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): DERR1-10.2196/2746

A hybrid ecological momentary compassion-focused intervention for enhancing resilience in help-seeking young people:A prospective study of baseline characteristics in the EMIcompass trial

BACKGROUND: Young people are a target population for mental health–related early intervention and prevention. Although evidence for early intervention is promising, availability of and access to youth mental health services remain limited. Therefore, the development of an evidence-based hybrid intervention is urgently needed. OBJECTIVE: This study aimed to present a manual for a hybrid intervention, combining an ecological momentary intervention and face-to-face sessions aimed for enhancing resilience in help-seeking young people based on compassion-focused interventions, and explore whether participants’ baseline characteristics are associated with putative mechanisms and outcomes of the EMIcompass intervention. Specifically, we aimed to explore initial signals as to whether participants’ sociodemographic, clinical, and functional characteristics at baseline are associated with putative mechanisms (ie, change in self-compassion, change in emotion regulation, working alliance, training frequency); and whether participants’ sociodemographic, clinical, and functional characteristics, self-compassion, and emotion regulation at baseline are associated with clinical outcomes (ie, psychological distress and general psychopathology at postintervention and 4-week follow-ups) in the experimental condition and obtain first parameter estimates. METHODS: We recruited young people aged 14 to 25 years, with psychological distress, Clinical High At-Risk Mental State, or first episodes of severe mental disorder for an exploratory randomized controlled trial with assessments at baseline and postintervention and 4-week follow-ups. A structured manual was developed and optimized based on a pilot study’s manual, a scoping review of existing literature and manuals, exchange with experts, the team’s clinical experience of working with compassion-focused interventions, and the principles of ecological momentary interventions. This analysis focuses on the experimental condition receiving the EMIcompass intervention. RESULTS: A total of 46 young individuals were randomized to the experimental condition. There was evidence for initial signals of effects of age (B=0.11, 95% CI 0.00-0.22), general psychopathology (B=0.08, 95% CI −0.01 to 0.16), and clinical stage (B=1.50, 95% CI 0.06-2.93) on change in momentary self-compassion and change in emotion regulation from baseline to postintervention assessments. There was no evidence for associations of other baseline characteristics (eg, gender, minority status, and level of functioning) and putative mechanisms (eg, overall self-compassion, working alliance, and training frequency). In addition, except for an initial signal for an association of momentary self-compassion at baseline and psychological distress (B=−2.83, 95% CI −5.66 to 0.00), we found no evidence that baseline characteristics related to clinical outcomes. CONCLUSIONS: The findings indicated the reach of participants by the intervention largely independent of sociodemographic, clinical, and functional baseline characteristics. The findings need to be confirmed in a definitive trial. TRIAL REGISTRATION: German Clinical Trials Register NDRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/2746

omega-3 fatty acids contribute to the asthma-protective effect of unprocessed cow's milk

Background: Living on a farm has repeatedly been shown to protect children from asthma and allergies. A major factor involved in this effect is consumption of unprocessed cow's milk obtained directly from a farm. However, this phenomenon has never been shown in a longitudinal design, and the responsible milk components are still unknown. Objectives: We sought to assess the asthma-protective effect of unprocessed cow's milk consumption in a birth cohort and to determine whether the differences in the fatty acid (FA) composition of unprocessed farm milk and industrially processed milk contributed to this effect. Methods: The Protection Against Allergy-Study in Rural Environments (PASTURE) study followed 1133 children living in rural areas in 5 European countries from birth to age 6 years. In 934 children milk consumption was assessed by using yearly questionnaires, and samples of the ``usually'' consumed milk and serum samples of the children were collected at age 4 years. Doctor-diagnosed asthma was parent reported at age 6 years. In a nested case-control study of 35 asthmatic and 49 nonasthmatic children, 42 FAs were quantified in milk samples. Results: The risk of asthma at 6 years of age was reduced by previous consumption of unprocessed farm milk compared with shop milk (adjusted odds ratio for consumption at 4 years, 0.26; 95% CI,0.10-0.67). Part of the effect was explained by the higher fat content of farm milk, particularly the higher levels of omega-3 polyunsaturated FAs (adjusted odds ratio, 0.29; 95% CI,0.11-0.81). Conclusion: Continuous farm milk consumption in childhood protects against asthma at school age partially by means of higher intake of omega-3 polyunsaturated FAs, which are precursors of anti-inflammatory mediators.Peer reviewe

