Digital psychosocial interventions for individuals with spinal cord injury: a scoping review.

Objective: To provide an overview of the digital mental health care landscape for individuals with spinal cord injury (SCI). Methods: PubMed, PsycInfo, and PSYNDEX were searched for articles meeting the following criteria: (1) article written in English or German; (2) digital psychosocial intervention; (3) SCI only; (4) treatment of individuals with SCI and not their relatives or caregivers. Records were screened by title and abstract and records meeting the inclusion criteria were obtained for full text screening. The references of identified articles were screened to find further relevant articles. The literature search was updated before submission. Risk of Bias was assessed by using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and a narrative synthesis was conducted. Results: Ten randomized-controlled trials (RCT) and ten non-randomized-controlled trials were identified and compared in this review, evaluating twelve internet- and mobile-based interventions, five smartphone apps, and three virtual reality applications. The interventions were primarily used as stand-alone aftercare programs. While some were not based on any theory, cognitive behavioral therapy mostly served as the theoretical basis for the online interventions. The extent of human support also varied greatly between the studies. The number of intervention modules ranged between 2 and 72. There were also major differences in outcome variables and effects. A meta-analytical evaluation of the data was not conducted due to heterogeneity of studies. Conclusion: Digital applications to promote the psychosocial health of individuals with SCI are an emerging field of research with many treatment approaches still to come. First high quality RCT studies report promising results. Unfortunately, not all studies are of high quality or the interventions have been insufficiently adapted to the needs of people with SCI. Therefore, more research is needed to further develop applications, and to generalize and test the effects found in the long term.

The multicenter effectiveness study of inpatient and day hospital treatment in departments of psychosomatic medicine and psychotherapy in Germany.

Background: Reliable outcome data of psychosomatic inpatient and day hospital treatment with a focus on psychotherapy are important to strengthen ecological validity by assessing the reality of mental health care in the field. This study aims to evaluate the effectiveness of inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy in a prospective, naturalistic, multicenter design including structured assessments. Methods: Structured interviews were used to diagnose mental disorders according to ICD-10 and DSM-IV at baseline. Depression, anxiety, somatization, eating disorder and posttraumatic stress disorder (PTSD) symptoms, as well as personality functioning were assessed by means of questionnaires on admission and at discharge. Results: 2,094 patients recruited by 19 participating university hospitals consented to participation in the study. Effect sizes for each of the outcome criteria were calculated for 4-5 sub-groups per outcome domain with differing severity at baseline. Pre-post effect sizes for patients with moderate and high symptom severity at baseline ranged from d = 0.78 to d = 3.61 with symptoms of PTSD, depression, and anxiety showing the largest and somatization as well as personality functioning showing somewhat smaller effects. Conclusions: Inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy is effective under field conditions. Clinical trial registration: https://drks.de/search/de/trial/DRKS00016412, identifier: DRKS00016412.

The prevalence of effort-reward imbalance and its associations with working conditions, psychosocial resources and burden among health care workers during the COVID-19 pandemic: Results of the egePan-Voice study.

OBJECTIVE: The association between a measure of effort-reward imbalance (ERI) and profession as well as gender in a sample of health care workers (HCW) during the first wave of the COVID-19 pandemic in Germany using the egePan-Voice study. In addition, we examined, which factors are associated with an effort-reward imbalance ratio (ERI ratio) >1. METHODS: In a large sample of HCW (N = 6174) we assessed occupational stress with the short version of the effort-reward imbalance (ERI) questionnaire, working conditions, COVID-19-related problems and psychosocial resources (ENRICHD Social Support Inventory, ESSI; Sense of Coherence Scale, SOC-3 and optimism, SOP2). RESULTS: The prevalence of a ERI ratio >1 among HCW was 50.9%. The prevalence's of an ERI ratio >1 were statistically significant different between gender as well as the occupational profession. The proportion of women (51.8%) with ERI ratio >1 was significantly higher than among men (47.8%). The highest ERI imbalance was found among nurses (62.8%), followed by medical technical assistants (MTA) (58.8%), while psychologists/psychotherapists revealed the lowest value (37.8%), followed by physicians (41.8%). In the total sample, most essential factors reported at this time for increased ERI ratio were: insufficient staff for the current work load, insufficient recovery, feeling insufficiently protected by measures taken by the hospital/the employer, high occupancy rate of the wards, insufficient trust in colleagues and being a nurse as compared with being a physician. CONCLUSION: The findings indicate a high proportion of HCW with effort-reward imbalance and substantial profession-related differences. Preventive interventions should be offered to vulnerable groups among the HCW to decrease the imbalance measured by work stress.

