Up to 400 million individuals globally are estimated to experience persistent symptoms, including fatigue, muscle pain, and brain fog, following severe acute respiratory syndrome coronavirus type 2 infection. These persistent symptoms are referred to as Post-COVID-19 condition if they last for more than 12 weeks after infection and persist for at least 8 weeks and often causing significant distress and burden. The underlying pathological mechanisms have not yet been fully elucidated. Due to the heterogeneity of the disease a multifactorial origin is highly likely. Overall, evidence on optimal management is limited, and no medication has yet proven to be effective. Current symptom management and treatment guidelines suggest a biopsychosocial perspective and emphasize multidisciplinary approaches. Comprehensive interventions, adequate treatment access, and appropriate resources remain insufficiently available and implementing digital interventions might help mitigate these limitations. This protocol details a single-site feasibility and clinical evaluation study aiming to bridge this gap. By implementing an exploratory, open-label, digital interventional approach this study investigates the feasibility and efficacy of a 12-week program delivered by a cloud-based application. The program consists of 13 modules encompassing a wide range of topics (e.g., energy management, self-care, stress management) and includes informational (e.g., psychoeducational content) and interactive (e.g., exercises, self-reflection diaries) components. Customization options align the material with participant needs. A dedicated feedback section in each module captures feedback regarding usability and feasibility. Participants are monitored and checked for adherence throughout the study. The primary outcome is the post-intervention change in functional capacity measured by the World Health Organization Disability Assessment Schedule 2.0. All participants provide written informed consent. Key results from the study will be published in peer-reviewed journals.
INTRODUCTION:In the revised DSM-5, Somatic Symptom Disorder (SSD) no longer requires medically unexplained symptoms and instead focuses on psychobehavioral positive criteria, applicable regardless of the underlying cause. Evidence on the frequency and characteristics of SSD among medically hospitalized inpatients remains scarce. We therefore investigated SSD frequency and age- and gender-associated characteristics in this population. METHODS:This cross-sectional analysis used baseline data from SomPsyNet, an intervention targeting SOMatic hospital inpatients to prevent PSYchosocial distress through a care NETwork. SSD was assessed using the Somatic Symptom Scale-8 (SSS-8) and the Somatic Symptom Disorder-B Criteria Scale (SSD-12), applying DSM-5-aligned and established cut-offs. Criteria were operationalized as A) somatic symptom burden (SSS-8 sum score ≥ 9 or per item≥3), B) symptom-related distress (SSD-12 ≥ 23), and C) proxies for symptom persistence. Associations with age were examined using robust regression. RESULTS:Among 3109 inpatients enrolled between June 2020 and December 2022, 20.6 % (SSS-8 sum score ≥ 9) to 21.9 % (SSS-8 per item≥3) met all three SSD criteria. Among the 25.5 % of patients positive for Criterion B (SSD-12 ≥ 23), Criteria A and C were frequently also met. No female predominance in symptom-related distress was observed. Younger patients reported higher somatic symptom burden and symptom-related distress (SSS-8: B = -0.04, t = -7.51; SSD-12: B = -0.05, t = -5.11). CONCLUSION:Symptoms consistent with DSM-5 SSD criteria were common among medically hospitalized inpatients. These findings underscore the frequency of SSD-related distress in this setting, highlight age- and gender-related differences in symptom presentation, and emphasize the need for further research to clarify its clinical implications.
