Adapting the randomised controlled trial (RCT) for precision medicine: introducing the nested-precision RCT (npRCT)

Adaptations to the gold standard randomised controlled trial (RCT) have been introduced to decrease trial costs and avoid high sample sizes. To facilitate development of precision medicine algorithms that aim to optimise treatment allocation for individual patients, we propose a new RCT adaptation termed the nested-precision RCT (npRCT). The npRCT combines a traditional RCT (intervention A versus B) with a precision RCT (stratified versus randomised allocation to A or B). This combination allows online development of a precision algorithm, thus providing an integrated platform for algorithm development and its testing. Moreover, as both the traditional and the precision RCT include participants randomised to interventions of interest, data from these participants can be jointly analysed to determine the comparative effectiveness of intervention A versus B, thus increasing statistical power. We quantify savings of the npRCT compared to two independent RCTs by highlighting sample size requirements for different target effect sizes and by introducing an open-source power calculation app. We describe important practical considerations such as blinding issues and potential biases that need to be considered when designing an npRCT. We also highlight limitations and research contexts that are less suited for an npRCT. In conclusion, we introduce the npRCT as a novel precision medicine trial design strategy which may provide one opportunity to efficiently combine traditional and precision RCTs

Der Holocaust im Film : Dokumentation des Untersuchungsmaterials einer quasiexperimentellen Studie

Filmischen Aufarbeitungen des Holocaust wurde wiederholt vorgeworfen, kontraindizierte Effekte zur Folge zu haben. Aufbauend auf dieser theoretischen Kritik wird ein Kodiermanual zur Inhaltsanalyse von TV-Dokumentationen und Filmen über den Holocaust vorgestellt. Dieses untergliedert sich in vier Bereiche zu (1) Quellen und Perspektiven, (2) Bezug zur Opferseite, (3) Bezug zur Täterseite und (4) formale Kriterien. Anschließend werden die Ergebnisse einer Inhaltsanalyse von sechs Filmausschnitten über den Genozid an den Juden während des NS-Regimes berichtet

Identity narratives and group-based emotions

This work deals with how individuals construct national identity narratives and how these narratives are related to group-based emotions of shame and guilt. Specifically, it explores this association in situations of threat when individuals are confronted with historical wrongdoings, which menace the moral integrity of their national in-group; furthermore it investigates the relations to willingness for reconciliation and reparations.First, the content model of national narratives is outlined. Starting from a critical literature review on different forms of national attachment and on theoretical differentiations between civic and ethnic concepts of nationhood, the model is developed based on a content analytical and exploratory bottom up approach in order to cover the entire range of national identity contents in the United States and Germany (Study 1). Beside an ideology-based identity, characterized by abstract values such as freedom, and a heritage-based identity, distinguished by cultural traditions, the model identifies a conceptually new identity pattern: the formalistic identity narrative, which stands out because of its very instrumental and pragmatic approach to national identity. After the identified national narratives are replicated and validated in two experimental online-studies (partial Studies 2a and 2b), identity positioning is tested in response to historical wrongdoings, slavery in the US and the Holocaust in Germany. Intermediate results show that identity positioning and the restructuring of national narratives appear to be considered an adequate reaction towards threat in heritage-based identity dominated contexts.In a second step, this research addresses the paradox of group-identification, which describes in two competing explanations the effect of group-identification increasing respectively decreasing levels of aversive group-based emotions like shame and guilt. In this research, two different approaches were chosen by applying the content model of national narratives (identity content perspective) and by differentiating between two different forms of image shame and moral shame (emotion perspective). The results provide evidence for the notion that especially ideology-based identifiers are able to admit image-shame. They further show that identification decreases moral emotions like moral shame and guilt, whereas collective narcissism increases image-shame. Thus, the experimental studies suggest to take into account both, identity contents as well as differentiated emotional concepts, to develop a better understanding of the interplay between national narratives and emotions. The important (positive) impact of group-based shame and guilt is proven in the very last step of this thesis.The results stress that group-based emotions are able to effect the support for reconciliation and the constructive engagement with past injustice committed in the name of one’s nation

Human rights orientation and modern anti-Semitism

The manifestations of anti-Semitism in Germany have changed since the end of WWII. Whereas in the past German anti-Semitism was overtly racist, today it is characterized more by subtle and latent facets. How are these modern facets, such as secondary anti-Semitism, latent anti-Semitism and anti-Semitic criticism of Israel, related to human rights orientations? A survey of experts and a pre-study provided the basis for developing the Human Rights Orientation Scale, which includes the four subscales of Endorsement, Application, Restriction and Willingness to engage in human rights activity. In a study of 304 German subjects, data was collected on human rights orientations and facets of modern anti-Semitism. The present paper introduces the questionnaire, discusses the relevance of the study for determining the relationships between human rights orientations and facets of modern anti-Semitism and summarizes the study's implications for viewing secondary anti-Semitism and prejudicial criticism of Israel as facets of modern anti-Semitism

Engaging with German history: Reactions of the third post-war generation to cinematic representations of the Holocaust

Because the number of surviving contemporary witnesses of the Holocaust is rapidly declining, media reports are increasingly important for transmitting history to the “Third Generation.” The focus of this quasi-experimental study is on the recipient-side effects for school pupils of viewing TV documentaries that use different strategies to represent the Holocaust. For this purpose, 12 school classes (N = 184) were asked by questionnaire about their national identification and previous engagement with the Holocaust. Three weeks later, the study participants were shown one of six different film excerpts, whereby each film excerpt was viewed by respectively one group from Baden-Württemberg and one from Thüringen. The different reactions to the excerpts were sampled using standardized items and open-response essay questions. The results point to the conditions under which TV documentaries elicit contra-indexed effects and how enlightenment on past injustice can be achieved using cinematic material, without eliciting defensive reactions, and thereby make possible a constructive engagement with history

