Do the elderly and those with comorbid chronic physical conditions have improved access to outpatient psychotherapy post structural reforms in Germany? Results of the ES-RiP study.

Background: In 2017, a reform of the German outpatient psychotherapy guideline was carried out, aiming to reduce waiting times and facilitate low-threshold access. This study analyzes the extent to which the implementation of the two new service elements 'psychotherapeutic consultation times' and 'acute short-term psychotherapeutic interventions' improved psychotherapeutic care for patients with mental disorders and chronic physical conditions (cMPs), for patients with mental disorders without chronic physical conditions (MnoP), and elderly patients. Methods: In a quantitative secondary analysis, we analyzed health insurance data of patients with psychotherapy billing codes obtained from the National Association of Statutory Health Insurance Physicians (KBV) for the years 2015-2019, evaluating descriptive statistical parameters for specific patient groups and care services. Results: Between 2015 and 2019, the number of mentally ill receiving psychotherapy at least once in the corresponding year increased by 30.7%. Among these, the proportion of cMPs-patients increased from 26.8% to 28.2% (+1.4%), while that of MnoP-patients decreased from 68.3% to 66.4% (-1.9%). The number of elderly people receiving treatment also increased. Conclusion: Since increases and decreases in the percentage shares occur evenly over the years investigated, it is questionable whether the reform in 2017 has had a direct influence on these changes. Study registration: ID DRKS00020344, URL: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html.

Outpatient Psychotherapy in Germany­An Evaluation of the Structural Reform.

BACKGROUND: A structural reform of the German psychotherapy guideline in 2017 was intended to facilitate access to outpatient guideline psychotherapy. In the present study, we evaluate the effects of this reform in particular for patients a comorbidity of mental disorders and chronic physical conditions (cMP). METHODS: Pre-post analyses of the two primary endpoints "percentage of mentally ill persons who have made an initial contact with a psychotherapist" and "waiting time for guideline psychotherapy" were carried out employing population-based and weighted routine statutory health insurance data from the German BARMER. The secondary endpoints included evaluations from the patients' perspective, based on a representative survey of patients in psychotherapy, and an overview of the health care situation based on data from the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (study registration number: DRKS00020344). RESULTS: From 2015 to 2018, the percentage of mentally ill persons who had made an initial contact with a psychotherapist rose moderately, from 3.7% (95% confidence interval, [3.6; 3.7]) to 3.9% [3.8; 3.9] among persons with cMP and from 7.3% [7.2; 7.4] to 7.6% [7.5; 7.7] among those with mental disorders but without any chronic phyisical condition (MnoP). The new structural elements were integrated into patient care. The interval of time between the initial contact and the beginning of guideline psychotherapy became longer in both groups, from a mean of 80.6 [79.4; 81.8] to 114.8 [113.4; 116.2] days among persons with complex disease and from 80.2 [79.2; 81.3] to 109.6 [108.4; 111.0] days among persons with non-complex disease; most patients considered the waiting time. Approximately 8% of the patients who sought psychotherapy reported that they had not obtained access to a psychotherapist. CONCLUSION: Neither in general nor for patients with cMP did the introduction of the structural reform appreciably lower the access barriers to psychotherapy. Further steps are needed so that outpatient care can meet the needs of all patients and particularly those with cMP.

Effect of the addition of a mental health specialist for evaluation of undiagnosed patients in centres for rare diseases (ZSE-DUO): a prospective, controlled trial with a two-phase cohort design.