Background : Somatic symptom disorder (SSD), as defined in DSM-5, emphasizes psychobehavioral responses to somatic symptoms and specifies three severity levels (mild, moderate, severe). However, the clinical relevance of these levels remains insufficiently established, particularly in medical inpatients. We examined whether a DSM-5–aligned self-report-based operationalization of these severity levels corresponds to clinically meaningful differences in health status. Methods : Cross-sectional analysis of baseline observational data from SomPsyNet, an intervention addressing psychosocial distress at three somatic hospitals in Basel, Switzerland (06/2020–12/2022). SSD was evaluated with the Somatic Symptom Scale-8 (SSS-8), Somatic Symptom Disorder-B Criteria Scale (SSD-12), and persistence indicators. Severity levels were derived from the number of SSD-12 subdimensions scoring≥10. Health status was assessed through SF-36 Mental/Physical Component Summary scores (MCS, PCS). Group differences and receiver operating characteristics were analyzed. Results : The sample comprised 2,951 inpatients. Overall, 20.5% met criteria for any SSD severity level (95%CI: 19.1–22.0%): 9.0% mild (95%CI: 8.0–10.1%), 1.0% moderate (95%CI: 0.7–1.4%), 10.5% severe (95%CI: 9.5–11.7%). SSD-positive participants had lower MCS/PCS than SSD-negative participants (each p <.001). Severe cases had lower MCS than mild cases (9.8-point difference, p <.001), whereas PCS did not differ. The predefined SSD-12 subdimension cut-off≥10 showed better discrimination of impaired mental health than the stricter cut-off≥12 (AUC 0.70 vs. 0.65; p <.001). Conclusions : Our DSM-5–aligned SSD severity classification yielded few moderate cases and clearer differentiation between mild and severe groups. Severity differences were reflected in mental rather than physical health status. These findings support clinical relevance of symptom-related distress in medical inpatients. Registry: ClinicalTrials.gov, TRN: NCT04269005, Registration date: 13 February 2020.
BACKGROUND:Up to one-third of medical inpatients experience clinically relevant mental distress, yet many remain untreated. Stepped and collaborative care (SCC) models may improve access to mental health care, but predictors of service uptake are unclear. We examined patient- and ward-level predictors of psychosomatic-psychiatric consultation (PPC). METHODS:We analyzed data from SomPsyNet, a stepped-wedge cluster randomized trial targeting SOMatic inpatients across three Swiss tertiary hospitals, to prevent PSYchosocial distress by a care NETwork. Analyses focused on inpatients screening positive for mental distress. Multiple-imputed logistic regressions assessed predictors of four sequential service-use stages: PPC considered, offered, accepted, and received. RESULTS:Among 589 distressed patients, 93.9% were offered PPC, 63.1% accepted, and 83.9% of acceptors received PPC, yielding a 50% overall receipt rate. Patients without Swiss citizenship showed higher odds of acceptance (odds ratio [OR] = 1.82 [1.10, 3.00]) and eventual receipt (OR = 1.62 [1.01, 2.62]). Being in a geriatric ward facilitated PCC uptake, while patients from gynecology showed reduced progression through the care pathway. Age, gender, income, education, marital status, and living arrangement showed no statistically robust associations. CONCLUSIONS:Almost two-thirds of mentally distressed medical hospital inpatients accepted an offered PPC, indicating high acceptability. About half ultimately received a consultation, highlighting substantial attrition along the SCC pathway. Ward specialty and nationality were key determinants of PPC uptake. These findings suggest that proactive, ward-oriented consultation-liaison models embedded in routine inpatient care may improve timely and equitable access to mental healthcare, including for migrant and minority patients who are otherwise less likely to access such care.
BACKGROUND: Patients with serious, life-limiting diseases often experience substantial emotional and spiritual distress, death anxiety, depressive symptoms, and loss of dignity. Fostering dignity and meaning and relieving psychological distress have been identified as core objectives of palliative care. To address the individual needs of palliative patients, a personalized, modular intervention approach may be advantageous. AIM: Based on previous work, we aimed to develop a personalized, modular approach to improve dignity, meaning, and mindfulness in palliative care patients. METHODS: An expert panel of international specialists in palliative care, dignity therapy, psychotherapy, clinical psychology, psychiatry, and psychosomatic medicine was convened to develop the proposed modular approach. Intervention development is described following the “Template for Intervention Description and Replication” TIDieR guidance and is based on results from a literature search on previous work on dignity, meaning-centered therapy, and mindfulness-based interventions, as well as on in-depth needs assessments. RESULTS: Based on the expert consensus, a three-modular approach was formulated, with evidence-based modules providing Dignity Therapy, Managing Cancer and Living Meaningfully (CALM) therapy, and mindfulness-based interventions, each addressing complementary aspects. CONCLUSION: A personalized, modular intervention to promote dignity, meaning, and mindfulness in palliative care patients was developed by a panel of international experts using existing dignity-fostering end-of-life interventions. The resulting modular approach was designed with the aim to address patients’ individual needs.
