Culturally adapted cognitive behavioural group therapy for mental disorders in refugees plus problem solving training (ReTreat): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Since a high proportion of refugees in Germany suffer from mental disorders, culturally adapted treatments are needed that target a broad range of symptoms. There is much evidence for the efficacy of culturally adapted cognitive behavioural therapy (CA-CBT). Given the promising results of CA-CBT, the combination with problem solving training (CA-CBT+) represents a novel approach that potentially improves the refugees' ability to cope actively with psychosocial problems. This randomised controlled trial evaluates the efficacy of 12-session outpatient CA-CBT+ compared with to treatment as usual (TAU) in a sample of refugees suffering from at least one DSM-5 disorder. METHODS AND ANALYSIS: The present study will be carried out as two-group randomised trial with 1:1 individual allocation to either (1) culturally adapted cognitive behavioural therapy in a group setting (CA-CBT+) or (2) TAU. The study takes place at four sites in Germany, randomising in total 138 adult refugees with at least one primary DSM-5 diagnosis to the treatment conditions. In CA-CBT+ the patients receive 12 sessions of 120 min duration over the course of 12 weeks providing psychoeducation, meditation and other techniques of emotional regulation, stretching and problem solving training. The primary outcome is treatment response operationalised by a clinically significant change in General Health Questionnaire (GHQ-28) score. Follow-up visits will take place 3 and 9 months after the end of the intervention. Secondary outcomes include changes in psychopathological symptoms, somatic symptoms and quality of life. Intention-to-treat analysis will be performed. Adverse and serious adverse events will be analysed. Further, healthcare usage and economic outcomes will be assessed and analysed. Primary and secondary outcomes will be analysed using appropriate statistical methods. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Commission of the German Psychological Society (ref: StangierUlrich2019-1018VA). Results will be disseminated via presentations, publication in international journals, and national outlets for clinicians. Furthermore, intervention materials will be available, and the existing network will be used to disseminate and implement the interventions into routine healthcare. TRIAL REGISTRATION NUMBER: DRKS00021536.

Safety of Triage Self-assessment Using a Symptom Assessment App for Walk-in Patients in the Emergency Care Setting: Observational Prospective Cross-sectional Study.

BACKGROUND: Increasing use of emergency departments (EDs) by patients with low urgency, combined with limited availability of medical staff, results in extended waiting times and delayed care. Technological approaches could possibly increase efficiency by providing urgency advice and symptom assessments. OBJECTIVE: The purpose of this study is to evaluate the safety of urgency advice provided by a symptom assessment app, Ada, in an ED. METHODS: The study was conducted at the interdisciplinary ED of Marburg University Hospital, with data collection performed between August 2019 and March 2020. This study had a single-center cross-sectional prospective observational design and included 378 patients. The app's urgency recommendation was compared with an established triage concept (Manchester Triage System [MTS]), including patients from the lower 3 MTS categories only. For all patients who were undertriaged, an expert physician panel assessed the case to detect potential avoidable hazardous situations (AHSs). RESULTS: Of 378 participants, 344 (91%) were triaged the same or more conservatively and 34 (8.9%) were undertriaged by the app. Of the 378 patients, 14 (3.7%) had received safe advice determined by the expert panel and 20 (5.3%) were considered to be potential AHS. Therefore, the assessment could be considered safe in 94.7% (358/378) of the patients when compared with the MTS assessment. From the 3 lowest MTS categories, 43.4% (164/378) of patients were not considered as emergency cases by the app, but could have been safely treated by a general practitioner or would not have required a physician consultation at all. CONCLUSIONS: The app provided urgency advice after patient self-triage that has a high rate of safety, a rate of undertriage, and a rate of triage with potential to be an AHS, equivalent to telephone triage by health care professionals while still being more conservative than direct ED triage. A large proportion of patients in the ED were not considered as emergency cases, which could possibly relieve ED burden if used at home. Further research should be conducted in the at-home setting to evaluate this hypothesis. TRIAL REGISTRATION: German Clinical Trial Registration DRKS00024909; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00024909.

Trauma-focused psychodynamic therapy and STAIR Narrative Therapy of post-traumatic stress disorder related to childhood maltreatment: trial protocol of a multicentre randomised controlled trial assessing psychological, neurobiological and health economic outcomes (ENHANCE).