A survey-based assessment of attitudes and needs regarding tinnitus healthcare among patients and healthcare professionals in Europe

Despite good agreement of national guidelines for the assessment and treatment of tinnitus, there is still substantial variation regarding tinnitus-related healthcare across Europe. In contrast to previous work, which has mainly focussed on the perspective of healthcare professionals, we here report the results of separate web-based surveys conducted with clinicians and researchers as well as tinnitus patients. These surveys were devised to obtain information about their respective attitudes and needs with respect to tinnitus healthcare, and to reveal possible interdisciplinary inconsistencies among clinicians and researchers. We mainly targeted participants from Germany, Cyprus, and Greece, the countries in which the institutions of the researchers involved in this project are based. Results showed, firstly, that the treatment satisfaction of the patients was overall more negative than that of the clinicians and researchers, and that the patients' treatment satisfaction did not depend on the number of different treatments they had received. Secondly, patients as well as clinicians and researchers indicated that they were interested in learning more about a variety of tinnitus-related topics, especially treatment strategies, with no marked differences between clinicians from different professional disciplines. This suggests similar tinnitus-specific educational needs in patients and healthcare professionals

A compassion-focused ecological momentary intervention for enhancing resilience in help-seeking youth:Uncontrolled pilot study

BACKGROUND: Digital interventions offer new avenues for low-threshold prevention and treatment in young people. Ecological momentary interventions (EMIs) represent a powerful approach that allows for adaptive, real-time, and real-world delivery of intervention components in daily life by real-time processing of ecological momentary assessment (EMA) data. Compassion-focused interventions (CFIs) may be particularly amenable to translation into an EMI to strengthen emotional resilience and modify putative risk mechanisms, such as stress sensitivity, in the daily lives of young help-seeking individuals. OBJECTIVE: This study aims to investigate the feasibility, safety, and initial therapeutic effects of a novel, accessible, transdiagnostic, ecological momentary CFI for improving emotional resilience to stress (EMIcompass). METHODS: In this uncontrolled pilot study, help-seeking youth with psychotic, depressive, or anxiety symptoms were offered the EMIcompass intervention in addition to treatment as usual. The EMIcompass intervention consisted of a 3-week EMI (including enhancing, consolidating, and EMA-informed interactive tasks) administered through a mobile health app and three face-to-face sessions with a trained psychologist intended to provide guidance and training on the CFI exercises presented in the app (ie, training session, follow-up booster session, and review session). RESULTS: In total, 10 individuals (mean age 20.3 years, SD 3.8; range 14-25) were included in the study. Most (8/10, 80%) participants were satisfied and reported a low burden of app usage. No adverse events were observed. In approximately one-third of all EMAs, individuals scored high on stress, negative affect, or threat anticipation during the intervention period, resulting in real-time, interactive delivery of the CFI intervention components in addition to weekly enhancing and daily consolidating tasks. Although the findings should be interpreted with caution because of the small sample size, reduced stress sensitivity, momentary negative affect, and psychotic experiences, along with increased positive affect, were found at postintervention and the 4-week follow-up. Furthermore, reductions in psychotic, anxiety, and depressive symptoms were found (r=0.30-0.65). CONCLUSIONS: Our findings provide evidence on the feasibility and safety of the EMIcompass intervention for help-seeking youth and lend initial support to beneficial effects on stress sensitivity and mental health outcomes. An exploratory randomized controlled trial is warranted to establish the feasibility and preliminary evidence of its efficacy

A control theoretic approach to evaluate and inform ecological momentary interventions

Ecological momentary interventions (EMI) are digital mobile health (mHealth) interventions that are administered in an individual's daily life with the intent to improve mental health outcomes by tailoring intervention components to person, moment, and context. Questions regarding which intervention is most effective in a given individual, when it is best delivered, and what mechanisms of change underlie observed effects therefore naturally arise in this setting. To achieve this, EMI are typically informed by the collection of multivariate, intensive longitudinal data of various target constructs - designed to assess an individual’s psychological state - using ecological momentary assessments (EMA). However, the dynamic and interconnected nature of such multivariate time series data poses several challenges when analyzing and interpreting findings. This may be illustrated when understanding psychological variables as part of an interconnected network of dynamic variables, and the delivery of EMI as time-specific perturbations to these variables. Network control theory (NCT) is a branch of dynamical systems theory that precisely deals with the formal analysis of such network perturbations and provides solutions of how to perturb a network to reach a desired state in an optimal manner. In doing so, NCT may help to formally quantify and evaluate proximal intervention effects, as well as to identify optimal intervention approaches given a set of reasonable (temporal or energetic) constraints. In this proof-of-concept study, we leverage concepts from NCT to analyze the data of 10 individuals undergoing joint EMA and EMI for several weeks. We show how simple metrics derived from NCT can provide insightful information on putative mechanisms of change in the inferred EMA networks and contribute to identifying optimal leveraging points. We also outline what additional considerations might play a role in the design of effective intervention strategies in the future from the perspective of NCT