BACKGROUND:Persistent physical symptoms (PPS) are distressing bodily complaints that persist irrespective of underlying etiology and represent a descriptive, transdiagnostic umbrella concept. Psychodynamic models highlight attachment-related affect-regulation difficulties and impaired mentalizing as potentially relevant mechanisms. With the introduction of DSM-5, somatic symptom disorder (SSD) was conceptualized as a subgroup within the PPS spectrum characterized by excessive symptom-related thoughts, feelings, and behaviors, requiring re-evaluation of previous psychodynamic findings. METHODS:This cross-sectional study (Germany, 02-12/2017) compared three matched groups (96 PPS patients with a positive SSD screen, 96 PPS patients without a positive SSD screen, and 96 healthy controls (HC)) using standardized self-report measures of psychological burden, adverse childhood experiences, attachment, mentalizing, and personality functioning. Symptom-related thoughts, feelings, and behaviors were additionally examined dimensionally across the PPS spectrum. RESULTS:Compared with patients with PPS without SSD, those screening positive for SSD showed higher attachment anxiety (η2 = 0.054; small-to-moderate effect), greater impairments in mentalizing (η2 = 0.047; small-to-moderate effect), and personality functioning (η2 = 0.069; moderate effect). Both PPS groups reported higher attachment avoidance than HC, whereas elevated attachment anxiety was specific to the SSD group. Across the PPS spectrum, psychodynamic impairments were most pronounced at high levels of symptom-related thoughts, feelings, and behaviors. CONCLUSIONS:Among patients with PPS, those screening positive for SSD showed higher attachment anxiety and impairments in mentalizing and personality functioning. These psychodynamic impairments appear to show a threshold pattern at high levels of symptom-related thoughts, feelings, and behaviors, suggesting that assessment of psychodynamic characteristics may help identify patients for more targeted interventions. TRIAL REGISTRY:[DRKS00011685].
Chronic pruritus (CP), attention-deficit/hyperactivity disorder (ADHD), and skin picking disorder (SPD) are medical conditions that involve both somatic and psychosocial dimensions, posing unique challenges in clinical management. While CP and SPD are often observed together, the link between ADHD and these conditions is less recognized. This conceptual work describes three women who suffered from a complex interplay of CP, ADHD, and SPD treated at our specialized bi-disciplinary psychodermatological pruritus clinic. Based on our clinical observation and a narrative review of the literature, we assume a bidirectional, triangular relationship between CP, ADHD, and SPD. To support this assumption, we propose two hypotheses: (1) a neurodevelopmental hypothesis, emphasizing that an underlying neurodevelopmental disorder, in this case, ADHD, might present with symptoms like dysfunction of sensory processing, impulsivity, and attention deficits as shared features that reinforce CP and SPD, and (2) a neuroinflammatory hypothesis, suggesting that similar neuroinflammatory signatures promote the co-occurrence of CP, ADHD, and SPD. In addition, we provide specific suggestions derived from our clinical experience on how to manage patients with this complex combination of conditions. Elucidating the interplay between CP, ADHD, and SPD might help develop personalized treatment strategies and improve outcomes.
