Child Sexual Abuse by Catholic Priests, Deacons, and Male Members of Religious Orders in the Authority of the German Bishops’ Conference 1946–2014

This study explores the extent of sexual abuse of minors by members of the Catholic Church in Germany. It is the first comprehensive study to examine this extent in a European country. The goals of this study are as follows: (a) to analyze whether the extent and characteristics of sexual abuse in a European country are comparable to those in the United States and Australia and (b) how discrepancies can be explained. The personnel files of 38,156 Catholic Priests, deacons, and male members of religious orders in the authority of the German Bishops’ Conference were analyzed. The study period lasted from 1946 to 2014. All 27 German dioceses took part in this study. A total of 4.4% of all clerics (N = 1,670) from 1946 to 2014 were alleged to have committed sexual abuse, and 3,677 children or adolescents were identified as victims. These results are similar to those from comparable studies in the United States. Sexual abuse of minors within the authority of the Catholic Church seems to be a worldwide phenomenon

Pharmacological interventions to reduce violence in patients with schizophrenia in forensic psychiatry.

Abstract Background The purpose was to systematically investigate which pharmacological strategies are effective to reduce the risk of violence among patients with Schizophrenia Spectrum Disorders (SSD) in forensic settings. Methods For this systematic review six electronic data bases were searched. Two researchers independently screened the 6,003 abstracts resulting in 143 potential papers. These were then analyzed in detail by two independent researchers. Of these, 133 were excluded for various reasons leaving 10 articles in the present review. Results Of the 10 articles included, five were merely observational, and three were pre-post studies without controls. One study applied a matched case-control design and one was a non-randomized controlled trial. Clozapine was investigated most frequently, followed by olanzapine and risperidone. Often, outcome measures were specific to the study and sample sizes were small. Frequently, relevant methodological information was missing. Due to heterogeneous study designs and outcomes meta-analytic methods could not be applied. Conclusion Due to substantial methodological limitations it is difficult to draw any firm conclusions about the most effective pharmacological strategies to reduce the risk of violence in patents with SSD in forensic psychiatry settings. Studies applying more rigorous methods regarding case-definition, outcome measures, sample sizes, and study designs are urgently needed

Neurocognition and social cognition in patients with schizophrenia spectrum disorders with and without a history of violence: results of a multinational European study

Objective: Neurocognitive impairment has been extensively studied in people with schizophrenia spectrum disorders and seems to be one of the major determinants of functional outcome in this clinical population. Data exploring the link between neuropsychological deficits and the risk of violence in schizophrenia has been more inconsistent. In this study, we analyse the differential predictive potential of neurocognition and social cognition to discriminate patients with schizophrenia spectrum disorders with and without a history of severe violence. Methods: Overall, 398 (221 cases and 177 controls) patients were recruited in forensic and general psychiatric settings across five European countries and assessed using a standardized battery. Results: Education and processing speed were the strongest discriminators between forensic and non-forensic patients, followed by emotion recognition. In particular, increased accuracy for anger recognition was the most distinctive feature of the forensic group. Conclusions: These results may have important clinical implications, suggesting potential enhancements of the assessment and treatment of patients with schizophrenia spectrum disorders with a history of violence, who may benefit from consideration of socio-cognitive skills commonly neglected in ordinary clinical practice

A comparison of temporal and location-based sampling strategies for GPS-triggered electronic diaries

Self-reporting is a well-established approach within the medical and psychological sciences. In order to avoid recall bias, i.e. past events being remembered inaccurately, the reports can be filled out on a smartphone in real-time and in the natural environment. This is often referred to as ambulatory assessment and the reports are usually triggered at regular time intervals. With this sampling scheme, however, rare events (e.g. a visit to a park or recreation area) are likely to be missed. When addressing the correlation between mood and the environment, it may therefore be beneficial to include participant locations within the ambulatory assessment sampling scheme. Based on the geographical coordinates, the database query system then decides if a self-report should be triggered or not. We simulated four different ambulatory assessment sampling schemes based on movement data (coordinates by minute) from 143 voluntary participants tracked for seven consecutive days. Two location-based sampling schemes incorporating the environmental characteristics (land use and population density) at each participant’s location were introduced and compared to a time-based sampling scheme triggering a report on the hour as well as to a sampling scheme incorporating physical activity. We show that location-based sampling schemes trigger a report less often, but we obtain more unique trigger positions and a greater spatial spread in comparison to sampling strategies based on time and distance. Additionally, the location-based methods trigger significantly more often at rarely visited types of land use and less often outside the study region where no underlying environmental data are available