An ecological momentary compassion-focused intervention for enhancing resilience in help-seeking youths: a pilot study

Digital interventions offer new avenues for prevention and treatment in youth. Ecological momentary interventions (EMIs) allow for adaptive and real-time delivery of intervention components in daily life. Compassion-focused interventions may be particularly amenable to translation into an EMI to strengthen emotional resilience in youth. We aimed to investigate initial therapeutic effects, feasibility, and safety of a novel, accessible, transdiagnostic, ecological momentary, compassion-focused intervention for improving emotional resilience (‘EMIcompass’) in an uncontrolled pilot study including help-seeking youth with psychotic, depressive, and/or anxiety symptoms. The EMIcompass intervention consisted of three sessions with a trained psychologist and a 3-week EMI administered through a mobile health app. In total, ten individuals (Mage=20.3 years) were included. Reduced stress sensitivity, momentary negative affect, and psychotic experiences as well as increased positive affect were found at post-intervention and 4-week follow-up. Further, reductions in psychotic, anxiety, and depressive symptoms of medium to large effect size were found (r=0.30-0.65). Most participants were satisfied (80%) and reported low burden of app usage. No adverse events were observed. Our findings provide initial evidence on beneficial effects, feasibility, and safety of the EMIcompass intervention in help-seeking youth. An exploratory randomised controlled trial is warranted to establish feasibility and preliminary evidence of efficacy

Dimensions of Tinnitus-Related Distress

Objectives: (1) To determine which psychosocial aspects predict tinnitus-related distress in a large self-reported dataset of patients with chronic tinnitus, and (2) to identify underlying constructs by means of factor analysis. Methods: A cohort of 1958 patients of the Charité Tinnitus Center, Berlin completed a large questionnaire battery that comprised sociodemographic data, tinnitus-related distress, general psychological stress experience, emotional symptoms, and somatic complaints. To identify a construct of “tinnitus-related distress”, significant predictive items were grouped using factor analysis. Results: For the prediction of tinnitus-related distress (linear regression model with R2 = 0.7), depressive fatigue symptoms (concentration, sleep, rumination, joy decreased), the experience of emotional strain, somatization tendencies (pain experience, doctor contacts), and age appeared to play a role. The factor analysis revealed five factors: “stress”, “pain experience”, “fatigue”, “autonomy”, and low “educational level”. Conclusions: Tinnitus-related distress is predicted by psychological and sociodemographic indices. Relevant factors seem to be depressive exhaustion with somatic expressions such as sleep and concentration problems, somatization, general psychological stress, and reduced activity, in addition to higher age

The effects of a novel, transdiagnostic, hybrid ecological momentary intervention for improving resilience in youth (EMIcompass): study 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 later in life and for improving resilience. Compassion-focused interventions (CFIs) offer a wide range of innovative therapeutic techniques particularly amenable to being implemented as Ecological Momentary Interventions (EMIs), a specific type of mHealth intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge a gap in current youth mental health care. Objectives: The aim of this study will be to investigate the clinical feasibility, candidate underlying mechanisms and initial signals of efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth (EMIcompass). Methods: In an exploratory randomized controlled trial (RCT), youth aged 14-25 with current distress, a broad Clinical High At-Risk Mental State (CHARMS) or a first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (EMI plus face-to-face training sessions) in addition to treatment as usual (TAU) or a control condition of TAU only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, momentary physiological markers of stress reactivity) as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms, general psychopathology) will be assessed at baseline, post-intervention and 4-week follow-up. Results: The first enrolment was in August 2019 and as of May 2021, enrolment and randomization has been completed (n = 92 participants). We expect the end of data collection in August 2021. Conclusions: The current study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of efficacy of a compassion-focused EMI in youth. If successful, a confirmatory RCT 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 (DRKS), DRKS00017265; Date of registration: 31.07.2019

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