Background:Large language models (LLMs) are increasingly used in mental health, showing promise in assessing disorders. However, concerns exist regarding their accuracy, reliability, and fairness. Societal biases and underrepresentation of certain populations may impact LLMs. Because LLMs are already used for clinical practice, including decision support, it is important to investigate potential biases to ensure a responsible use of LLMs. Anorexia nervosa (AN) and bulimia nervosa (BN) show a lifetime prevalence of 1%-2%, affecting more women than men. Among men, homosexual men face a higher risk of eating disorders (EDs) than heterosexual men. However, men are underrepresented in ED research, and studies on gender, sexual orientation, and their impact on AN and BN prevalence, symptoms, and treatment outcomes remain limited. objectives:We aimed to estimate the presence and size of bias related to gender and sexual orientation produced by a common LLM as well as a smaller LLM specifically trained for mental health analyses, exemplified in the context of ED symptomatology and health-related quality of life (HRQoL) of patients with AN or BN. Methods:We extracted 30 case vignettes (22 AN and 8 BN) from scientific papers. We adapted each vignette to create 4 versions, describing a female versus male patient living with their female versus male partner (2 × 2 design), yielding 120 vignettes. We then fed each vignette into ChatGPT-4 and to "MentaLLaMA" based on the Large Language Model Meta AI (LLaMA) architecture thrice with the instruction to evaluate them by providing responses to 2 psychometric instruments, the RAND-36 questionnaire assessing HRQoL and the eating disorder examination questionnaire. With the resulting LLM-generated scores, we calculated multilevel models with a random intercept for gender and sexual orientation (accounting for within-vignette variance), nested in vignettes (accounting for between-vignette variance). Results:In ChatGPT-4, the multilevel model with 360 observations indicated a significant association with gender for the RAND-36 mental composite summary (conditional means: 12.8 for male and 15.1 for female cases; 95% CI of the effect -6.15 to -0.35; P=.04) but neither with sexual orientation (P=.71) nor with an interaction effect (P=.37). We found no indications for main effects of gender (conditional means: 5.65 for male and 5.61 for female cases; 95% CI -0.10 to 0.14; P=.88), sexual orientation (conditional means: 5.63 for heterosexual and 5.62 for homosexual cases; 95% CI -0.14 to 0.09; P=.67), or for an interaction effect (P=.61, 95% CI -0.11 to 0.19) for the eating disorder examination questionnaire overall score (conditional means 5.59-5.65 95% CIs 5.45 to 5.7). MentaLLaMA did not yield reliable results. Conclusions:LLM-generated mental HRQoL estimates for AN and BN case vignettes may be biased by gender, with male cases scoring lower despite no real-world evidence supporting this pattern. This highlights the risk of bias in generative artificial intelligence in the field of mental health. Understanding and mitigating biases related to gender and other factors, such as ethnicity, and socioeconomic status are crucial for responsible use in diagnostics and treatment recommendations.
BACKGROUND:The effect of a shared decision-making approach on patients' code status decisions remains unknown. We compared an approach for shared decision-making with usual care to evaluate the effect on patients' code status preferences and quality of decision-making. METHODS:In a pragmatic cluster-randomized controlled trial conducted in six teaching hospitals in Switzerland, we randomly assigned residents to conduct code status discussions based on either an approach incorporating didactic teaching, observation, and feedback and a shared decision-making checklist with a decision aid, or usual care. The primary end point was patients choosing a do-not-resuscitate (DNR) code status in the event of a cardiac arrest. The key secondary end point was patients' decisional uncertainty, measured by the Decisional Conflict Scale (range 0 to 100, with lower scores indicating lower decisional uncertainty). RESULTS:A total of 206 residents caring for 2663 medical patients were included in the trial. Compared with patients in the usual care group, patients in the intervention group had a significantly higher frequency of choosing DNR as their code status (685/1370 (50.0%) vs. 481/1293 (37.2%); adjusted risk ratio, 1.37 (95% confidence interval, 1.25 to 1.50); P<0.001). The intervention was associated with lower decisional uncertainty (Decisional Conflict Scale score, 14.4±15.3 vs. 21.8±20.2 points; adjusted difference, -7.06 (95% confidence interval, -9.43 to -4.68). CONCLUSIONS:An approach for shared decision-making that included the discussion of expected outcomes had a significant influence on the code status of medical patients, with a higher preference for DNR code status, and was associated with less uncertainty around the decision. (Funded by the Swiss National Science Foundation and the Swiss Society of General Internal Medicine; ClinicalTrials.gov number, NCT03872154.).
