BACKGROUND:Medically complex inpatients with severe somatic illness and comorbid mental disorders are rarely reached by standard psychiatric or psychosomatic services due to physical limitations and complex care needs. The Nuremberg Integrated Psychosomatic Acute Unit (NIPA)-an embedded, ward-based psychosomatic care model delivering multidisciplinary treatment-was developed to address this gap by providing proactive, individualized psychosomatic care directly within internal medicine wards. OBJECTIVE:To describe symptom trajectories and hospitalization patterns associated with participation in the NIPA model under real-world conditions. METHODS:We analyzed real-world clinical data from a retrospective cohort of 139 patients with gastrointestinal, respiratory, and oncological diseases treated by NIPA between 2018 and 2024. Depression (Patient Health Questionnaire 9), anxiety (Generalized Anxiety Disorder 7), and somatic symptom burden (Patient Health Questionnaire 15) were assessed at admission and discharge. Patient satisfaction was assessed using the Nuremberg Satisfaction with Treatement Questionnaire (ZUF-8). A postal follow-up survey was conducted 3 months postdischarge (response rate 25.2%). Hospitalization data for the 3 months before and after NIPA were obtained from hospital records and supplemented by follow-up self-reports. RESULTS:Statistically significant improvements in depression (η2 = 0.30), anxiety (η2 = 0.37), and somatic symptoms (η2 = 0.19) were observed at discharge. At 3-month follow-up, sustained improvements were observed for anxiety (η2 = 0.36) and moderate improvements for depression (η2 = 0.17). Within 3 months of discharge, 26.2% of patients were rehospitalized; in only 8.2% of cases was readmission associated with the same psychosocial symptom constellation. Most readmissions were attributable to somatic deterioration or planned medical interventions. Among patients with frequent prior hospitalizations, mean inpatient days were observed to decrease from 8.4 to 3.2, and 64.6% were not readmitted. CONCLUSIONS:Participation in the NIPA program was associated with clinically meaningful improvements in psychological distress and favorable hospitalization patterns among medically complex inpatients. These findings suggest that this kind of integrated proactive psychosomatic care is feasible for this underserved population and support the need for controlled studies to further evaluate its effectiveness.
IntroductionCancer-related fatigue (CRF) is a common symptom of cancer and/or its treatment. Most cancer patients are affected during treatment, as well as years thereafter. Around a third of survivors report suffering from CRF. Those affected are often restricted in their everyday life. Acute and chronic stress are factors that increase a person’s vulnerability to develop CRF. In previous studies different instruments measuring acute and chronic stress related to CRF were used. However, a global instrument to determine individual stress load is lacking.MethodsTherefore, a developed global stress index (GSI) combining specific measuring instruments for acute and chronic stress is validated on an oncological sample and its influence on fatigue is examined. It is hypothesized that individuals with a high global stress load measured by the GSI report higher levels of CRF. The data will be collected using questionnaires in participants suffering from breast cancer with a curative treatment approach. Participants will be surveyed during tumor-specific therapy and six months later. They receive a consultation if fatigue symptoms are strongly pronounced. The study is registered at Deutsches Register Klinischer Studien, no. DRKS DRKS00027864.DiscussionThis will be the first study using the GSI as a valid measure for surveying longitudinally acute and chronic stress load in an oncological sample in relation to CRF symptom development. The GSI may help to identify tumor patients with high levels of stress in good time and thus prevent chronic fatigue.
Einleitung: Erstmalig wurde im Mai 2008 in Freiburg ein Curriculum Konsiliar- und Liaisondienst von der AG Konsiliar-Liaison-Psychosomatik des DKPM, der DGPM und der AG Konsiliarpsychiatrie der DGPPN gemeinsam angeboten. Das Curriculum richtet sich an Ärzte in Weiterbildung zum Facharzt für Psychosomatische Medizin und Psychotherapie bzw. zum Facharzt für Psychiatrie und Psychotherapie sowie an Ärzte mit der Zusatzweiterbildung Psychotherapie und an Psychologen mit klinischer Tätigkeit. Methodik: Zu den Lernzielen gehört die Befähigung zur Arbeit im psychologischen, psychiatrischen, psychosomatischen, psychosozialen oder psychotherapeutischen Konsiliar- und Liaisondienst (Diagnostik, therapeutische Interventionen, Kooperation) und Aspekte der Qualitätssicherung. Die Kompetenzen wurden in einer Mischung aus Kurzvorträgen, Rollenspielen, Hospitationen und Fallsupervisionen vermittelt. Auf Praxiserfahrungen der Teilnehmer wurde explizit eingegangen. Ergebnisse:Überraschend setze sich der erste Kurs aus 20 zum Teil sehr erfahrenen Kollegen mit abgeschlossener Facharztausbildung bzw. Approbation zusammen, die überwiegend bereits im Konsiliar- und Liaisondienst arbeiteten. Das Curriculum wurde von den Teilnehmern sehr positiv evaluiert: Sie schätzten besonders den praxisorientierten Ansatz sowie die konsilspezifischen Beiträge der verschiedenen Dozenten. Der positive Start ermutigt zur Weiterführung. Das nächste Curriculum findet im Juni 2009 in Dresden statt.
