Bernd Löwe

Background: Persistent physical symptoms are common in general practice and often occur as part of a somatic symptom disorder. Patients suffering from somatic symptom disorders and their general practitioners (GPs) often experience barriers to mutual trust and effective care. Frequently, studies using a one-sided perspective bear mutual accusation about shortcomings of the respective other side. This study examines corresponding perspectives of patients with somatic symptom disorders and their treating GPs to capture their views on individual patient histories and thereby identify barriers to and potentially helpful aspects of communication, detection, care for and live with somatic symptom disorders. Methods: Qualitative face-to-face interviews were conducted with dyads of patients with somatic symptom disorders and their treating GPs. The interviews focused on the patients’ medical history as well as barriers and facilitators of management and care in general practice. Patients and their respective GPs were interviewed separately using a semi-structured interview guide. Interviews were digitally recorded and transcribed verbatim. Transcripts were analyzed using the qualitative content analysis approach described by Mayring. Results: We interviewed 15 patient-GP dyads (i.e., 30 interviews). The interviews yielded three general aspects of living with and caring for somatic symptom disorders from the complementing perspectives of patients and their treating GPs: (1) The (undisclosed) patient side (partly invisible to the GP), (2) the shared part of the consultation in general practice, and (3) GPs’ management and care. Patients and GPs alike talked about consultations focusing mainly on communicational and relational aspects. Patients painted a picture of living with somatic symptom disorders, giving details about the relevance of personal situation, relationships, and their work situation for their symptoms and illness management. GPs’ focus lay on coordinating functions, and treatment and management strategies for patients with somatic symptom disorders. Conclusion: To establish a trusting relationship between patient and general practitioner, removal of time constraints for consultations and preoccupations for symptom management should allow for better insights of the general practitioners in patients’ lives. If we allow for time to let the patient-doctor relationship grow, mutual trust may ensue. German clinical trial register: ID: DRKS00011380, registration date: 1st December 2016.

Introduction: Chronic back pain is a leading cause of disability worldwide and is increasingly understood as a biopsychosocial condition involving not only nociceptive but also autonomic and cognitive-emotional mechanisms. Dysregulation of the autonomic nervous system, reflected in reduced heart rate variability (HRV), has been identified as a potential biomarker of chronic pain vulnerability. Simultaneously, maladaptive pain expectations can amplify perceived pain and contribute to symptom persistence. HRV-based biofeedback, which aims to restore autonomic balance through paced breathing, represents a promising but underexplored approach to modulating both physiological and psychological aspects of chronic pain. This study aims to examine the relationship between daily HRV patterns, pain expectation and pain experience in individuals with chronic back pain, evaluate the feasibility and effectiveness of HRV biofeedback training in improving HRV and reducing pain and explore potential changes in patients’ illness understanding following the intervention. Methods and analysis: The study employs a mixed-method randomised controlled design. Participants with chronic back pain will be randomly assigned to an HRV biofeedback intervention group or a control group. Daily HRV will be continuously monitored using the Garmin Vivosmart 5 smartwatch and correlated with daily pain expectations and experiences. HRV-biofeedback under laboratory conditions will be carried out with the NeXus-4 biofeedback system (MindMedia). Feasibility and acceptability of the study design will be analysed through rates of recruitment, retention, adherence and the suitability of study procedures and outcome measures. Secondary to this, HRV will be analysed using both time- (SDNN, RMSSD) and frequency-domain (lnLF, lnHF) parameters. Pain expectation and daily pain experience will be assessed through ecological momentary assessment. Quantitative analyses will include Pearson/Spearman correlations, repeated-measures analyses of variance (ANOVAs) (Group×Time) and exploratory regression models. Qualitative data on illness perception will be analysed thematically. Ethics and dissemination: The study was approved by the Local Psychological Ethics Committee of the Center for Psychosocial Medicine at the University Medical Center Hamburg-Eppendorf (LPEK-0866). All participants will provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and academic theses, and de-identified data and analysis code will be made available in accordance with Findable, Accessible, Interoperable, Reusable (FAIR) data principles where ethically and legally feasible. Trial registration details: The study was registered with the ISRCTN registry ( ISRCTN19147367 ).