Background: People with complex symptomatology but unclear diagnosis presenting to a centre for rare diseases (CRD) may present with mental (co-)morbidity. We hypothesised that combining an expert in somatic medicine with a mental health specialist working in tandem will improve the diagnostic outcome. Methods: Patients aged 12 years and older who presented to one of the 11 participating German CRDs with an unknown diagnosis were recruited into this prospective cohort trial with a two-phase cohort design. From October 1, 2018 to September 30, 2019, participants were allocated to standard care (SC, N = 684), and from October 1, 2019 to January 31, 2021 to innovative care (IC, N = 695). The cohorts consisted mainly of adult participants with only a minority of children included (N = 67). IC included the involvement of a mental health specialist in all aspects of care (e.g., assessing medical records, clinic visits, telehealth care, and case conferences). Clinicaltrials.gov identifier: NCT03563677. Findings: The proportion of patients with diagnoses established within 12 months after the first visit to the CRD explaining the entire symptomatology (primary outcome) was 19% (N = 131 of 672) in the SC and 42% (N = 286 of 686) in the IC cohort (OR adjusted for centre effects 3.45 [95% CrI: 1.99-5.65]). The difference was mainly due to a higher prevalence of mental disorders and non-rare somatic diseases in the IC cohort. The median time to explaining diagnoses was one month shorter with IC (95% CrI: 1-2), and significantly more patients could be referred to local regular care in the IC (27.5%; N = 181 of 659) compared to the SC (12.3%; N = 81 of 658) cohort (OR adjusted for centre effects 2.70 [95% CrI: 2.02-3.60]). At 12-month follow-up, patient satisfaction with care was significantly higher in the IC compared to the SC cohort, while quality of life was not different between cohorts. Interpretation: Our findings suggested that including a mental health specialist in the entire evaluation process of CRDs for undiagnosed adolescents and adults should become an integral part of the assessment of individuals with a suspected rare disease. Funding: The study was funded by the Global Innovation Fund from the Joint Federal Committee in Germany (Innovationsfonds des Gemeinsamen Bundesausschusses), grant number 01NVF17031.

Psychometric properties and normative values of the revised demoralization scale (DS-II) in a representative sample of the German general population.

BACKGROUND: Demoralization is a clinically relevant syndrome in chronic diseases. The demoralization scale (DS-II) was recently developed as an economic screening tool in clinical populations. Main aim of this study was to provide normative data of DS-II scores in the general population. METHODS: We developed a new German version, the DS-II Münster, and tested internal consistency as well as the previously proposed two-factor structure with confirmatory factor analyses. The DS-II was applied in a household survey of the general population. Associations between DS-II scores and age, gender and other sociodemographic variables were explored. RESULTS: The final sample consisted of N = 2471 participants (mean age = 49.8 years, range: 18-96; 50.1% men, 49.8% women). The DS-II Münster showed nearly excellent internal consistency. The model fit indices of the two-factor structure were not superior to those of the one-factor model. Mean scores of the DS-II were as follows. Total score: M = 3.76 (SD = 5.56), Meaning and Purpose subscale: M = 1.65 (SD = 2.77), Distress and Coping Ability subscale: M = 2.11 (SD = 3.02). DS-II scores were increased in women with an effect size of Cohen's d = 0.19. An age-related increase was specifically found for the Meaning and Purpose subscale (d = 0.21). CONCLUSIONS: The study provides normative values of the DS-II with respect to age and gender in the general population to facilitate interpretation of DS-II scores in clinical samples. A DS-II total score > 5 is suggested as a cut-off value. The findings further our understanding of significant symptom burden that was previously suggested in young patients with cancer.

Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.

BACKGROUND: In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process. STUDY DESIGN: This multi-center, prospective controlled study has a two-phase cohort design. METHODS: Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD's outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2). OUTCOMES: Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients' quality of life and evaluation of care; and f) physicians' satisfaction with the innovative care approach. CONCLUSIONS: This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease. Trial registration ClinicalTrials.gov; Identifier: NCT03563677; First posted: June 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03563677 .

Evaluating effects of the structural reform of outpatient psychotherapy for patients with mental disorders in Germany: comparing patients with and without comorbid chronic physical condition - rationale and study protocol of the ES-RiP project.

INTRODUCTION: In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists' availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy. METHODS AND ANALYSIS: A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives. ETHICS AND DISSEMINATION: Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg - Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020344.

Evaluating the structural reform of outpatient psychotherapy in Germany (ES-RiP trial) - a qualitative study of provider perspectives.