School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium

Abstract Background Schools are an ideal setting in which to promote health. However, empirical data on the effectiveness of school-based mental health promotion programs are rare, and research on universal Internet-based prevention in schools is almost non-existent. Following the life skills approach, stress management training is an important component of health promotion. Mental health literacy is also associated with mental health status, and it facilitates formal help-seeking by children and adolescents (C&A). The main objectives of this study are (1) the development and evaluation of an Internet-based version of a universal school-based health promotion program called StresSOS and (2) demonstrating non-inferiority of the online setting compared to the face-to-face setting. StresSOS aims to improve stress management and mental health literacy in C&A. Methods/design A school-based sample of 15,000 C&A (grades 6–13 and older than 12 years) will be recruited in five regions of Germany within the ProHEAD Consortium. Those with a screening result at baseline indicating no mental health problems will be invited to participate in a randomized controlled trial comparing StresSOS online to an active online control condition (Study A). In addition, 420 adolescents recruited as a separate school-based sample will participate in the StresSOS face-to-face intervention. Participants in both intervention groups (online or face-to-face) will receive the same eight treatment modules to allow for the comparison of both methods of delivery (Study B). The primary outcome is the number of C&A with symptoms of mental health problems at a 12 months follow-up. Secondary outcomes are related to stress/coping (i.e., knowledge, symptoms of stress, coping resources), mental health literacy (knowledge and attitudes toward mental disorders and help-seeking), program usage patterns, cost-effectiveness, and acceptability of the intervention. Discussion This study represents the first adequately powered non-inferiority trial in the area of school-based mental health promotion. If online StresSOS proves efficacious and non-inferior to face-to-face delivery, this offers great potential for health promotion in youths, both in and outside the school environment. Trial registration German Clinical Trials Register, DRKS00014693 . Registered on 14 May 2018

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium

Background: The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The present trial evaluates the efficacy and cost-effectiveness of two new interventions (based on dissonance theory and principles of cognitive behavioral therapy (CBT)) that are implemented as add-ons to the existing Internet-based ED prevention program ProYouth. Methods: The trial is one of five sub-projects of the German multicenter consortium ProHEAD. It is a three-arm, parallel, randomized controlled superiority trial. Participants will be randomized to (1) the online program ProYouth (active control condition) or (2) ProYouth plus a structured dissonance-based module or (3) ProYouth plus a CBT-based chat group intervention. As part of ProHEAD, a representative school-based sample of N = 15,000 students (≥ 12 years) will be screened for mental health problems. N = 309 participants at risk for ED (assessed with the Weight Concerns Scale (WCS) and the Short Evaluation of Eating Disorders (SEED)) will be included in the present trial. Online assessments will be conducted at baseline, at end of intervention (6 weeks), at 6 months follow-up, and — as part of ProHEAD - at 12 and 24 months follow-up. The primary outcome is ED-related impairment (assessed with the Child version of the Eating Disorder Examination-Questionnaire (ChEDE-Q)) at the end of the intervention. Secondary outcomes include ED-related symptomatology at follow-up, ED-related stigma, ED-related help-seeking, and acceptance of and compliance with the interventions. For the health economic evaluation data on costs of the interventions, healthcare utilization and health-related quality of life will be assessed. Discussion: This is the first study augmenting a flexible prevention approach such as ProYouth with structured evidence-based modules in order to overcome some of the key limitations in the current practice of ED prevention. Trial registration: German Clinical Trials Register (DRKS), DRKS00014679. Registered on 25 April 2018