Introduction The recent pandemic caused by SARS-CoV-2 had a profound global impact. While many individuals recovered from COVID-19, some developed long-lasting symptoms that significantly disrupted daily life. The WHO defines this condition as post-COVID-19 condition (PCC). Common symptoms include fatigue, dyspnoea, sleep disturbances and cognitive difficulties. Increasing evidence suggests that PCC is a multifactorial condition, shaped not only by biomedical but also psychological and social factors. This article presents the protocol of the Basel Long COVID Cohort Study (BALCoS), which aims to improve understanding of PCC by capturing clinical, functional and psychosocial aspects through repeated assessments over the course of 1 year.Methods and analysis BALCoS is a prospective, single-site cohort study. Inclusion criteria include either a probable or confirmed history of SARS-CoV-2 infection with persistent symptoms consistent with the WHO definition of PCC, sufficient German language skills and age ≥18 years. At baseline, we collected detailed information on previous SARS-CoV-2 infections, symptom history, reinfections, COVID-19 vaccination status and pre-existing medical conditions. The study includes standardised psychometric assessments, physical performance tests, ecological momentary assessments (EMAs), neurocognitive testing and blood sample collection. Assessments are scheduled at baseline and at 3-month, 6-month and 12-month follow-up. All participants complete psychometric assessments at each time point. Blood samples are only collected at baseline. Neurocognitive testing and physical performance measures are collected at baseline and 12-month follow-up for in-person participants only. Participants who are unable to attend in person complete a remote version of the study, excluding these in-clinic assessments. EMAs are initiated the day after each time point and consist of eight questions over 10 consecutive days. The study is exploratory in nature, with a target sample size of 120 participants. BALCoS is part of the Horizon Europe Long COVID project, a multinational interdisciplinary research consortium integrating mechanistic, clinical and interventional studies.Ethics and dissemination The study was approved by the Ethics Commission of Northwest and Central Switzerland (BASEC-ID: 2023–00359) and is registered at ClinicalTrials.gov (ID: NCT05781893). All participants provide written informed consent. Study findings will be disseminated through peer-reviewed publications.Trial registeration number NCT05781893.
Abstract Background Harmonizing core outcome domains allows for pooling data, comparing interventions, and streamlining research evaluation. At the same time clinicians require concise and feasible measures for routine practice. Considering the heterogeneity of post-COVID-19 condition, a biopsychosocial approach requires sufficient coverage of the psychosocial dimension with assessments. Previous recommendations for core outcome sets have serious limitations regarding the psychosocial aspects of post-COVID-19 condition. This paper specifically focuses on psychosocial outcomes for adults with post-COVID-19 condition, providing both a comprehensive set of outcome domains for research and a streamlined clinical core set tailored for routine clinical use. Methods In a structured Consensus Development Approach, the European Network to improve diagnostic, treatment, and healthcare for patients with persistent somatic symptoms (EURONET-SOMA) developed psychosocial core outcome domains and assessments regarding post-COVID-19 condition. The experts identified variables and instruments which should be considered in studies on adults suffering from post-COVID-19 condition, and which are feasible in the clinical setting and relevant for research. Results We identified three higher-order dimensions with each encompassing several domains: The first higher-order dimension, “outcomes”, encompasses (1) the classification/ diagnostics of post-COVID-19 condition, (2) somatic symptoms (including fatigue), (3) the psychopathological status and mental comorbidities, (4) the physical status and somatic comorbidities, (5) neurocognitive symptoms, and (6) illness consequences. The second higher-order domain “mechanisms” encompasses (7) cognitive components, (8) affective components, (9) behavioral components, (10) social components, and (11) psychobiological bridge markers (e.g., neuroimmunological and psychoneuroendocrinological variables). The third higher-order domain, “risk factors”, includes factors such as (12) socioeconomic status and sociocultural factors, (13) pre-existing mental and somatic health issues, (14) personality factors (e.g., neuroticism), (15) adverse childhood experiences, (16) ongoing disability or pension claim, and (17) social media use. For each domain, specific instruments are suggested for research purposes and clinical use. Conclusions The recommended core domains help to increase consistency in a biopsychosocial approach to post-COVID-19 condition across investigations, improve synergies, and facilitate decision-making when comparing different interventional approaches. It allows to better identify relevant subgroups in heterogeneous post-COVID-19 condition populations offering practical tools for routine clinical practice through the clinical core set.