BACKGROUND: Access to outpatient mental healthcare can be challenging for patients. In Germany, a national structural reform was implemented in 2017 to accelerate and enhance access to outpatient psychotherapy and reduce waiting times. During the first phase of the study 'Evaluation of a structural reform of the outpatient psychotherapy guideline (ES-RiP)' and embedded into a process evaluation, the implementation was to be evaluated through assessing general practitioners' (GPs) and psychotherapists' (PTs) perspectives regarding utilization of provided new measures, and perceived potential for optimization. Particular focus was on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs). METHODS: This exploratory cross-sectional qualitative study used on-site and online focus group discussions and semi-structured telephone interviews with GPs and outpatient PTs. Generated data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze participant characteristics collected via a socio-demographic questionnaire. RESULTS: Perspectives on the structural reform were heterogenous. GPs and PTs considered the component of timely initial psychotherapeutic assessment consultations beneficial. GPs disapproved of their deficits in detailed information about the structural reform and exchange with outpatient PTs. Improvement suggestions included structured short information exchange and joint quality circles. The overall number of available outpatient PTs in rural areas was perceived as insufficient. For patients with cMPs, GPs saw patient barriers for therapy access and continuity in low intrinsic motivation, physical impediments and older age. PTs also saw patient challenges regarding low intrinsic motivation and keeping scheduled appointments. They considered post-reform administrative efforts to be high and reported that the regulations (conformity) lead to planning difficulties and financial losses. Reform elements were tailored to fit in with PTs key therapy areas. Stronger networking and joint lectures were suggested as remedy for the currently still limited exchange with GPs. Unlike the GPs, PTs emphasized that accepting patients into psychotherapeutic treatment was independent of a possibly present chronic physical disease. CONCLUSIONS: The findings contribute to understanding the integration of the delivered structural reform into daily care processes and provide an indication about reached targets and potential improvements. Further phases of the ES-RiP study can build on the findings and broaden insights. TRIAL REGISTRATION: Registration-ID DRKS00020344 (DRKS German Register of Clinical Trials.

[Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model]. / Behandlungscluster und Personalbemessung in der psychosomatischen Medizin und Psychotherapie ­ Ergebnisse einer Machbarkeitsstudie zum Plattformmodell.

Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model Objectives: In accordance with the legal requirements of the PsychVVG, it is necessary to develop criteria for inpatient and day-care psychosomatic psychotherapeutic care, which can be used to determine the appropriate staffing for different treatment areas and different care structures. For psychosomatic medicine and psychotherapy a model with four treatment clusters was developed, which is oriented on the one hand to the psychotherapeutic intensity and on the other hand to the medical expenditure. Method: In three consecutive rounds with up to 30 experts, representative selected from the three institution types university hospital, departmental psychosomatic medicine and specialized clinic, the minute values per patient required for a treatment according to the guidelines were determined using the Delphi method. Newly developed activity profiles for the six occupational groups were used, which allow the recording of all patient- and setting-related activities. Results: With the results of the feasibility study, an instrument has been developed for the first time to determine the requirements of staffing in psychosomatic medicine. Convergent minute values could be formulated for three of the four treatment clusters. Conclusions: The provision of care in psychosomatic medicine and psychotherapy is complex, so that a limitation to four treatment areas is only possible if significantly more generous equivalence rules are applied between the professional groups than those laid down in the PPP Directive.

Individual and Needs-Based: The Platform-Model for Personnel Allocation in Child and Adolescent Psychiatry and Psychotherapy.

Objective: An initiative by scientific societies of psychiatry, child and adolescent psychiatry, psychosomatic medicine, and further associations established the Platform-Model for the development of a needs-based system for adequate personnel allocation in psychiatric inpatient and day clinic units. We present the development of the instrument and a pilot study to identify feasibility and limitations. Methods: The basis of the study was a threefold methodological approach. Paradigmatic case vignettes adequately reflecting symptomatology and circumstances were described and validated, working profiles were generated and validated, and a matrix representing different needs-based dimensions was developed. Through reference date surveys, patients were assigned to needs-based clusters and Psych-PV categories. The required treatment effort under consideration of guidelines or expert consensus was estimated in several rounds of expert panels (Delphi method). Results: The pilot study proves the feasibility of the Platform-Model. Methodological findings as well as limitations of the model were identified in order to further develop the Platform-Model. Conclusions: The Platform-Model cannot serve as a tool to describe clinical pathways, but it appears to be an adequate and practical tool for assessment of the required staffing level based on patient needs independent of diagnosis and setting.

