The LEADING Guideline: Reporting Standards for Expert Panel, Best-Estimate Diagnosis, and Longitudinal Expert All Data (LEAD) Studies.

Accurate assessments of symptoms and diagnoses are essential for health research and clinical practice but face many challenges. The absence of a single error-free measure is currently addressed by assessment methods involving experts reviewing several sources of information to achieve a more accurate or best-estimate assessment. Three bodies of work spanning medicine, psychiatry, and psychology propose similar assessment methods: The Expert Panel, the Best-Estimate Diagnosis, and the Longitudinal Expert All Data (LEAD). However, the quality of such best-estimate assessments is typically very difficult to evaluate due to poor reporting of the assessment methods and when it is reported, the reporting quality varies substantially. Here we tackle this gap by developing reporting guidelines for such studies, using a four-stage approach: 1) drafting reporting standards accompanied by rationales and empirical evidence, which were further developed with a patient organization for depression, 2) incorporating expert feedback through a two-round Delphi procedure, 3) refining the guideline based on an expert consensus meeting, and 4) testing the guideline by i) having two researchers test it and ii) using it to examine the extent previously published articles report the standards. The last step also demonstrates the need for the guideline: 18 to 58% (Mean = 33%) of the standards were not reported across fifteen randomly selected studies. The LEADING guideline comprises 20 reporting standards related to four groups: The Longitudinal design; the Appropriate data; the Evaluation - experts, materials, and procedures; and the Validity group. We hope that the LEADING guideline will be useful in assisting researchers in planning, reporting, and evaluating research aiming to achieve best-estimate assessments.

An interpretative phenomenological analysis of the lived experience of people with multimorbidity in low- and middle-income countries.

People living with multimorbidity (PLWMM) have multiple needs and require long-term personalised care, which necessitates an integrated people-centred approach to healthcare. However, people-centred care may risk being a buzzword in global health and cannot be achieved unless we consider and prioritise the lived experience of the people themselves. This study captures the lived experiences of PLWMM in low- and middle-income countries (LMICs) by exploring their perspectives, experiences, and aspirations.We analysed 50 semi-structured interview responses from 10 LMICs across three regions-South Asia, Latin America, and Western Africa-using an interpretative phenomenological analysis approach.The bodily, social, and system experiences of illness by respondents were multidirectional and interactive, and largely captured the complexity of living with multimorbidity. Despite expensive treatments, many experienced little improvements in their conditions and felt that healthcare was not tailored to their needs. Disease management involved multiple and fragmented healthcare providers with lack of guidance, resulting in repetitive procedures, loss of time, confusion, and frustration. Financial burden was exacerbated by lost productivity and extreme finance coping strategies, creating a vicious cycle. Against the backdrop of uncertainty and disruption due to illness, many demonstrated an ability to cope with their conditions and navigate the healthcare system. Respondents' priorities were reflective of their desire to return to a pre-illness way of life-resuming work, caring for family, and maintaining a sense of independence and normalcy despite illness. Respondents had a wide range of needs that required financial, health education, integrated care, and mental health support.In discussion with respondents on outcomes, it appeared that many have complementary views about what is important and relevant, which may differ from the outcomes established by clinicians and researchers. This knowledge needs to complement and be incorporated into existing research and treatment models to ensure healthcare remains focused on the human and our evolving needs.

Transdiagnostic Ecological Momentary Intervention for Improving Self-Esteem in Youth Exposed to Childhood Adversity: The SELFIE Randomized Clinical Trial.