Promoting Help-seeking using E-technology for ADolescents with mental health problems: study protocol for a randomized controlled trial within the ProHEAD Consortium

Background The highest incidence and prevalence of mental health problems across the lifespan as well as the first onset of most long-term mental health conditions are reported for youths between 14 and 25 years of age. At the same time, only 25% of adolescents with mental health problems receive professional treatment. One explanation for poor treatment access in youths is their low help-seeking behavior. Barriers that can keep children and adolescents (C&A) from seeking professional help include a lack of perceived need, structural barriers, or stigma. Interventions based on e-technology might present an effective approach, overcoming these barriers by reducing stigma and providing low-threshold access with enhanced reach, ultimately facilitating help-seeking for mental health problems among youths. Methods: The study is designed as a multi-center, randomized controlled trial. In total, an estimated number of n = 1,500 C&A with mental health problems, drawn from a school-based sample of n = 15,000 pupils attending school grades 6 to 13 (≥ 12 years of age), recruited in five regions of Germany, will be randomized either to an intervention (ProHEAD online) or a control condition. C&A in the intervention group will receive online access to tailored information and individual advice on where to seek professional help for their specific needs close to their place of living, case reports of and interaction with peers, as well as the opportunity for online and telephone counseling. C&A in the control intervention will receive a recommendation to seek help and online information on where to find professional help. All participants will be asked to complete questionnaires concerning their help-seeking behavior at baseline, during the intervention (monitoring), and also at a 1 and 2 year follow-up. The primary endpoint is the number of C&A seeking conventional face-to-face professional help in the real-world setting within 1 year after their initial screening. Discussion: The trial will investigate if an Internet-based intervention can increase professional help-seeking in C&A with mental health problems. With its randomized controlled design and large-scale school-based sampling, the study aims to overcome the shortages of previous research. The intervention has the potential to narrow the treatment gap in C&A and to ultimately improve the mental health care system. Trial registration: German Clinical Trials Register, DRKS00014685. Registered on 7 July, 2018

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium

Background: Early and excessive alcohol use is a significant threat to healthy development. Evidence supports the effectiveness of electronic alcohol interventions for young drinkers. However, effects are typically small and studies targeting under 18-year-olds are scarce. This trial is the first to evaluate the effectiveness of a single-session, brief, motivational, web-based intervention (ProWISE) plus weekly text-message-initiated individualised prompts (TIPs) in reducing alcohol consumption and alcohol-related harm among children and adolescents aged ≥ 12 years. TIPs are designed to decrease risky alcohol use by reaching youth in the contexts of their everyday lives and by providing individualised feedback on drinking intentions, actual drinking and succession in achieving personal goals for low-risk drinking or abstinence. Methods/Design: The trial is part of the multicentre consortium ProHEAD testing e-interventions for mental health problems in children and adolescents. Participants in grades 6–13 aged ≥ 12 years will be recruited in schools which participate in ProHEAD (target N = 15,000). Main criterion for inclusion in the ProWISE-TIP trial is a positive screening for at-risk alcohol use in the CRAFFT-d questionnaire (target n = 1076). In a multicentre, four-arm, randomised controlled design the following groups will be compared: (A) web-based intervention plus TIPs for 12 weeks; (B) web-based intervention plus text-message-initiated assessment of alcohol consumption for 12 weeks; (C) web-based intervention only; and (D) alcohol-related psychoeducation. TIPs will be delivered shortly before and after high-risk situations for excessive alcohol use and will be tailored to age, gender, drinking motives and alcohol consumption. Study participants will be followed up at three, six and nine months in the ProWISE-TIP trial and at one and two years in the ProHEAD consortium. Primary outcome is alcohol use in the past 30 days at nine months after enrolment. Secondary outcomes are alcohol-related problems, co-occurring substance use, health service utilisation, mental health problems and quality of life. Discussion: Trial results will generate important evidence on how to enhance effectiveness of single-session, web-based alcohol interventions for youth. The ProWISE-TIP intervention, if effective, can be used as a stand-alone alcohol intervention or as an add-on to school-based or community-based alcohol prevention programs. Trial registration German Clinical Trials Register, DRKS00014606. Registered on 20 April 2018

Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: a multi-centred randomized controlled trial

BACKGROUND: Current evidence points towards a high prevalence of psychological distress in refugee populations, contrasting with a scarcity of resources and amplified by linguistic, institutional, financial, and cultural barriers. The objective of the study is to investigate the overall effectiveness and cost-effectiveness of a Stepped Care and Collaborative Model (SCCM) at reducing depressive symptoms in refugees, compared with the overall routine care practices within Germany's mental healthcare system (treatment-as-usual, TAU). METHODS: A multicentre, clinician-blinded, randomised, controlled trial was conducted across seven university sites in Germany. Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12. Participants were randomly allocated to one of two treatment arms (SCCM or TAU) for an intervention period of three months between April 2018 and March 2020. In the SCCM, participants were allocated to interventions tailored to their symptom severity, including watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment. The primary endpoint was defined as the change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) after 12 weeks. The secondary outcome was the change in Montgomery Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention. FINDINGS: The intention-to-treat sample included 584 participants who were randomized to the SCCM (n= 294) or TAU (n=290). Using a mixed-effects general linear model with time, and the interaction of time by randomisation group as fixed effects and study site as random effect, we found significant effects for time (p < .001) and time by group interaction (p < .05) for intention-to-treat and per-protocol analysis. Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T(1) 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T(1) 0.57, 95% CI 0.40 to 0.74, p < .001). Cost-effectiveness and net monetary benefit analyses provided evidence of cost-effectiveness for the primary outcome and quality-adjusted life years. Robustness of results were confirmed by sensitivity analyses. INTERPRETATION: The SSCM resulted in a more effective and cost-effective reduction of depressive symptoms compared with TAU. Findings suggest a suitable model to provide mental health services in circumstances where resources are limited, particularly in the context of forced migration and pandemics. FUNDING: This project is funded by the Innovationsfond and German Ministry of Health [grant number 01VSF16061]. The present trial is registered under Clinical-Trials.gov under the registration number: NCT03109028. https://clinicaltrials.gov/ct2/show/NCT0310902

School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium

Abstract Background Schools are an ideal setting in which to promote health. However, empirical data on the effectiveness of school-based mental health promotion programs are rare, and research on universal Internet-based prevention in schools is almost non-existent. Following the life skills approach, stress management training is an important component of health promotion. Mental health literacy is also associated with mental health status, and it facilitates formal help-seeking by children and adolescents (C&amp;A). The main objectives of this study are (1) the development and evaluation of an Internet-based version of a universal school-based health promotion program called StresSOS and (2) demonstrating non-inferiority of the online setting compared to the face-to-face setting. StresSOS aims to improve stress management and mental health literacy in C&amp;A. Methods/design A school-based sample of 15,000 C&amp;A (grades 6–13 and older than 12 years) will be recruited in five regions of Germany within the ProHEAD Consortium. Those with a screening result at baseline indicating no mental health problems will be invited to participate in a randomized controlled trial comparing StresSOS online to an active online control condition (Study A). In addition, 420 adolescents recruited as a separate school-based sample will participate in the StresSOS face-to-face intervention. Participants in both intervention groups (online or face-to-face) will receive the same eight treatment modules to allow for the comparison of both methods of delivery (Study B). The primary outcome is the number of C&amp;A with symptoms of mental health problems at a 12 months follow-up. Secondary outcomes are related to stress/coping (i.e., knowledge, symptoms of stress, coping resources), mental health literacy (knowledge and attitudes toward mental disorders and help-seeking), program usage patterns, cost-effectiveness, and acceptability of the intervention. Discussion This study represents the first adequately powered non-inferiority trial in the area of school-based mental health promotion. If online StresSOS proves efficacious and non-inferior to face-to-face delivery, this offers great potential for health promotion in youths, both in and outside the school environment. Trial registration German Clinical Trials Register, DRKS00014693 . Registered on 14 May 2018