COVID-19 vaccination exacerbates ex vivo IL-6 release from isolated PBMCs.

Ex vivo culturing of isolated PBMCs from individuals vaccinated with the coronavirus disease 2019 (COVID-19) vaccine BNT162b1 revealed a pronounced T cell response in the presence of the receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. The latter was 10-fold more pronounced than the ex vivo response of PBMCs from the same individuals to other common pathogen T cell epitope pools, suggesting COVID-19 vaccination to induce RBD-specific T cell responses and not to facilitate T cell (re)activity in general. In the current study we investigated whether COVID-19 vaccination long-lastingly affects plasma interleukin (IL)-6 concentrations, complete blood counts, ex vivo IL-6 and IL-10 secretion of PBMCs cultured under basal conditions or in the presence of concanavalin (Con) A and lipopolysaccharide (LPS), salivary cortisol and α-amylase, mean arterial pressure (MAP), heart rate (HR) as well as mental and physical health status. The study was initially designed to investigate whether the presence vs. absence of own pets during urban upbringing has protective effects against psychosocial stress-induced immune activation during adulthood. However, as COVID-19 vaccines were approved while the study was ongoing and as, therefore, both vaccinated and non-vaccinated individuals have been recruited, we were able to stratify our data set with respect to the COVID-19 vaccination status and to assess the long-lasting effects of COVID-19 vaccination on physiological immunological, cardiovascular and psychosomatic health parameters. This data is presented in the current study. We show that isolated PBMCs from individuals vaccinated against COVID-19 show a ~ 600-fold increase in basal and a ~ 6000-fold increase in ConA-induced proinflammatory IL-6 secretion, and a ~ 2-fold increase in basal and ConA-induced antiinflammatory IL-10 secretion, both in comparison with non-vaccinated individuals. In contrast, LPS-induced ex vivo IL-6 and IL-10 secretions were not affected by vaccination status, as were plasma IL-6 concentrations, complete blood counts, salivary cortisol and α-amylase, cardiovascular measures and psychosomatic health. In summary, our findings are of relevance for many clinical studies ran before/during the pandemic, clearly indicating that consideration of participants' vaccination status is critical, at least when assessing ex vivo PBMC functionality.

Neutrophil-derived catecholamines mediate negative stress effects on bone.

Mental traumatization is associated with long-bone growth retardation, osteoporosis and increased fracture risk. We revealed earlier that mental trauma disturbs cartilage-to-bone transition during bone growth and repair in mice. Trauma increased tyrosine hydroxylase-expressing neutrophils in bone marrow and fracture callus. Here we show that tyrosine hydroxylase expression in the fracture hematoma of patients correlates positively with acknowledged stress, depression, and pain scores as well as individual ratings of healing-impairment and pain-perception post-fracture. Moreover, mice lacking tyrosine hydroxylase in myeloid cells are protected from chronic psychosocial stress-induced disturbance of bone growth and healing. Chondrocyte-specific ß2-adrenoceptor-deficient mice are also protected from stress-induced bone growth retardation. In summary, our preclinical data identify locally secreted catecholamines in concert with ß2-adrenoceptor signalling in chondrocytes as mediators of negative stress effects on bone growth and repair. Given our clinical data, these mechanistic insights seem to be of strong translational relevance.