Importance: Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorders. Ecological momentary interventions (EMIs) allow for the delivery of youth-friendly, adaptive interventions for improving self-esteem, but robust trial-based evidence is pending. Objective: To examine the efficacy of SELFIE, a novel transdiagnostic, blended EMI for improving self-esteem plus care as usual (CAU) compared with CAU only. Design, Setting, and Participants: This was a 2-arm, parallel-group, assessor-blinded, randomized clinical trial conducted from December 2018 to December 2022. The study took place at Dutch secondary mental health services and within the general population and included youth (aged 12-26 years) with low self-esteem (Rosenberg Self-Esteem Scale [RSES] <26) exposed to childhood adversity. Interventions: A novel blended EMI (3 face-to-face sessions, email contacts, app-based, adaptive EMI) plus CAU or CAU only. Main Outcomes and Measures: The primary outcome was RSES self-esteem at postintervention and 6-month follow-up. Secondary outcomes included positive and negative self-esteem, schematic self-beliefs, momentary self-esteem and affect, general psychopathology, quality of life, observer-rated symptoms, and functioning. Results: A total of 174 participants (mean [SD] age, 20.7 [3.1] years; 154 female [89%]) were included in the intention-to-treat sample, who were primarily exposed to childhood emotional abuse or neglect, verbal or indirect bullying, and/or parental conflict. At postintervention, 153 participants (87.9%) and, at follow-up, 140 participants (80.5%), provided primary outcome data. RSES self-esteem was, on average, higher in the experimental condition (blended EMI + CAU) than in the control condition (CAU) across both postintervention and follow-up as a primary outcome (B = 2.32; 95% CI, 1.14-3.50; P < .001; Cohen d-type effect size [hereafter, Cohen d] = 0.54). Small to moderate effect sizes were observed suggestive of beneficial effects on positive (B = 3.85; 95% CI, 1.83-5.88; P < .001; Cohen d = 0.53) and negative (B = -3.78; 95% CI, -6.59 to -0.98; P = .008; Cohen d = -0.38) self-esteem, positive (B = 1.58; 95% CI, 0.41-2.75; P = .008; Cohen d = 0.38) and negative (B = -1.71; 95% CI, -2.93 to -0.48; P = .006; Cohen d = -0.39) schematic self-beliefs, momentary self-esteem (B = 0.29; 95% CI, 0.01-0.57; P = .04; Cohen d = 0.24), momentary positive affect (B = 0.23; 95% CI, 0.01-0.45; P = .04; Cohen d = 0.20), momentary negative affect (B = -0.33; 95% CI, -0.59 to -0.03, P = .01, Cohen d = -0.27), general psychopathology (B = -17.62; 95% CI, -33.03 to -2.21; P = .03; Cohen d = -0.34), and quality of life (B = 1.16; 95% CI, 0.18-2.13; P = .02; Cohen d = 0.33) across postintervention and follow-up. No beneficial effects on symptoms and functioning were observed. Conclusions and Relevance: A transdiagnostic, blended EMI demonstrated efficacy on the primary outcome of self-esteem and signaled beneficial effects on several secondary outcomes. Further work should focus on implementing this novel EMI in routine public mental health provision. Trial Registration: Dutch Trial Register Identifier:NL7129(NTR7475).

Risk factors associated with overweight and obesity in people with severe mental illness in South Asia: cross-sectional study in Bangladesh, India, and Pakistan.

Obesity is one of the major contributors to the excess mortality seen in people with severe mental illness (SMI) and in low- and middle-income countries people with SMI may be at an even greater risk. In this study, we aimed to determine the prevalence of obesity and overweight in people with SMI and investigate the association of obesity and overweight with sociodemographic variables, other physical comorbidities, and health-risk behaviours. This was a multi-country cross-sectional survey study where data were collected from 3989 adults with SMI from three specialist mental health institutions in Bangladesh, India, and Pakistan. The prevalence of overweight and obesity was estimated using Asian BMI thresholds. Multinomial regression models were then used to explore associations between overweight and obesity with various potential determinants. There was a high prevalence of overweight (17·3 %) and obesity (46·2 %). The relative risk of having obesity (compared to normal weight) was double in women (RRR = 2·04) compared with men. Participants who met the WHO recommendations for fruit and vegetable intake had 2·53 (95 % CI: 1·65-3·88) times greater risk of having obesity compared to those not meeting them. Also, the relative risk of having obesity in people with hypertension is 69 % higher than in people without hypertension (RRR = 1·69). In conclusion, obesity is highly prevalent in SMI and associated with chronic disease. The complex relationship between diet and risk of obesity was also highlighted. People with SMI and obesity could benefit from screening for non-communicable diseases, better nutritional education, and context-appropriate lifestyle interventions.

Examining the impact of a universal social and emotional learning intervention (Passport) on internalising symptoms and other outcomes among children, compared to the usual school curriculum: study protocol for a school-based cluster randomised trial.