Cell therapies, including tumor antigen-loaded dendritic cells used as therapeutic cancer vaccines, offer treatment options for patients with malignancies. We evaluated the feasibility, safety, immunogenicity, and clinical activity of adjuvant vaccination with Wilms’ tumor protein (WT1) mRNA-electroporated autologous dendritic cells (WT1-mRNA/DC) in a single-arm phase I/II clinical study of patients with advanced solid tumors receiving standard therapy. Disease status and immune reactivity were evaluated after 8 weeks and 6 months. WT1-mRNA/DC vaccination was feasible in all patients, except one. Vaccination was well tolerated without evidence of systemic toxicity. The disease control rate and overall response rate among a total of 39 evaluable patients were 74.4
OBJECTIVE:Impairment in personality functioning (PF) has been linked to a number of mental disorders, including eating disorders (EDs). However, the precise relationship between PF and symptom severity, as well as the potential impact on outcome, remains unclear. The study aimed to analyse the association of PF and its change with severity of ED symptomatology as well as outcome of hospital treatment. METHOD:The sample consisted of 397 patients with EDs, treated in 19 university hospitals for Psychosomatic Medicine and Psychotherapy in Germany between 1/2019 and 12/2020. PF was measured with the Structure Questionnaire of the Operationalised Psychodynamic Diagnosis (OPD-SQ, short version), eating psychopathology with the ED examination questionnaire (EDE-Q). Outcome was defined as a change in the EDE-Q total score. We used Latent Change Score Modelling to analyse changes in ED pathology during treatment and a 1-year follow-up period. RESULTS:A higher level of impairment in PF at admission correlated with more eating psychopathology and a less favourable outcome. Additionally, greater improvement in PF correlated with greater improvements in ED symptomatology at discharge. CONCLUSION:Impairment in PF needs to be part of diagnostic assessments and should be considered an important treatment target for psychotherapeutic interventions. TRIAL REGISTRATION:The MEPP study was registered in the German Clinical Trials Register (DRKS, www.drks.de; ID: DRKS00016412).
Miscarriage (MC) and stillbirth (SB) can be considered as potentially traumatic events (PTE) and affect approximately 10–20
BackgroundThere is a lack of reliable data concerning the long-term effectiveness of psychosomatic inpatient and day hospital treatment in a naturalistic setting. The Multicenter Effectiveness Study of Inpatient and Day Hospital Treatment in Departments of Psychosomatic Medicine and Psychotherapy in Germany aims to provide such data. The study itself and effectiveness from admission to discharge have already been reported in this journal (Doering et al., 2023). This brief report adds 12-month follow-up data.MethodsThe relevant outcome variables concerning somatoform, trauma-related, eating and personality disorders, as well as anxiety and depressive disorders were assessed by means of questionnaires on admission (T0), at discharge (T1) and after 12 months (T2). In order to make targeted statements about effectiveness regarding only clinically relevant symptoms, each symptom domain was stratified by severity at admission.ResultsFrom a total of 2,094 patients at admission, 60.6% still provided data at T2. Overall, the changes achieved at discharge (T1) already reported in Doering (2023) remained stable over the 12-month follow-up period (T2). There were hence significant improvements from T0 to T2 across all symptom domains with large effect sizes ranging from d=1.0 to 3.4.ConclusionsThe already reported effectiveness of inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy in a naturalistic setting is further strengthened by providing evidence for sustained treatment effects over the 12-month follow-up period. Importantly, the entire spectrum of disorders investigated showed this pattern.Clinical Trial Registrationhttps://drks.de/search/de/trial/DRKS00016412 RKS00016412, identifier DRKS00016412.