[Increased attention of radiotherapy patients to religiousness and spirituality - a comparison with patients in a psychosomatic outpatient clinic]. / Erhöhte Hinwendung von Strahlentherapiepatienten zu Religiosität und Spiritualität ­ ein Vergleich mit Patienten einer psychosomatischen Ambulanz.

Increased attention of radiotherapy patients to religiousness and spirituality - a comparison with patients in a psychosomatic outpatient clinic Objectives: The aim of this study is to prove both hypothesis, that patients of radiation therapy are different to patients of a psychosomatic outpatient unit in case of their spirituality and religiosity and that these attitudes have an influence of their own lives. Methods: In a cross-sectional study, a data set of the Department of Psychosomatic and Psychotherapy of the University Hospital Münster in 2013 (n = 1110) was compared to data from 2017 by the Department of Radiation Therapy - Radiation oncology of the University Münster (n = 275) in terms of their religiosity and spirituality. The survey was carried out by a questionnaire on religious attitudes (FRA-RE, Heuft 2016). An age- and gender-controlled statistical analysis has been made by means of partial correlations and mean comparisons. Results: The results are consistent with the hypothesis that patients of radiotherapy, in contrast to psychosomatic patients, are more religious, more spiritual, show more private, but also public religious/spiritual practice, have a stronger desire for more religiosity in their lives and belief that religiosity helps to overcome times of crisis. Conclusions: Thus, it is of particular importance to provide this burdened patient clientele spiritual/religious offers for coping with their disease.

Criteria Suggestive of Psychological Components of Itch and Soma-toform Itch: Study of a Large Sample of Patients with Chronic Pruritus.

While psychological factors are relevant in many patients with chronic pruritus, not all patients can be offered psychologic, psychosomatic or psychiatric consultation. The aim of this exploratory study was to identify criteria suggestive of psychological factors relevant for the etiology of chronic pruritus and of somatoform pruritus. Routine data from the database of the Center for Chronic Pruritus of the University Hospital Münster were used, including the Neuroderm Questionnaire, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale. Chronic pruritus patients (n = 3,391) without a psychiatric diagnosis in their medical history were compared to the 331 chronic pruritus patients with diagnoses of "psychological factors associated with etiology and course of chronic pruritus" (ICD-10:F54) or "somatoform pruritus" (F45.8) confirmed by an expert. The latter reported more pruritus triggers, especially "strain" and "emotional tension" and used more emotional adjectives to describe their pruritus. They reported more often scratching leading to excoriations, higher levels of pruritus, impairment of quality of life, anxiety and depression. These aspects suggest the presence of psychological factors in the etiology of chronic pruritus and somatoform pruritus. Prospective validation, however, needs to be carried out.

Psychosomatische Institutsambulanzen (PsIA) ­ und (k)ein Ende. Ein guter Anfang, der nun weiterentwickelt werden will.

The objective of this paper is to describe the agreement from the perspective of the authors who, as experts for the Deutsche Krankenhausgesellschaft (DKG - German Hospital Federation), have accompanied the PsIA negotiations since 2013. It traces the development of the PsIA negotiations leading to the "Änderungsvereinbarungen zur Vereinbarung zu den Psychiatrischen Institutsambulanzen gemäß § 118 Abs. 2 SGB V" (amendment agreements to the Agreement concerning the Psychiatric Outpatient Departments according to § 118 Abs. 2 SGB V - German Social Security Statute Book) of October 2019 with its striking difficulties in view of partly diametrally opposed interests of the negotiating partners.

[Level of personality functioning (OPD-2) and the symptom severity of posttraumatic stress disorder - a cohort study]. / Steht das strukturelle Integrationsniveau nach OPD-2 in Zusammenhang mit der Symptomschwere einer Posttraumatischen Belastungsstörung (PTBS)? ­ Eine Kohortenstudie bei Patienten einer Trauma-Ambulanz.