What Kind of Patients Receive Inpatient and Day-Hospital Treatment in Departments of Psychosomatic Medicine and Psychotherapy in Germany?

INTRODUCTION: Germany is one of the few countries with a medical specialty of psychosomatic medicine and psychotherapy and many treatment resources of this kind. OBJECTIVE: This observational study describes the psychosomatic treatment programs as well as a large sample of day-hospital and inpatients in great detail using structured diagnostic interviews. METHODS: Mental disorders were diagnosed according to ICD-10 and DSM-IV by means of Mini-DIPS and SCID-II. In addition to the case records, a modified version of the CSSRI was employed to collect demographic data and service use. The PHQ-D was used to assess depression, anxiety, and somatization. RESULTS: 2,094 patients from 19 departments participated in the study after giving informed consent. The sample consisted of a high proportion of "complex patients" with high comorbidity of mental and somatic diseases, severe psychopathology, and considerable social and occupational dysfunction including more than 50 days of sick leave per year in half of the sample. The most frequent diagnoses were depression, somatoform and anxiety disorders, eating disorders, personality disorders, and somato-psychic conditions. CONCLUSIONS: Inpatient and day-hospital treatment in German university departments of psychosomatic medicine and psychotherapy is an intensive multimodal treatment for complex patients with high comorbidity and social as well as occupational dysfunction.

Is the Pandemic Wearing Us Out? A Cross-Sectional Study of the Prevalence of Fatigue in Adult Twins without Previous SARS-CoV-2 Infection.

During the pandemic, mental health was not only impaired in people after a SARS-CoV-2 infection, but also in people without previous infection. This is the first study on twins without prior SARS-CoV-2 infection to estimate the influence of genetic components and shared as well as individual environments on pandemic-associated fatigue. The study sample included 55 monozygotic and 45 dizygotic twin pairs. A total of 34.5% reported an increase in fatigue since the pandemic. A significant correlation was shown between the responses within monozygotic (χ2[1] = 11.14, p = 0.001) and dizygotic pairs (χ2[1] = 18.72, p < 0.001). In all pandemic-associated fatigue dimensions, individual environment (ranging from e2 = 0.64 to e2 = 0.84) and heritability (ranging from h2 = 0.32 to h2 = 1.04) seem to have the highest impact. The number of comorbidities significantly correlated with physical fatigue (Spearman's ρ = 0.232, p < 0.001) and psychological impairment due to pandemic measures with the total fatigue score (Spearman's ρ = 0.243, p < 0.001). However, calculated ANCOVAs with these significant correlations as covariates showed no significant influence on the mean values of the respective fatigue dimensions. Susceptibility to pandemic-associated fatigue may be genetically and environmentally determined, while intensity is also influenced by individual components. The prevalence of fatigue is high even in individuals without prior SARS-CoV-2 infection. Future mental health prevention and intervention programs should be implemented to alleviate the impact of the pandemic on the global population.

Genetics, shared environment, or individual experience? A cross-sectional study of the health status following SARS-CoV-2 infection in monozygotic and dizygotic twins.