INTRODUCTION:Communication training (CT) enhances the communication skills of oncology healthcare professionals. Kommunikative Kompetenz und Performanz in der Arzt-Patient Beziehung fördern (KPAP; fostering communicative competence and performance of physician-patient relation) is an intervention study that evaluates the long-term effects 3 years after the CTs in the context of a CT programme. It is supported by the German Cancer Aid and conducted at the University Hospital of Cologne. METHODS:The aim of the study will be to assess the long-term communicative competence of physicians using a multimodal approach through self-assessment and external evaluation by trained experts and trained patient raters. Prior to the study, physicians working with cancer patients underwent a structured CT. Self-reported questionnaires were completed at the beginning (T0), at the end (T1) of the 2.5-day CT, and during a 6-h refresher session (T2) several months later. Participants were recorded on video while breaking bad news (BBN) to standardised patients. As part of this study, participants will complete self-reported questionnaires at least 3 years after the 2.5-day CT (T3). At T3, a subsample of participants (at least n = 60) will be video-recorded again. These simulated BBN encounters at T0 and T3 will be rated by trained patient raters and trained experts using the Bad News Consultation Assessment Scale (AGBS) and the Consultation and Relational Empathy instrument. The primary outcome will be the difference between AGBS scores at T3 and T0. Furthermore, expert raters will analyse these videos using Discourse Coding Analysis Software and the ComOn Rating Scale. Additionally, the health literacy of patient raters will be assessed using the European Health Literacy Survey (HLS-EU). CONCLUSION:A more precise understanding of communicative competences, particularly by incorporating the patient's perspective, will enable the development of recommendations for future training and enhance the sustainability of CT.
Patient-reported outcomes (PROs) offer a diverse array of potential applications within medical research and clinical practice. In comparative research, they can serve as tools for delineating the trajectories of health-related quality of life (HRQoL) across various cancer types. We undertook a secondary data analysis of a cohort of 1498 hospitalized cancer patients from 13 German cancer centers. We assessed the Physical and Mental Component Scores (PCS and MCS) of the 12-Item Short-Form Health Survey at baseline (t0), 6 (t1), and 12 months (t2), using multivariable generalized linear regression models. At baseline, the mean PCS and MCS values for all cancer patients were 37.1 and 44.3 points, respectively. We observed a significant improvement in PCS at t2 and in MCS at t1. The most substantial and significant improvements were noted among patients with gynecological cancers. We found a number of significant differences between cancer types at baseline, t1, and t2, with skin cancer patients performing best across all time points and lung cancer patients performing the worst. MCS trajectories showed less pronounced changes and differences between cancer types. Comparative analyses of HRQoL scores across different cancer types may serve as a valuable tool for enhancing health literacy, both among the general public and among cancer patients themselves.
BACKGROUND:Clinical experiences using a psychosomatic-oriented multimodal treatment approach in patients with post-COVID are promising. We established a half-day multimodal treatment program for post-COVID patients at the Department of Psychosomatic Medicine at General Hospital Nuremberg, Paracelsus Medical University, Germany. METHODS:This observational study between January 2022 and March 2023 comprised baseline documentation of Patient Health Questionnaire (PHQD), ICD-10 Symptom Rating (ISR), Fatigue Scale (FS) and Health Status Questionnaire (SF-12) at admission and discharge of 65 patients suffering from post-COVID. Multimodal psychosomatic treatment was scheduled for 3-4 weeks. RESULTS:At admission, PHQ and FS showed a high level of somatic symptom burden (PHQ-15: M = 16.0, SD = 5.6) and fatigue symptoms (FS: M = 27.1, SD = 4.4). Depressive (PHQ-9: M = 14.0, SD = 5.3) and anxiety symptoms (GAD-7: M = 9.6, SD = 5.6) were moderately and mildly pronounced, respectively. Compared to patients from our standard clinical settings post-COVID patients had a comparably high or even higher mental symptom burden (e.g. PHQ-15: p < .001, d = 0.79; PHQ-9: p = .009, d = 0.39). Compared to admission, symptomatology of post-COVID patients at discharge was improved (e.g. PHQ-15: p = .004, d = 0.26; FS: p = .009, d = 0.32). CONCLUSIONS:Despite the short duration of treatment, the patients showed a significant reduction in symptoms between admission and discharge. Further data including a control group and extending the duration of treatment will show whether the changes in symptoms are of the multimodal psychosomatic treatment.