BACKGROUND: School-based universal social and emotional learning (SEL) interventions implemented during the transition to adolescence may be efficacious in preventing the development of mental health difficulties. This protocol describes a two-arm parallel cluster randomised controlled trial to investigate the impact of a universal SEL intervention (Passport, compared to usual provision) on internalising symptoms (primary outcome), emotion regulation, well-being, loneliness, social support, bullying, academic attainment, and health-related quality of life in English primary school pupils aged 9-11 years. A developer-led trial demonstrated the feasibility, acceptability, and utility of Passport; this will be the first independent trial. METHODS: Sixty primary schools will be recruited across the Greater Manchester city region and surrounding areas, involving 2400 pupils aged 8-9 at baseline. Schools will be allocated to the intervention arm to implement Passport over 18 weekly sessions or to the control arm to implement the usual school curriculum. Random allocation will be at school level following completion of baseline measures, with minimisation to ensure balance across trial arms in school size and free school meal eligibility. Measures will be collected at baseline, post-intervention (12 months post-baseline), and at 12 months follow-up (24 months post-baseline). The primary outcome analysis (intervention effects on internalising symptoms at post-intervention) will comprise a two-level (school, child) hierarchical linear model, following the intention-to-treat principle. Additional analyses will be undertaken to assess intervention effects on secondary outcomes, maintenance effects for all outcomes, intervention compliance moderator effects, subgroup moderator effects, and mechanisms underpinning intervention effects on the primary outcome. A mixed-methods implementation and process evaluation will examine factors that influence implementation, and a health economic evaluation will assess the cost-effectiveness of the intervention. DISCUSSION: Findings will provide educators with crucial knowledge of whether and how increasing emotion regulation through a universal intervention impacts internalising symptoms and a range of related outcomes. Findings will also inform policy related to the promotion of mental health among children and young people. If the intervention is found to be efficacious in reducing internalising symptoms and is also cost-effective, it may offer high potential as a preventative intervention for widespread implementation. TRIAL REGISTRATION: ISRCTN12875599; registered on 24 November 2022.

Exploring putative therapeutic mechanisms of change in a hybrid compassion-focused, ecological momentary intervention: Findings from the EMIcompass trial.

Compassion-focused interventions represent a promising transdiagnostic approach, but the mechanisms involved in hybrid delivery combining face-to-face sessions and an ecological momentary intervention remain unexplored. The current study aimed at exploring associations of putative mechanisms with clinical outcomes at post-intervention/follow-up and mediation of outcome at follow-up by preceding pre-to post-intervention changes in putative mechanisms. The compassion-focused EMIcompass intervention was applied in an exploratory randomized controlled trial (treatment as usual (TAU) vs. TAU + EMIcompass) with youth with early mental health problems. Data was collected before randomization, at post-intervention and at four-week follow-up. We recruited N = 92 participants, N = 46 were allocated to the experimental condition. After control for baseline levels of the target outcomes, baseline-to post-intervention improvement in adaptive emotion regulation was associated with lower levels of clinical outcomes (e.g. psychological distress b = -1.15; 95%CI = -1.92 to -0.39) across time points. We could not detect indirect effects, but we observed associations of change in self-compassion and adaptive emotion regulation with outcomes at follow-up in the mediation analysis (e.g., ß = -0.35, 95%CI = -0.52 to -0.16). If successfully targeted by interventions, self-compassion and emotion regulation may be promising putative therapeutic mechanisms of change.

Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.

BACKGROUND/HYPOTHESIS: Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems. STUDY DESIGN: In an exploratory, assessor-blind randomized controlled trial, youth aged 14-25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+treatment as usual [TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary outcomes were collected. STUDY RESULTS: Criteria for the feasibility of trial methodology and intervention delivery were met (n = 92 randomized participants). No serious adverse events were observed. Initial outcome signals were evident for reduced momentary stress reactivity (stress×time×condition, B = -0.10 95%CI -0.16--0.03, d = -0.10), aberrant salience (condition, B = -0.38, 95%CI -0.57--0.18, d = -0.56) as well as enhanced momentary resilience (condition, B = 0.55, 95%CI 0.18-0.92, d = 0.33) and quality of life (condition, B = 0.82, 95%CI 0.10-1.55, d = 0.60) across post-intervention and 4-week follow-up. No outcome signals were observed for self-reported psychological distress (condition, B = 0.57, 95%CI -1.59-2.72, d = 0.09), but there was suggestive evidence of reduced observer-rated symptoms at the 4-week follow-up (B = -1.41, 95%CI -2.85-0.02, d = -0.41). CONCLUSIONS: Our findings provide evidence of feasibility and initial signals that EMIcompass may reduce stress reactivity and improve quality of life. A definitive trial is now warranted.