Background: The clinical presentation of COVID-19 shows a remarkably broad spectrum of symptoms. Although studies with adult twins on SARS-CoV-2 infection are rare so far, the fact that there is a genetic component associated with the highly variable clinical outcomes of COVID-19 has already been highlighted in recent studies investigating potential candidate genes and polymorphisms. This is the first study of adult monozygotic (MZ) and dizygotic (DZ) twins concordantly affected by SARS-CoV-2 infection to estimate variances explained by genetic, shared, and individual environmental components of both somatic and psychological symptoms following SARS-CoV-2 infection. Materials and methods: Data were collected from 10 adult twin pairs (5 MZ, 5 DZ) in which both twins already had a SARS-CoV-2 infection. A self-designed questionnaire, the Barthel Index, and the Multidimensional Fatigue Inventory (MFI) were used to assess various symptoms and health status following SARS-CoV-2 infection. Intra-class correlations were calculated, and the Falconer formula was used to quantify and differentiate the percentages of genetic influences as well as common environment and personal experiences on the examined traits. In addition, potential factors influencing symptom burden were examined and discussed. Results: We found high estimated heritability for mental impairment after SARS-CoV-2 infection (h 2 = 1.158) and for general fatigue (h 2 = 1.258). For symptom burden, reduced activity, and reduced motivation the individual environment appears to have the strongest influence. Other fatigue symptoms are influenced by genetic effects which range between 42.8 and 69.4%. Conclusion: Both genetics and individual environment play a role in health status after SARS-CoV-2 infection-mental status could be influenced primarily by genetic make-up, whereas for symptom burden and certain fatigue dimensions, non-shared environment could play a more critical role. Possible individual factors influencing the course of the disease were identified. However, gene-environment interactions may still be a source of differences between twins, and the search for candidate genes remains crucial on the road to personalized medicine.

Heart rate variability in the prediction of mortality: A systematic review and meta-analysis of healthy and patient populations.

Measures of heart rate variability (HRV) as a predictor of risk of disease and mortality have been investigated from various perspectives for more than six decades. The aim of the present comprehensive meta-analysis is to examine eight different HRV parameters to determine their association with all-cause and cardiac mortality. A total of 32 studies and two individual participant datasets (IPD) with 37 samples and 38,008 participants were included. Lower HRV parameter values were significant predictors of higher mortality across different ages, sex, continents, populations and recording lengths. Most of the examined parameters showed comparable hazard ratios (HR). IPD sub-analysis for heart rate corrected HRV parameters confirmed the strong association between HRV and all-cause mortality. Meta-regressions revealed no effect modifier for HRs extracted from covariate-adjusted studies. Sub-analyses of studies comparing the lowest quartile of 5-min root mean square of successive differences (RMSSD) vs. the other quartiles yielded a combined HR of 1.56 (95% CI: 1.32-1.85). The applicability of HRV measurement in preventive settings is discussed.

Bibliometric Properties of Placebo Literature From the JIPS Database: A Descriptive Study.

Objectives: First dedicated articles about placebo effects have been published in the 1940s, and more than 5,000 articles have been published in scientific organs since. However, the evolution of this research field has rarely been examined. By means of bibliometric analyses we aim to generate research metrics such as the number and types of publications as well as topics, authorship networks, impacts, and future directions. Methods: Bibliometric methods were applied to the Journal of Interdisciplinary Placebo Studies (JIPS) database. It comprises around 5,000 scientific articles dedicated to researching placebo effects and mechanisms and is expanded continually through individual curation, making it a prime candidate for investigation. Web scraping was used to obtain complete article information from PubMed and Web of Science. The same information was obtained for addiction research as reference field. Analyses include a general characterization of the database as well as focus points concerning publication types (data vs. non-data articles), high-impact publications and more. Results: Analyses show that the JIPS database is a comprehensive collection of placebo publications. The development of the field is comparable to that of the comparator field and scientific publication in general. The most frequently used keywords describe populations or study design topics; the most frequent symptoms were pain, depression and anxiety. Data and non-data (e.g., review) papers are related in proportion of about 6:4 in recent decades, indicating a stable degree of productivity. A network of 26 interconnected researchers was identified who published 25 or more articles. Placebo research contributes comparable numbers of publications to high-impact journals as the comparator field. Several additional analyses are performed, with a focus on visualization of various database parameters. Conclusions: Bibliometric analyses of the JIPS database can be used to answer questions to the field, for example, to get an impression of blind spots and future directions. However, keywords used in indexing and publications themselves are often general and suggest that placebo research may still be considered a subspecialty of superordinate fields, particularly since there are no journals dedicated to placebo research itself. We invite interested colleagues to use this database for further analyses.