Introduction Diffuse intrinsic pontine glioma (DIPG) and paediatric high-grade glioma (pHGG) are aggressive glial tumours, for which conventional treatment modalities fall short. Dendritic cell (DC)-based immunotherapy is being investigated as a promising and safe adjuvant therapy. The Wilms’ tumour protein (WT1) is a potent target for this type of antigen-specific immunotherapy and is overexpressed in DIPG and pHGG. Based on this, we designed a non-randomised phase I/II trial, assessing the feasibility and safety ofWT1mRNA-loaded DC (WT1/DC) immunotherapy in combination with conventional treatment in pHGG and DIPG. Methods and analysis 10 paediatric patients with newly diagnosed or pretreated HGG or DIPG were treated according to the trial protocol. The trial protocol consists of leukapheresis of mononuclear cells, the manufacturing of autologous WT1/DC vaccines and the combination of WT1/DC-vaccine immunotherapy with conventional antiglioma treatment. In newly diagnosed patients, this comprises chemoradiation (oral temozolomide 90 mg/m2daily+radiotherapy 54 Gy in 1.8 Gy fractions) followed by three induction WT1/DC vaccines (8–10×106cells/vaccine) given on a weekly basis and a chemoimmunotherapy booster phase consisting of six 28-day cycles of oral temozolomide (150–200 mg/m2on days 1–5) and a WT1/DC vaccine on day 21. In pretreated patients, the induction and booster phase are combined with best possible antiglioma treatment at hand. Primary objectives are to assess the feasibility of the production of mRNA-electroporated WT1/DC vaccines in this patient population and to assess the safety and feasibility of combining conventional antiglioma treatment with the proposed immunotherapy. Secondary objectives are to investigate in vivo immunogenicity of WT1/DC vaccination and to assess disease-specific and general quality of life. Ethics and dissemination The ethics committee of the Antwerp University Hospital and the University of Antwerp granted ethics approval. Results of the clinical trial will be shared through publication in a peer-reviewed journal and presentations at conferences. Trial registration number NCT04911621
Malignant pleural mesothelioma (MPM) is an aggressive cancer with a very poor prognosis. Recently, immune checkpoint inhibition (ICI) has taken center stage in the currently ongoing revolution that is changing standard-of-care treatment for several malignancies, including MPM. As multiple arguments and accumulating lines of evidence are in support of the existence of a therapeutic synergism between chemotherapy and immunotherapy, as well as between different classes of immunotherapeutics, we designed a multicenter, single-arm, phase I/II trial in which both programmed-death-ligand 1 (PD-L1) inhibition and dendritic cell (DC) vaccination are integrated in the first-line conventional platinum/pemetrexed-based treatment scheme for epithelioid MPM patients (Immuno-MESODEC, ClinicalTrials.gov identifier NCT05765084). Fifteen treatment-naïve patients with unresectable epithelioid subtype MPM will be treated with four 3-weekly (±3 days) chemo-immunotherapy cycles. Standard-of-care chemotherapy consisting of cisplatinum (75mg/m2) and pemetrexed (500mg/m2) will be supplemented with the anti-PD-L1 antibody atezolizumab (1200 mg) and autologous Wilms' tumor 1 mRNA-electroporated dendritic cell (WT1/DC) vaccination (8-10 x 106 cells/vaccination). Additional atezolizumab (1680 mg) doses and/or WT1/DC vaccinations (8-10 x 106 cells/vaccination) can be administered optionally following completion of the chemo-immunotherapy scheme. Follow-up of patients will last for up to 90 days after final atezolizumab administration and/or WT1/DC vaccination or 24 months after diagnosis, whichever occurs later. The trial's primary endpoints are safety and feasibility, secondary endpoints are clinical efficacy and immunogenicity. This phase I/II trial will evaluate whether addition of atezolizumab and WT1/DC vaccination to frontline standard-of-care chemotherapy for the treatment of epithelioid MPM is feasible and safe. If so, this novel combination strategy should be further investigated as a promising advanced treatment option for this hard-to-treat cancer.