Shame on Me? Shame on You! Emotional Reactions to Cinematic Portrayals of the Holocaust

The media are playing an increasingly important role in teaching the public about the history of the Holocaust. In Germany, however, Holocaust documentaries have been criticized for eliciting unintended, adverse reactions among the viewers, such as distancing from the victims or calling for closing the books on the past. This criticism stems from the concern that such reactions pose an obstacle to critical-constructive engagement and coming to terms with history. This study examines the interplay between cinematic representation of the Holocaust, film-induced defensive strategies, and group-based emotions of shame. Based on a content analysis of six different film excerpts, we investigated the mediating effects of four defensiveness strategies (distancing from victims, victim blaming, closeness to perpetrators, and rejection of the relevance of the Holocaust) on group-based shame in a sample of 224 pupils from Germany’s third post-war generation in a quasi-experimental field study. The results reveal the complexity of film-portrayals which can foster as well as hinder group-based shame and thus, a constructive dealing with past injustice

Umgang mit der deutschen Geschichte: Reaktionen der 3. Nachkriegsgeneration auf filmische Darstellungen des Holocaust

Da ZeitzeugInnen des Holocaust seltener werden, steigt die Bedeutung von medialen Zeugnissen zur Geschichtsvermittlung an die „3. Generation“. Gegenstand dieser quasi-experimentellen Untersuchung sind rezipientenseitige Wirkungen von TV-Dokumentationen mit unterschiedlichen Darstellungsstrategien des Holocaust bei SchülerInnen. Hierzu wurden 12 Schulklassen (N = 184) per Fragebogen zu ihrer nationaler Identifikation und bisherigen Auseinandersetzung mit dem Holocaust befragt. Nach drei Wochen wurde einer von insgesamt sechs dokumentarischen Filmausschnitten zum Holocaust vorgeführt und die Reaktionen der SchülerInnen mit standardisierten Items und offenen Essay-Fragen erhoben. Die Ergebnisse zeigen auf, unter welchen Umständen TV-Dokumentationen kontraindizierte Wirkungen hervorrufen und wie durch filmische Mittel über vergangenes Unrecht aufgeklärt werden kann, ohne dass dies Abwehrreaktionen hervorruft und so eine konstruktive Auseinandersetzung mit der Geschichte möglich wird

Separating EEG correlates of stress: Cognitive effort, time pressure, and social‐evaluative threat

The prefrontal cortex is a key player in stress response regulation. Electroencephalographic (EEG) responses, such as a decrease in frontal alpha and an increase in frontal beta power, have been proposed to reflect stress-related brain activity. However, the stress response is likely composed of different parts such as cognitive effort, time pressure, and social-evaluative threat, which have not been distinguished in previous studies. This distinction, however, is crucial if we aim to establish reliable tools for early detection of stress-related conditions and monitoring of stress responses throughout treatment. This randomized cross-over study (N = 38) aimed to disentangle EEG correlates of stress. With linear mixed models accounting for missing values in some conditions, we found a decrease in frontal alpha and increase in beta power when performing the Paced Auditory Serial Addition Test (PASAT; cognitive effort; n = 32) compared to resting state (n = 33). No change in EEG power was found when the PASAT was performed under time pressure (n = 29) or when adding social-evaluative threat (video camera; n = 29). These findings suggest that frontal EEG power can discriminate stress from resting state but not more fine-grained differences of the stress response

Does an app designed to reduce repetitive negative thinking decrease depression and anxiety in young people? (RETHINK): a randomized controlled prevention trial

Abstract Background The first onset of common mental health disorders, such as mood and anxiety disorders, mostly lies in adolescence or young adulthood. Hence, effective and scalable prevention programs for this age group are urgently needed. Interventions focusing on repetitive negative thinking (RNT) appear especially promising as RNT is an important transdiagnostic process involved in the development of depression and anxiety disorders. First clinical trials indeed show positive effects of preventative interventions targeting RNT on adult as well as adolescent mental health. Self-help interventions that can be delivered via a mobile phone app may have the advantage of being highly scalable, thus facilitating prevention on a large scale. This trial aims to investigate whether an app-based RNT-focused intervention can reduce depressive and anxiety symptoms in young people at risk for mental health disorders. Methods The trial will be conducted in a sample (planned N = 351) of individuals aged 16–22 years with elevated levels of RNT but no current depression or anxiety disorder. In a randomized controlled between-subjects design, two versions of the app-based self-help intervention will be compared to a waiting list control condition. The full RNT-focused intervention encompasses a variety of RNT-reducing strategies, whereas the concreteness training intervention focuses on only one of these strategies, i.e., concrete thinking. The primary outcome (depressive symptoms) and secondary outcomes (anxiety symptoms and RNT) will be measured at pre-intervention, post-intervention (6 weeks after pre-intervention), and follow-up (18 weeks after pre-intervention). Discussion This trial aims to find out whether targeting RNT via an app is an effective and feasible way of preventing depression and anxiety disorders in adolescents. Since app-based interventions are highly scalable, this trial might contribute to tackling challenges related to the increasing rates of mental health disorders among young people. Trial registration https://www.drks.de , DRKS00027384. Registered on 21 February 2022—prospectively registered