[egePan-VOICE study on the psychosocial burden of the Covid-19 pandemic among - medical technical assistants]. / egePan-VOICE-Studie zur psychosozialen Belastung durch die Covid-19-Pandemie bei medizinischtechnischen Assistent*innen.

egePan-VOICE study on the psychosocial burden of the Covid-19 pandemic among - medical technical assistants Objectives: The Covid-19 pandemic is associated with increased demands on healthcare workers. A previously neglected occupational group is medical technical assistants (MTA). The aim is therefore to identify stress factors among MTA in Germany during the pandemic. Methods: A cross-sectional online survey of medical staff was conducted in spring 2020 (N = 8088). Results: N = 1483 records of MTA were analyzed. Retrospectively, the stress increased under the pandemic, and 60.1 % of MTA suffered from work stress (ERI). Staff shortages and extra work were associated with an increase in work stress. Problems of work-life balance and contact with contaminated material/infected persons favored stressful experiences. Conclusions: Some working conditions in the pandemic pose a potential health risk to MTA. It seems necessary to create improvements in the general conditions that enable healthily and effective work.

Psychosocial Impact of the COVID-19 Pandemic on Healthcare Workers and Initial Areas of Action for Intervention and Prevention-The egePan/VOICE Study.

INTRODUCTION: Epidemics lead to an increase in occupational stress and psychological strain among healthcare workers. However, the impact of a pandemic outbreak on healthcare systems is yet to be clearly defined. Therefore, this work aims to describe and analyze specific areas of workload among different groups of healthcare workers during the first wave of the COVID-19 pandemic. METHODS: A sample of N = 8088 persons working in the German-speaking healthcare sector participated in the VOICE/egePan online survey, which addressed the impact of the COVID-19 pandemic during the second quarter of 2020. We used 15 self-constructed items, based on the work of Matsuishi et al. (2012), to identify potential COVID-19-specific topics. RESULTS: N = 7542 records of healthcare workers were analyzed. Of these, 60.80% reported, retrospectively, an increase in stress since the outbreak of the pandemic. Problem areas tended to be indicated more frequently by the women surveyed than by the men. Nurses, paramedics and medical technicians reported the highest fear of infecting others while physicians reported the highest fear of physical or mental exhaustion. With respect to age, older respondents indicated less fear and felt more protected. Men and people living alone were more likely to use dysfunctional coping strategies. Migrants reported a higher fear of becoming infected or infecting others as well as they reported about increased levels of smoking. DISCUSSION: Retrospectively, the COVID-19 pandemic led to an increase in stress among healthcare workers. Problem areas have different focuses with regard to different living situations, environmental conditions and professions. In order to lay the best basis for healthy and efficient work, it seems necessary to take measures especially tailored to the needs of different groups of healthcare workers.

The mediating role of COVID-19-related burden in the association between adverse childhood experiences and emotional exhaustion: results of the egePan - VOICE study.

Background: Adverse childhood experiences (ACEs) increase the risk for mental health problems. However, there is a lack of data targeting the role of ACEs for one of the most prevalent mental health problems in health-care professionals: burnout. Objective: We aimed to assess the relationship between ACEs and the core burnout dimension 'emotional exhaustion' (EE). As health-care professionals have been facing particular challenges during the COVID-19 pandemic, we furthermore aimed to assess the role of COVID-19 associated burden in the interplay between ACEs and EE. Methods: During the first lockdown in Germany, a total of 2500 medical healthcare professionals were questioned in a cross-sectional online survey. Questions targeted, among others, sociodemographics, ACEs, COVID-19-associated problems (e.g. increase of workload, worries about relatives and patients) and emotional exhaustion, measured by the respective dimension of the Maslach Burnout Inventory (MBI). Results: In German health-care professionals, ACEs were associated with a higher EE score. The number of experienced ACEs was associated with the majority of assessed COVID-19-associated problems. An increasing number of ACEs predicted higher EE scores, controlling for gender. The association between ACEs and EE was mediated significantly by COVID-19-associated problems. These included maladaptive coping strategies such as increased smoking, drinking and use of antidepressants/tranquilizers, feeling less protected by measures of the employee or the state, a greater feeling of being burdened by COVID-19-associated problems and greater exhaustion and sleep problems. Conclusion: Our findings suggest ACEs as significant risk factor for EE in German health-care professionals. The current pandemic means a significant burden that further pronounces this risk.

