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Plain English summary Early treatment contributes to a more favorable illness course and an improved prognosis in patients with anorexia nervosa (AN). The current study presents the development of the FABIANA checklist, which aims to assess factors which influence duration of untreated illness. The FABIANA checklist was developed on the basis of interviews with patients, their relatives and primary care practitioners. It provides data from the first use of the checklist in a German sample of 75 patients with AN. The results of our study suggest that the FABIANA-checklist is a valid instrument to assess factors involved in the process of treatment initiation. Emotional and practical support from the primary health care system and close relatives were the most consistent components. A follow-up study will investigate the relationship between the FABIANA-items and the DUI in order to guide the conception of effective secondary prevention measures.

Abstract Background An early psychotherapeutic treatment of anorexia nervosa (AN) is crucial for a good prognosis. In order to improve treatment initiation, knowledge about facilitators and barriers to treatment is needed. Objective Against this background, we aimed to identify facilitators and barriers from the perspectives of patients, carers and professionals using a qualitative approach. Method To this end, semi-structured interviews were conducted in triads of female patients with AN aged 14 years and older at the beginning of their first psychotherapeutic treatment, their carers, and referring health care professionals. A modified Grounded Theory approach was used for analysis. Results In total, 22 interviews were conducted (n = 6 adults, n = 4 adolescents, 4 full triads). The duration of untreated AN ranged between 30 days and 25.85 years (M = 3.06 ± 8.01 years). A wide spectrum of facilitators and barriers within the patient, the social environment, the health care system and the society were identified. Most prominent factors were ‘recognizing and addressing’ by close others, ‘waiting times and availability’ and ‘recommendations and referrals’ by health care professionals. ‘Positive role models for treatment’ were perceived as a specific facilitative social influence. Facilitators were more frequently mentioned than barriers and most of the factors seem to hold potential for modifiability. Conclusion Overall, the findings suggest that early intervention approaches for AN should not only address patients and the health care system, but may also involve carers and successfully treated former patients. Trial registration ClinicalTrials.gov Identifier: NCT03713541 .

Abstract Background Previous prevention programs in the school context have not addressed both genders, have been time-consuming, or have had deficits in the evaluation method. The aim of the present study was to evaluate the impact of a universal prevention program for female and male adolescents on eating disorder pathology and related risk factors. Methods Between February 2012 and July 2014, 2515 students in 23 schools from 8th or 11th grade were assessed for eligibility in this longitudinal cluster-randomized controlled trial with a six months follow-up. Of those students, 2342 were cluster-randomized to the intervention condition which received a six school hours universal prevention program or to the no treatment control condition. Results The complete case population comprised 724 students in the intervention (54.3% female, M = 14.3 years, SD = 1.61) and 728 in the control condition (57.0% female, M = 14.7 years, SD = 1.63). Random-effects analysis of covariance on the primary outcome showed no significant differences between the intervention and control groups in their eating disorder pathology change scores six months after the intervention. Regarding secondary outcomes, participants in the intervention group showed a greater increase in knowledge about eating disorders both after the intervention (p

BackgroundAnorexia nervosa is a serious disorder, which often takes a chronic course. Early treatment leads to a significantly better prognosis and prevents chronicity. However, existing evidence on facilitators and barriers in anorexia nervosa treatment initiation is scarce.AimsAgainst this background, the FABIANA study (ClinicalTrials.gov Identifier: NCT03713541) aims to (a) identify potentially modifiable facilitators and barriers from the perspectives of adolescent and adult patients with anorexia nervosa, carers and physicians, (b) develop and test an instrument for the combined assessment of multiple key facilitators and barriers, and (c) quantify the effect of potentially modifiable versus non-modifiable key facilitators and barriers on the duration of untreated illness (DUI) in patients with anorexia nervosa.MethodFABIANA is an observational, mixed-method-study divided into three consecutive substudies each corresponding to one of the study aims. All three substudies will include female patients with anorexia nervosa aged 14 years and older at the beginning of their first psychotherapeutic anorexia nervosa treatment. The qualitative substudy I and the quantitative substudy III will additionally include carers and involved physicians. The recruitment will take place at 20 cooperating study centres throughout Germany, which provide in-patient or out-patient anorexia nervosa specialist care. The DUI will be calculated based on the month of illness onset as determined in validated interviews on lifetime anorexia nervosa symptoms and the therapist-reported date of treatment initiation.ConclusionsStrengths and limitations of the retrospective assessment of the DUI will be discussed. The findings of the FABIANA study will contribute to the development of evidence-based early-intervention approaches and the prevention of a chronic course of illness.Trial registrationClinicalTrials.gov Identifier: NCT03713541.Declaration of interestNone.

