention is a pre-CBT digital psychoeducation intervention designed to address identified knowledge and attitudinal barriers to uptake and implementation of CBTp, incorporating behaviour change mechanisms, and supported by animated introductory, patient and clinician stories. The comparator is the NHS choices website for CBT. The primary aim is to assess clinical feasibility (recruitment, randomisation, acceptability, use, delivery, outcome measurement, retention). A secondary aim is a preliminary evaluation of efficacy. Outcomes will be assessed at baseline, post intervention, and one-month follow-up (blind to treatment arm). The primary efficacy outcome is likelihood of offering/taking up CBTp. Secondary outcomes include knowledge and attitudes towards CBTp, illness perceptions, empowerment, psychological wellbeing (patients only) and CBTp implementation (clinicians only). Use of the intervention and CBT behaviours during the follow-up period will be recorded and captured in a feedback questionnaire. Use, acceptability and experience of outcome assessment will be explored in qualitative interviews with participants (n = 6 per group). The efficacy evaluation will report descriptive data, key model parameters and 95% highest probability density intervals in a Bayesian growth model. DISCUSSION: This is the first feasibility trial of a digital 'informed choice' decision aid for the implementation of CBTp. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted. TRIAL REGISTRATION: ISRCTN registry, ISRCTN53107879 . Registered prospectively on 2 August 2017.