Antecedentes: Las experiencias adversas en la niñez (ACEs en sus siglas en inglés) aumentan el riesgo de problemas de salud mental. Sin embargo, faltan datos sobre el papel de las ACEs en uno de los problemas de salud mental más prevalentes en los profesionales de la salud: el agotamiento (burnout).Objetivo: Nuestro objetivo fue evaluar la relación entre las ACEs y la dimensión central del agotamiento 'agotamiento emocional' (AE). Dado que los profesionales de la salud se han enfrentado a desafíos particulares durante la pandemia de COVID-19, además nos propusimos evaluar el papel de la carga asociada a COVID-19 en la interacción entre las ACEs y la AE.Métodos: Durante la primera cuarentena en Alemania, se interrogó a un total de 2500 profesionales de la salud en una encuesta transversal en línea. Las preguntas fueron dirigidas, entre otros, a datos sociodemográficos, ACEs, problemas asociados a COVID-19 (por ejemplo, aumento de la carga de trabajo, preocupaciones sobre familiares y pacientes) y agotamiento emocional, medidos por la dimensión respectiva del Maslach Burnout Inventory (MBI).Resultados: En los profesionales sanitarios alemanes, las ACEs se asociaron con una puntuación de AE más alta. El número de ACEs experimentados se asoció con la mayoría de los problemas asociados a COVID-19 evaluados. Un mayor número de ACEs predijo puntuaciones de AE más altas, controlado por género. La asociación entre ACEs y AE fue mediada significativamente por problemas asociados con COVID-19. Estos incluyeron estrategias de afrontamiento desadaptativas, como fumar, beber y usar antidepresivos/tranquilizantes, sentirse menos protegido por las medidas del empleador o el estado, una mayor sensación de estar agobiado por los problemas asociados con COVID-19 y un mayor agotamiento y problemas de sueño.Conclusión: Nuestros hallazgos sugieren que las ACEs son un factor de riesgo significativo para la AE en los profesionales de la salud alemanes. La pandemia actual implica una carga importante que acentúa aún más este riesgo.

Decreased Autonomic Reactivity and Psychiatric Comorbidities in Neurological Patients With Medically Unexplained Sensory Symptoms: A Case-Control Study.

Up to 48% of patients with medically unexplained symptoms seen in neurological practice suffer from sensory symptoms, which could be of functional nature or secondary to psychiatric disorders. These patients show high medical care utilization causing elevated healthcare costs. Despite the high prevalence, little is known about clinical characteristics and pathophysiological mechanisms. For functional disorders such as irritable bowel syndrome, a reduction of heart rate variability (HRV) has been shown, suggesting a dysfunction of the autonomic nervous system (ANS). The aim of this study was to investigate psychological data and functional changes of the ANS in patients with medically unexplained sensory symptoms (MUSS). In this exploratory pilot study, 16 patients (11 females, 31.6 ± 11.9 years) with MUSS, who were recruited at a single tertiary neurological center, underwent a structured clinical interview (SCID) to evaluate psychiatric comorbidities. Patients and age- and sex-matched healthy volunteers filled in questionnaires, and individual sensory thresholds (perception, pain) were detected by quantitative sensory testing (QST). HRV was assessed at baseline and under three different experimental conditions (tonic pain stimulus, placebo application, cold-face test). All tests were repeated after 6-8 weeks. SCID interviews revealed clinical or subclinical diagnoses of psychiatric comorbidities for 12 patients. Questionnaires assessing somatization, depression, anxiety, and perceived stress significantly discriminated between patients with MUSS and healthy controls. While there was no difference in QST, reduced ANS reactivity was found in patients during experimental conditions, particularly with regard to vagally mediated HRV. Our pilot study of neurological patients with MUSS reveals a high prevalence of psychiatric comorbidities and provides evidence for altered ANS function. Our data thus give insight in possible underlying mechanisms for these symptoms and may open the door for a better diagnostic and therapeutic approach for these patients in the future.