Prevalence of physical health conditions and health risk behaviours in people with severe mental illness in South Asia: multi-country cross-sectional survey.

BACKGROUND: People with severe mental illness (SMI) die earlier than the general population, primarily because of physical disorders. AIMS: We estimated the prevalence of physical health conditions, health risk behaviours, access to healthcare and health risk modification advice in people with SMI in Bangladesh, India and Pakistan, and compared results with the general population. METHOD: We conducted a cross-sectional survey in adults with SMI attending mental hospitals in Bangladesh, India and Pakistan. Data were collected on non-communicable diseases, their risk factors, health risk behaviours, treatments, health risk modification advice, common mental disorders, health-related quality of life and infectious diseases. We performed a descriptive analysis and compared our findings with the general population in the World Health Organization (WHO) 'STEPwise Approach to Surveillance of NCDs' reports. RESULTS: We recruited 3989 participants with SMI, of which 11% had diabetes, 23.3% had hypertension or high blood pressure and 46.3% had overweight or obesity. We found that 70.8% of participants with diabetes, high blood pressure and hypercholesterolemia were previously undiagnosed; of those diagnosed, only around half were receiving treatment. A total of 47% of men and 14% of women used tobacco; 45.6% and 89.1% of participants did not meet WHO recommendations for physical activity and fruit and vegetable intake, respectively. Compared with the general population, people with SMI were more likely to have diabetes, hypercholesterolemia and overweight or obesity, and less likely to receive tobacco cessation and weight management advice. CONCLUSIONS: We found significant gaps in detection, prevention and treatment of non-communicable diseases and their risk factors in people with SMI.

Negative effects during multicomponent group-based treatment: A multisite study.

Objective Negative effects (NEs) in group treatments remain an under-researched area. This study aimed to explore the prevalence of various types of NEs in a multicomponent group-based treatment and to determine their predictors. Method: A total of 330 patients participating in a multicomponent group-based treatment were recruited across seven clinical sites. At the end of treatment, the Negative Effects Questionnaire (NEQ) was used to measure NEs. Item-level descriptive analysis was conducted to explore the prevalence of various types of NEs, and structural equation modeling was used to determine predictors of these NEs. Results: The most frequently reported type of NEs was the worsening of symptoms, and the single most frequently reported item was the resurfacing of unpleasant memories. Predictors of NEs included the overall distress level, alexithymia, attachment avoidance, low working alliance, problem actuation, and worse outcomes; psychological mindedness was a protective factor. Conclusion: Patients who experience higher levels of distress at the beginning of treatment, who perceive the group working alliance as problematic, and who experience high in-session emotional arousal related to their problem seem to be especially prone to reporting NEs. Furthermore, the findings do not support the assumption that NEs are a prerequisite for therapeutic change.Trial registration: ISRCTN.org identifier: ISRCTN13532466.

Heterogeneous attitudinal profiles towards gene editing: Evidence from latent class analysis.

Advances in gene-editing technology have important implications for the treatment and prevention of disease. Accordingly, it is important to understand public perceptions towards gene editing, as the public's willingness to endorse gene editing may be as important as technological breakthroughs themselves. Previous research has almost exclusively examined attitudes towards gene editing on specific issues, but has not addressed how attitudes towards gene editing across a range of issues coalesce in individuals: that is, the degree to which discrete, heterogeneous attitudinal profiles exist versus a simple support/oppose continuum. Here, we addressed this issue using latent class analysis on data from The Pew Research Center (N = 4726; US residents) across a wide range of gene-editing topics. We found that attitudes towards gene editing cohere into 10 distinct latent classes that showed some evidence of a support/oppose continuum, but also for clear qualitative differences between each class, even with support or oppose classes, on a number of issues. The most opposed classes significantly differed from the supporter classes in age, sex, political ideology and self-rated knowledge. These findings provide evidence that attitudes towards gene editing are heterogeneous and public discourse, as well as policy making need to consider a range of arguments when evaluating this technology.