After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear.A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied.At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal by the Stasi. The Stasi was not particularly interested in medico-ethical questions.Clinical trials conducted during the GDR period were surveilled by the Stasi. It was their aim to monitor all people involved in the trials, including their Western contacts. Relevant medico-ethical questions like patient consent and safety with respect to the clinical trials were not the focus. Considering the significant number of conducted trials, only limited evidence exists of doctors having discussed them critically. The public was not officially informed about the trials.

Psychotherapy is commonly described as a “talking cure,” a treatment method that operates through linguistic action and interaction. The operative specifics of therapeutic language use, however, are insufficiently understood, mainly due to a multitude of disparate approaches that advance different notions of what “talking” means and what “cure” implies in the respective context. Accordingly, a clarification of the basic theoretical structure of “talking cure models,” i.e., models that describe therapeutic processes with a focus on language use, is a desideratum of language-oriented psychotherapy research. Against this background the present paper suggests a theoretical framework of analysis which distinguishes four basic components of “talking cure models”: (1) a foundational theory (which suggests how linguistic activity can affect and transform human experience), (2) an experiential problem state (which defines the problem or pathology of the patient), (3) a curative linguistic activity (which defines linguistic activities that are supposed to effectuate a curative transformation of the experiential problem state), and (4) a change mechanism (which defines the processes and effects involved in such transformations). The purpose of the framework is to establish a terminological foundation that allows for systematically reconstructing basic properties and operative mechanisms of “talking cure models.” To demonstrate the applicability and utility of the framework, five distinct “talking cure models” which spell out the details of curative “talking” processes in terms of (1) catharsis, (2) symbolization, (3) narrative, (4) metaphor, and (5) neurocognitive inhibition are introduced and discussed in terms of the framework components. In summary, we hope that our framework will prove useful for the objective of clarifying the theoretical underpinnings of language-oriented psychotherapy research and help to establish a more comprehensive understanding of how curative language use contributes to the process of therapeutic change.

Knowing which specific verbal techniques "good" therapists use in their daily work is important for training and evaluation purposes. In order to systematize what is being practiced in the field, our aim was to empirically identify verbal techniques applied in psychodynamic sessions and to differentiate them according to their basic semantic features using a bottom-up, qualitative approach.Mixed-Method-Design: In a comprehensive qualitative study, types of techniques were identified at the level of utterances based on transcribed psychodynamic therapy sessions using Qualitative Content Analysis (4211 utterances). The definitions of the identified categories were successively refined and modified until saturation was achieved. In a subsequent quantitative study, inter-rater reliability was assessed both at the level of utterances (n = 8717) and at the session level (n = 38). The convergent validity of the categories was investigated by analyzing associations with the Interpretive and Supportive Technique Scale (ISTS).The inductive approach resulted in a classification system with 37 categories (Psychodynamic Interventions List, PIL). According to their semantic content, the categories can be allocated to three dimensions: form (24 categories), thematic content (9) and temporal focus (4). Most categories showed good or excellent inter-rater reliability and expected associations with the ISTS were predominantly confirmed. The rare use of the residual category "Other" suggests that the identified categories might comprehensively describe the breadth of applied techniques.The atheoretical orientation and the clear focus on overt linguistic features should enable the PIL to be used without intensive training or prior theoretical knowledge. The PIL can be used to investigate the links between verbal techniques derived from practice and micro-outcomes (at the session level) as well as the overall therapeutic outcomes. This approach might enable us to determine to what extent the outcome of therapy is due to unintended or non-theoretically relevant techniques.