Believing is achieving - On the role of treatment expectation in neurofeedback applications.

In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.

The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity.

BACKGROUND: Health games provide opportunities for the treatment and prevention of childhood obesity. We developed a motion-controlled serious game for children that addresses 3 core topics of nutrition, physical activity, and stress coping. It is the first serious game that extensively targets the dietary energy density principle (DED-P) in relation to nutrition. The game is intended to provide an additional educational component for the prevention and treatment of obesity in children. OBJECTIVE: The Kids Obesity Prevention study aimed to evaluate the newly developed game and to evaluate how well children are able to understand and apply the DED-P. METHODS: This cluster randomized controlled trial collected data from 82 primary school children aged 9 to 12 years and their parents at baseline (T0), at 2 weeks after study commencement (T1), and at the 4-week follow-up (T2). The dropout rate was 3.6%. The intervention group (IG) played the game within 2 weeks (2 sessions with different game modules). One part of the game involves selection of food with the lower energy density when presented with a pair of foods. This allows assessment of whether the children have understood the DED-P and whether they can apply it to unknown foods under time pressure. The control group (CG) received a brochure about the food pyramid concept and physical activity. The primary outcome was the gain in knowledge (nutrition and stress coping) and measured with a pretested questionnaire. The secondary outcomes were the maintenance of knowledge, application of the DED-P, feelings during game play, game acceptance, and behavioral measures (physical activity, media consumption, and dietary intake). RESULTS: The knowledge score ranging from 0 to 100 increased from T0 (IG: 53 [SD 10], CG: 50 [SD 11]) to T1 (IG: 69 [SD 11], CG: 52 [SD 12]) in IG versus CG (P<.001). At T2, the knowledge score of IG remained at the same level as that of T1. Game data showed that after DED-P education, the classification under time pressure of unknown versus known food pairs according to their DED category was similar (hit rate around 70%). Overall, 95% of the children liked the game very much or much. No group changes were observed at the behavioral level. CONCLUSIONS: The Kids Obesity Prevention program sustainably increased knowledge in the areas of nutrition and stress coping, and children were able to apply the DED-P. TRIAL REGISTRATION: ClinicalTrials.gov NCT02551978; https://clinicaltrials.gov/ct2/show/NCT02551978.

Effects of Expectancy on Cognitive Performance, Mood, and Psychophysiology in Healthy Adolescents and Their Parents in an Experimental Study.

OBJECTIVE: Placebo effects on cognitive performance and mood and their underlying mechanisms have rarely been investigated in adolescents. Therefore, the following hypotheses were investigated with an experimental paradigm: (1) placebo effects could be larger in adolescents than in adults, (2) parents' expectations influence their adolescents' expectations and placebo effects, and (3) a decrease in stress levels could be an underlying mechanism of placebo effects. METHODS: Twenty-six healthy adolescents (13.8 ± 1.6 years, 14 girls) each with a parent (45.5 ± 4.2 years, 17 mothers) took part in an experimental within-subjects study. On two occasions, a transdermal patch was applied to their hips and they received an envelope containing either the information that it is a Ginkgo patch to improve cognitive performance and mood, or it is an inactive placebo patch, in counterbalanced order. Cognitive performance and mood were assessed with a parametric Go/No-Go task (PGNG), a modification of California Verbal Learning Test, and Profile of Mood Scales (POMS). Subjects rated their expectations about Ginkgo's effects before patch application as well as their subjective assessment of its effects after the tests. An electrocardiogram and skin conductance levels (SCLs) were recorded and root mean square of successive differences (RMSSD), high-frequency power (HF), and the area under the curve of the SCL (AUC) were analyzed as psychophysiological stress markers. RESULTS: Expectations did not differ between adolescents and parents and were correlated concerning reaction times only. Overall, expectations did not influence placebo effects. There was only one significant placebo effect on the percentage of correct inhibited trials in one level of the PGNG in adolescents, but not in parents. RMSSD and HF significantly increased, and AUC decreased from pre- to post-patch application in adolescents, but not in parents. CONCLUSION: With this experimental paradigm, we could not induce relevant placebo effects in adolescents and parents. This could be due to aspects of the study design such as application form and substance, and that healthy subjects were employed. Nevertheless, we could show that adolescents are more sensitive to psychophysiological reactions related with interventions which could be part of the underlying mechanisms of placebo effects in adolescents.