INTRODUCTION: Success rates of psychotherapy in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM) are limited. METHODS AND ANALYSIS: Observer-blind multicentre randomised clinical trial (A-1) of 4-year duration comparing enhanced methods of STAIR Narrative Therapy (SNT) and of trauma-focused psychodynamic therapy (TF-PDT) each of up to 24 sessions with each other and a minimal attention waiting list in PTSD-CM. Primary outcome is severity of PTSD (Clinician-Administered PTSD Scale for DSM-5 total) assessed by masked raters. For SNT and TF-PDT, both superiority and non-inferiority will be tested. Intention-to-treat analysis (primary) and per-protocol analysis (secondary). Assessments at baseline, after 10 sessions, post-therapy/waiting period and at 6 and 12 months of follow-up. Adult patients of all sexes between 18 and 65 years with PTSD-CM will be included. Continuing stable medication is permitted. To be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions and concurrent psychotherapy. To be assessed for eligibility: n=600 patients, to be e randomly allocated to the study conditions: n=328. Data management, randomisation and monitoring will be performed by an independent European Clinical Research Infrastructure Network (ECRIN)-certified data coordinating centre for clinical trials (KKS Marburg). Report of AEs to a data monitoring and safety board. Complementing study A-1, four inter-related add-on projects, including subsamples of the treatment study A-1, will examine (1) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1); (2) biological parameters (B-2, eg, DNA damage, reactive oxygen species and telomere shortening); (3) structural and functional neural changes by neuroimaging (B-3) and (4) cost-effectiveness of the treatments (B-4, costs and utilities). ETHICS AND DISSEMINATION: Approval by the institutional review board of the University of Giessen (AZ 168/19). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media. TRIAL REGISTRATION NUMBER: DRKS 00021142.

Joint recommendations for a total services account as a factor in simplifying contracts.

The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide - behind the US and UK - in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location's clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations - the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3]. The parties concerned share the conviction that, against the backdrops described, it would be helpful if the potential contract partners had access to recommendations that offer examples of constantly recurring cost positions in order to more precisely determine remuneration related to the conduct of a clinical trial. This article explains how the "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3] were developed and provides an overview of their content.

Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial.

BACKGROUND: In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP. METHODS: For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11-18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0·75 kg/m(2)). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101. FINDINGS: Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment: 85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0·46 kg/m(2) in favour of DP (95% CI, -0·11 to 1·02; pnon-inferiority<0·0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged. INTERPRETATION: DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach. FUNDING: German Ministry for Education and Research.

INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial.

BACKGROUND: Binge eating disorder (BED) is a prevalent clinical eating disorder associated with increased psychopathology, psychiatric comorbidity, overweight and obesity, and increased health care costs. Since its inclusion in the DSM-IV, a few randomized controlled trials (RCTs) have suggested efficacy of book-based self-help interventions in the treatment of this disorder. However, evidence from larger RCTs is needed. Delivery of self-help through new technologies such as the internet should be investigated in particular, as these approaches have the potential to be more interactive and thus more attractive to patients than book-based approaches. This study will evaluate the efficacy of an internet-based guided self-help program (GSH-I) and cognitive-behavioral therapy (CBT), which has been proven in several studies to be the gold standard treatment for BED, in a prospective multicenter randomized trial. METHODS: The study assumes the noninferiority of GSH-I compared to CBT. Both treatments lasted 4 months, and maintenance of outcome will be assessed 6 and 18 months after the end of treatment. A total of 175 patients with BED and a body mass index between 27 and 40 kg/m2 were randomized at 7 centers in Germany and Switzerland. A 20% attrition rate was assumed. As in most BED treatment trials, the difference in the number of binge eating days over the past 28 days is the primary outcome variable. Secondary outcome measures include the specific eating disorder psychopathology, general psychopathology, body weight, quality of life, and self-esteem. Predictors and moderators of treatment outcome will be determined, and the cost-effectiveness of both treatment conditions will be evaluated. RESULTS: The methodology for the INTERBED study has been detailed. CONCLUSIONS: Although there is evidence that CBT is the first-line treatment for BED, it is not widely available. As BED is still a recent diagnostic category, many cases likely remain undiagnosed, and a large number of patients either receive delayed treatment or never get adequate treatment. A multicenter efficacy trial will give insight into the efficacy of a new internet-based guided self-help program and will allow a direct comparison to the evidence-based gold standard treatment of CBT in Germany. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40484777. German Clinical Trial Register DRKS00000409.