Zusammenfassung: Ziel dieser qualitativen Studie ist es, die Sichtweise von dermatologisch stationär behandelten Patient:innen hinsichtlich einer psychosomatischen Früherkennungsmaßnahme zu untersuchen. Diese qualitative Studie umfasst ein von Krankenpflegenden geleitetes psychosomatisches Screening mit anschließender Konsultation auf dermatologischen Stationen am Universitätsklinikum Hamburg-Eppendorf, Deutschland. Für ein erstes Screening wurde der Patient-Health-Questionnaire-4 (PHQ-4) von Pflegenden bereits bei der Aufnahme verwendet. Mit allen Patient:innen wurden einmal während des stationären Aufenthalts und einmal mindestens vier Wochen nach Entlassung Interviews geführt. Die Interviews wurden mittels thematischer Analyse ausgewertet. Für die Studie konnten neun Patient:innen (M = 50,1 Jahre; 4 Frauen, 5 Männer; 18–84 Jahre) rekrutiert werden, die im Rahmen einer Früherkennung auf psychische Komorbidität mittels Patient Health Questionnaire-4 positiv auf depressive Symptome oder Ängstlichkeit gescreent wurden. Bei der qualitativen Analyse wurden sieben Themen ermittelt, darunter die Wertschätzung einer ganzheitlichen Betreuung, Stigmatisierung, Hindernisse für eine psychologische Behandlung und die Struktur des Screenings. Im Allgemeinen schätzten alle Patient:innen die zusätzliche psychosomatische Versorgung, wiesen allerdings auch auf einige Hindernisse hin, wie z.B. lange Wartezeiten für eine Therapie und Stigmatisierung psychosomatischer Erkrankungen. Die qualitativen Ergebnisse unterstreichen eine positive Sichtweise von stationär dermatologisch behandelten Patient:innen auf die Früherkennung psychischer Komorbidität in der somatischen Versorgung: Zum einen wurde der ganzheitliche Versorgungsansatz begrüßt, zum anderen wurde die Kombination aus Früherkennungsmaßnahme und anschließender psychosomatischer Konsultation geschätzt. Als Herausforderungen wurden Stigmatisierung gegenüber psychosomatischen Erkrankungen und systemische Barrieren gesehen. In künftigen Studien sollte die Stichprobe vergrößert und die Fragestellung auf andere Disziplinen ausgedehnt werden.

Purpose: Symptom expectations are considered contributing mechanisms for underlying persistent somatic symptoms in somatic symptom disorder. Expectation framing has been suggested as a promising technique to modify expectations. However, the short-term interplay between symptom expectations, expectation framing, and symptom severity in patients with somatic symptom disorder remains unexplored. Methods: In this study, 217 patients with somatic symptom disorder participated in a 10-day smartphone-based ecological momentary assessment. Participants were randomized to one of two expectation framing groups either receiving prompts for the expected impairment due to somatic symptoms or for expected freedom from impairment. Symptom expectations and symptom severity were assessed three times daily. Results: Latent growth curve model analyses showed slight decreases in symptom expectations (slope = −0.08, z = −2.24, p  < 0.050) and symptom severity (slope = −0.08, z = −2.20, p < 0.050) over time. Growth trajectories for symptom expectations and symptom severity were strongly associated. Symptom severity decreased more rapidly among participants with lower initial symptom expectations compared to those with higher expectations ( β = −0.13, z = −2.69, p < 0.010). No significant effects were found for expectation framing. Conclusions: These findings highlight the associations between symptom expectations and somatic symptoms. Modifying expectations may be a promising factor for somatic symptom persistence, warranting further investigation into longer timeframes, more efficient strategies for expectation modification, and clinical application.

Introduction: The Anorexia Nervosa Treatment of Outpatients (ANTOP) randomized controlled trial involved 242 adult patients with anorexia nervosa. Patients from 10 German university hospitals were randomly allocated to 10 months of treatment with focal psychodynamic therapy (FPT), enhanced cognitive behaviour therapy (CBT-E), or optimized treatment as usual (TAU-O). At the end of treatment and follow-up no significant body mass index (BMI) differences between groups were reported. The present study is an explorative, secondary analysis of moderators of weight gain for FPT and CBT-E. Methods: N = 160 patients – randomized to FPT and CBT-E – were included in the analysis. Moderator analysis was conducted by using a mixed model approach for repeated measures (MMRM). The outcome variable was BMI at the last follow-up T5 (mean time of 5.96 years after the beginning of the study). Results: Low depression severity and high mental quality of life (QoL) at baseline moderated the outcome in favour of CBT-E, whereas high depression severity and low mental QoL was associated with a better outcome in FPT. Sensitivity analyses to predict BMI at earlier time points T1-T4 produced the same results. The direction of the moderator effects was the same for CBT-E and FPT across all time points. Graphical visualization confirms that there is a wide range where both treatments perform similarly, while CBT or FPT perform differently in the extreme ranges of these two variables. Conclusion: These findings suggest that baseline psychological burden may inform the selection of psychotherapy modality in anorexia nervosa, supporting a move toward personalized, mechanism-informed treatment allocation.