Level of personality functioning (OPD-2) and the symptom severity of posttraumatic stress disorder - a cohort study Objectives: To investigate the affirmed correlation between the level of personality functioning (OPD-2, Axis IV "Structure") and the symptom severity of posttraumatic stress disorder based on clinical routine data was the main goal of this study. Method: Cross-sectional data was acquired between 2013 and 2016 using random samples of standardized questionnaires in the trauma outpatient clinic of the Department of Psychosomatics and Psychotherapy, University Hospital in Münster, Germany. The German version of the PDS (Ehlers et al. 1996) measured the symptoms and the severity of PTSD, level of personality functioning was assessed by the OPD-SFK (Ehrenthal et al. 2015) Results: Level of personality functioning in OPD-SFK and the severity of posttraumatic symptoms are significantly correlated to each other. The less the functioning of the psychic structure the more the symptom severity shows up. The results were confirmed with different sets of predictors in our statistical models. Conclusions: The level of the personality functioning (OPD-2) is related to the severity of posttraumatic symptoms. Whether a low-level personality functioning is a disposal for PTSD or more likely a result of a traumatic life event, should be discussed.

[Psychometric Properties of the Shortend Version of the "Systems of Belief Inventory" in a Representative Sample of the German Population]. / Psychometrische Überprüfung der Kurzversion des "Systems of Belief Inventory" in einer deutschlandweiten repräsentativen Bevölkerungsstichprobe.

INTRODUCTION: The aim of the present study was to show the development of the revised and shortened German version (6 items) of the "Systems of Belief Inventory" (SBI-6R-D) as well as to examine its psychometric properties. METHODS: In a representative German sample the questionnaire has been given to 2513 subjects. A confirmatory factor analysis has been made to prove the original American factor structure. Measurement invariance was tested using multigroup analysis. Correlations were used to determine convergent and discriminant validity towards other items. RESULTS: The SBI-6R-D showed good item and scale characteristics as well as good model fit. In difference to the work of Albani et al. (SBI-15R-D), the 2 factorial structure of the original American questionnaire could be replicated. Scalar invariance could be shown for gender and age, metric invariance for denomination and federal state. DISCUSSION: Due to the good psychometric properties of the questionnaire it should be further analyzed in future research with other validated religious instruments. CONCLUSIONS: The new German short version, the SBI-6R-D, is an economic, reliable and valid questionnaire to measure spiritual and religious attitudes.

[Psychometric Properties of the Shortend Version of the Scale "Transpersonal Trust" in a Representative Sample of the German Population]. / Psychometrische Überprüfung der Kurzversion der Skala "Transpersonales Vertrauen" in einer deutschlandweiten repräsentativen Bevölkerungsstichprobe.

INTRODUCTION: The aim of the present study was to show the development of the revised and shortened German version (6 items) of the scale "Transpersonales Vertrauen" (TPV-6R; 2017) as well as to examine its psychometric properties. METHODS: In a representative German sample the questionnaire has been given to 2513 subjects. Collected data from 2464 subjects could be analysed. Exploratory and confirmatory factor analysis has been made to prove the original one-factor model (Belschner, 2000) as well as the 2-factorial structure found by Albani et al. (2003). Measurement invariance was tested using multigroup analysis. Correlations were used to determine convergent and discriminant validity towards other items. RESULTS: After excluding 2 items due to their unsatisfactory scale fit, the 4 item model showed good item and scale characteristics as well as excellent model fit. The one factorial structure of the original work of Belschner and colleagues (2000) could be replicated. Metric invariance could be shown for gender and age, partial scalar invariance could be only generated for gender. No metric or scalar invariance could be shown for federal state and denomination. DISCUSSION: Due to the good psychometric properties of the TPV-4R questionnaire it should be further analyzed in future research with other validated instruments that are measuring spiritual or religious attitudes. CONCLUSIONS: The new German short version, the TPV-4R, is an economic, reliable and valid questionnaire to measure spiritual attitudes.