"Placebo by Proxy" and "Nocebo by Proxy" in Children: A Review of Parents' Role in Treatment Outcomes.

The "placebo (effect) by proxy" (PbP) concept, introduced by Grelotti and Kaptchuk (1), describes a positive effect of a patient's treatment on persons in their surrounding such as family members or healthcare providers, who feel better because the patient is being treated. The PbP effect is a complex dynamic phenomenon which attempts to explain a change in treatment outcome arising from an interaction between a patient and an effect from proxies such as parents, caregivers, physicians or even the media. By extension the effect of the proxy can also have a negative or adverse effect whereby a proxy feels worse when a patient is treated, giving rise to the possibility of a "nocebo (effect) by proxy" (NbP), and by extension can influence a patient's treatment response. While this has yet to be systematically investigated, such an effect could occur when a proxy observes that a treatment is ineffective or is perceived as causing adverse effects leading the patient to experience side effects. In this narrative review, we take these definitions one step further to include the impact of PbP/NbP as they transform to affect the treatment outcome for the patient or child being treated, not just the people surrounding the individual being treated. Following a systematic search of literature on the subject using the Journal of Interdisciplinary Placebo Studies (JIPS) database (https://jips.online) and PubMed (NCBI) resulted in very few relevant studies, especially in children. The effect of PbP per se has been studied in parents and their children for temper tantrums, acupuncture for postoperative symptoms, as well as for neuroprotection in very preterm-born infants. This paper will review the PbP/NbP concepts, show evidence for its presence in children's treatment outcome and introduce clinical implications. We will also offer suggestions for future research to further our understanding of the role of the proxy in promoting or distracting from treatment benefit in children. Increasing an appreciation of the PbP and NbP phenomena and the role of the proxy in children's treatment should improve research study design and ultimately harness them to improve clinical child healthcare.

Long-Term Attitude Change After a Single-Day Manager Training Addressing Mental Health at the Workplace.

Mental health problems have become one of the most common causes of incapacity for work, and engender high costs to society. Especially managerial behavior was found to have a great impact on employees' well-being. In order to support those in leading positions in dealing with their own, as well as their employees', psychological stress factors, we conducted a specific manager training. At the same time, we wanted to find out about the training's short- and long-term effects. Participants were asked to give information about their knowledge and attitudes concerning mental health (Mental Health Knowledge Schedule, Social Distance Scale), as well as to comment on their own health condition (12-Item Short Form Health Survey, Patient Health Questionnaire) and working situation (Effort-Reward Inventory, Irritation Scale). Data were collected at baseline, as well as 3 and 12 months after the training. Results show long-term improvements in knowledge and attitudes measured by the Mental Health Knowledge Schedule (MAKS: Mt1 = 22.88, Mt2 = 23.79, Mt3 = 23.79, p = 0.005) but not in the Social Distance Scale (SoDi: Mt1 = 0.96, Mt2 = 0.85, Mt3 = 0.84, p = 0.165). Over the period of time observed, no changes were found regarding health- or work-related instruments. Due to the uncontrolled design of the study, further research is needed to determine the exact effectiveness.