The impact of the COVID-19 pandemic on adolescent mental health: a natural experiment.

Despite widespread concern about the impact of COVID-19 on adolescent mental health, there remains limited empirical evidence that can causally attribute changes to the pandemic. The current study aimed to overcome existing methodological limitations by exploiting a serendipitously occurring natural experiment within two ongoing, multi-phase cluster randomized controlled trials. Depressive symptoms (primary outcome), externalizing difficulties and life satisfaction (secondary outcomes) were assessed at baseline (phase 1 [pre-COVID-19 group]: September - October 2018, phase 2 [COVID-19 group]: September - October 2019) and 1-year follow-up (pre-COVID-19 group: January - March 2020, COVID-19 group: February - April 2021). Participants in phase 1 (N = 6419) acted as controls. In phase 2, participants (N = 5031) were exposed to the COVID-19 pandemic between the baseline and follow-up assessments providing a natural experimental design. The primary analysis used a random intercept linear multivariable regression model with phase (exposure to the COVID-19 pandemic) included as the key predictor while controlling for baseline scores and individual and school-level covariates. Depressive symptoms were higher and life satisfaction scores lower in the group exposed to the COVID-19 pandemic. Had the COVID-19 pandemic not occurred, we estimate that there would be 6% fewer adolescents with high depressive symptoms. No effect of exposure to the pandemic on externalizing difficulties was found. Exploratory analyses to examine subgroup differences in impacts suggest that the negative impact of the COVID-19 pandemic on adolescent mental health may have been greater for females than males. Given the widespread concern over rising adolescent mental health difficulties prior to the pandemic, this paper quantifies the additional impacts of the pandemic. A properly resourced, multi-level, multi-sector public health approach for improving adolescent mental health is necessary. Following in-principle acceptance, the approved Stage 1 version of this manuscript was preregistered on the OSF at https://doi.org/10.17605/OSF.IO/B25DH. This preregistration was performed prior to data analysis.

Mechanisms of change in multicomponent group-based treatment for patients suffering from medically unexplained physical symptoms.

Understanding psychological mechanisms of change is essential to advance treatments for patients suffering from medically unexplained physical symptoms (MUPS). This study aimed to test the role of selected change mechanisms (incl. interoceptive awareness, emotional regulation skills, symptom acceptance, relational needs satisfaction, clarification of meaning, working alliance, and group cohesion) in the modification of patients' somatic symptom intensity and well-being.N = 290 patients suffering from MUPS participated in a multi-component group-based treatment at seven clinical sites. Data were collected weekly. Multi-level modeling was used to test cross-lagged relationships between the hypothesized mechanisms and outcomes in terms of Granger causality (with lags of 1, 2, and 3 weeks).None of the mechanisms predicted a time-lagged change in outcomes in the expected direction. In fact, there was a consistent pattern of negative time-lagged relationships (i.e., an increase in a mechanism predicted worsening of the outcome). Findings consistent with the hypothesized role of the mechanisms were found only in concurrent relationships between mechanisms and outcomes.This study did not support time-lagged relationships under the condition of weekly measurement and many methodological factors remain to be considered (e.g., a finer time resolution).

Common measures or common metrics? A plea to harmonize measurement results.

OBJECTIVE: There is a great variety of measurement instruments to assess similar constructs in clinical research and practice. This complicates the interpretation of test results and hampers the implementation of measurement-based care. METHOD: For reporting and discussing test results with patients, we suggest converting test results into universally applicable common metrics. Two well-established metrics are reviewed: T scores and percentile ranks. Their calculation is explained, their merits and drawbacks are discussed, and recommendations for the most convenient reference group are provided. RESULTS: We propose to express test results as T scores with the general population as reference group. To elucidate test results to patients, T scores may be supplemented with percentile ranks, based on data from a clinical sample. The practical benefits are demonstrated using the published data of four frequently used instruments for measuring depression: the CES-D, PHQ-9, BDI-II and the PROMIS depression measure. DISCUSSION: Recent initiatives have proposed to mandate a limited set of outcome measures to harmonize clinical measurement. However, the selected instruments are not without flaws and, potentially, this directive may hamper future instrument development. We recommend using common metrics as an alternative approach to harmonize test results in clinical practice, as this will facilitate the integration of measures in day-to-day practice.