Objective: Somatic symptom disorder (SSD) is characterized by persistent physical symptoms causing significant distress. Unlike earlier criteria, SSD does not require the absence of other medical conditions, resulting in a heterogeneous patient population. Few studies have systematically compared SSD patients with and without somatic comorbidities. This study examined the frequency of somatic comorbidities in SSD and their associations with psychosocial characteristics and disorder severity. Methods: Cross-sectional data from the SOMA.SSD study were analyzed. SSD was diagnosed through the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Somatic comorbidity was assessed with the physician-rated Cumulative Illness Rating Scale (CIRS). Patients with and without somatic comorbidity were compared on psychosocial and clinical variables. Ordinal logistic regression identified factors associated with SSD severity. Results: A total of 241 SSD patients were included from a psychosomatic outpatient clinic (mean age: 44.5 y, SD 13.7; 66.8% female). SSD severity was mild in 35.7%, moderate in 38.6%, and severe in 25.7%. Mean CIRS score was 4.4 (SD: 3.18; range: 0 to 52), with 61.0% of patients having at least one somatic comorbidity. Patients with somatic comorbidity were older and reported lower physical but higher mental health-related quality of life. Higher health anxiety was associated with greater SSD severity ( β =0.287, p <.001), whereas somatic comorbidity was not linked to severity or psychosocial measures. Conclusions: Somatic comorbidities were common in SSD but did not influence severity or psychosocial profile, supporting the validity of the diagnosis independent of physical disease. Health anxiety emerged as a key correlate of severity, highlighting its relevance as a treatment target.

Background: Depression screening in primary care has been widely discussed, but its economic implications have remained largely unexplored. The GET.FEEDBACK.GP randomised controlled trial evaluated feedback interventions after depression screening in primary care. The study arms were (a) feedback provided to the general practitioner; (b) feedback to both the patient and the treating general practitioner; and (c) a control group without feedback. Analysis of clinical effectiveness revealed that feedback interventions were not associated with decreased depression severity. Their economic implications were the subject of this study. Aims: To evaluate the economic impact of general-practitioner- and patient-targeted feedback following depression screening for adults in German primary care. Method: A cost-effectiveness analysis from a societal perspective of feedback interventions after depression screening with a time horizon of 12 months was conducted. Direct and indirect costs were estimated. Quality-adjusted life years were calculated on the basis of the EQ-5D-5L, and incremental cost-effectiveness ratios and cost-effectiveness acceptability curves based on the net monetary benefit were constructed. Sensitivity analyses and post hoc explorative subpopulation analyses were performed. Trial registration: ClinicalTrials.gov, NCT03988985. Results: In total, 987 participants who screened positive for at least moderate depression were included. Feedback provision was not significantly associated with changes in costs or quality-adjusted life years during follow-up. Cost-effectiveness probabilities of feedback interventions were lower than 50% compared with no feedback. Higher cost-effectiveness probabilities were observed in patients whose suspected depression was confirmed 1 month post-screening and in those with previous depression. Conclusions: The analysed feedback interventions cannot be considered to be cost-effective for the investigated population. Patient-targeted feedback was potentially cost-effective for subpopulations, particularly patients with a later confirmed depression diagnosis; this requires further research.

Objectives: Enhanced recovery after surgery (ERAS) protocols are patient-centred, interprofessional perioperative care models aimed at reducing hospital stays, complications, healthcare costs, and improving patient satisfaction. Evidence for ERAS in cardiac surgery is scarce; therefore, we aimed to assess its efficacy and safety in minimally invasive heart valve surgery (MIHS). Methods: Interdisciplinary Perioperative Care in Minimally Invasive Heart Valve Surgery (INCREASE) is a randomized-controlled trial that compares ERAS with standard care in MIHS. The intervention group (IG) received ERAS-based treatment; the control group (CG) standard care. Co-primary end-points were in-hospital stay for cardiovascular reasons within 1 year postoperatively (superiority hypothesis) and physical performance (6-minute walk test [6MWT]) at discharge (non-inferiority hypothesis). Superiority hypothesis was tested primarily in surgically treated patients (modified intention to treat population), while non-inferiority hypothesis was tested in per protocol population. Results: In total, 201 patients scheduled for MIHS were randomized (IG: 101; CG: 100). Total weighted in-hospital stay within 1 year was non-significantly shorter in the IG (adjusted mean difference −2.7 days, 95% confidence interval (CI) (−6.3, 0.9), 1-sided P = .07). Sensitivity analyses favoured the IG (adjusted ratio 0.71, 95% CI, 0.6, 0.85). For 6MWT, adjusted mean difference was −14%, 95% CI (−43%, 15%) exceeding the non-inferiority margin of −15% (1-sided P = .48). Without baseline adjustment, 6MWT values revealed a mean difference between groups of −1%, 95% CI (−10%, 8%), reaching non-inferiority of the IG. Safety outcomes were comparable with the exception of an unexpected higher rate of post-operative atrial fibrillation in patients randomized to ERAS. Conclusions: ERAS is feasible and safe in MIHS. The trial did not demonstrate a reduction in length of hospital stay during the first postoperative year in the population studied. Exploratory analyses suggest that further evaluation of ERAS concepts is justified.