Knowledge and Response to the COVID-19 Pandemic in People With Severe Mental Illness in Bangladesh and Pakistan: A Cross-Sectional Survey.

BACKGROUND: People with severe mental illnesses (SMIs) are likely to face disproportionate challenges during a pandemic. They may not receive or be able to respond to public health messages to prevent infection or to limit its spread. Additionally, they may be more severely affected, particularly in low- and middle-income countries. METHODS: We conducted a telephone survey (May-June 2020) in a sample of 1,299 people with SMI who had attended national mental health institutes in Bangladesh and Pakistan before the pandemic. We collected information on top worries, socioeconomic impact of the pandemic, knowledge of COVID-19 (symptoms, prevention), and prevention-related practices (social distancing, hygiene). We explored the predictive value of socio-demographic and health-related variables for relative levels of COVID-19 knowledge and practice using regularized logistic regression models. FINDINGS: Mass media were the major source of information about COVID-19. Finances, employment, and physical health were the most frequently mentioned concerns. Overall, participants reported good knowledge and following advice. In Bangladesh, being female and higher levels of health-related quality of life (HRQoL) predicted poor and better knowledge, respectively, while in Pakistan being female predicted better knowledge. Receiving information from television predicted better knowledge in both countries. In Bangladesh, being female, accessing information from multiple media sources, and better HRQoL predicted better practice. In Pakistan, poorer knowledge of COVID-19 prevention measures predicted poorer practice. CONCLUSION: Our paper adds to the literature on people living with SMIs and their knowledge and practices relevant to COVID-19 prevention. Our results emphasize the importance of access to mass and social media for the dissemination of advice and that the likely gendered uptake of both knowledge and practice requires further attention.

Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol.

INTRODUCTION: 'Multimorbidity' describes the presence of two or more long-term conditions, which can include communicable, non-communicable diseases, and mental disorders. The rising global burden from multimorbidity is well documented, but trial evidence for effective interventions in low-/middle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental to trial design to ensure cross-study comparability, but there is currently no agreement on a core outcome set (COS) to include in trials investigating multimorbidity specifically in LMICs. Our aim is to develop international consensus on two COSs for trials of interventions to prevent and treat multimorbidity in LMIC settings. METHODS AND ANALYSIS: Following methods recommended by the Core Outcome Measures in Effectiveness Trials initiative, the development of these two COSs will occur in parallel in three stages: (1) generation of a long list of potential outcomes for inclusion; (2) two-round online Delphi surveys and (3) consensus meetings. First, to generate an initial list of outcomes, we will conduct a systematic review of multimorbidity intervention and prevention trials and interviews with people living with multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcome taxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomes from people living with multimorbidity, caregivers, healthcare professionals, policy makers and researchers in LMICs. Finally, consensus meetings including all of these stakeholders will be held to agree outcomes for inclusion in the two COSs. ETHICS AND DISSEMINATION: The study has been approved by the Research Governance Committee of the Department of Health Sciences, University of York, UK (HSRGC/2020/409/D:COSMOS). Each participating country/research group will obtain local ethics board approval. Informed consent will be obtained from all participants. We will disseminate findings through peer-reviewed open access publications, and presentations at global conferences selected to reach a wide range of LMIC stakeholders. PROSPERO REGISTATION NUMBER: CRD42020197293.

Effects of a Novel, Transdiagnostic, Hybrid Ecological Momentary Intervention for Improving Resilience in Youth (EMIcompass): Protocol for an Exploratory Randomized Controlled Trial.

BACKGROUND: Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care. OBJECTIVE: This study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth-EMIcompass. METHODS: In an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up. RESULTS: The first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021. CONCLUSIONS: This study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27462.