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.

ObjectiveCurrent diagnostic concepts of somatic symptom disorder (SSD) in DSM-5 and bodily distress disorder (BDD) in ICD-11 require certain psychological criteria, but researchers have called for further specification. Therefore, in a first step, this systematic review and meta-analysis aimed to summarize the current evidence on psychological factors associated with SSD/BDD and/or disorder-relevant clinical outcomes such as symptom severity and impairment.MethodsPsychological factors were systematically searched using Pubmed, Cochrane Library and Psycinfo via EBSCO. Studies providing original data in English or German, after 2009 were included. Cross-sectional, cohort and case-control studies investigating at least one psychological factor in individuals with SSD/BDD in the context of disorder-relevant outcomes were included.ResultsForty-three eligible studies (n = 3760 patients) in SSD (none in BDD) provided data on at least one psychological factor, 37 in case-control format, 10 cross-sectional and 5 longitudinal. Meta-analyses of the case-control studies found patients with SSD to be more impaired by depression (SMD = 1.80), anxiety (SMD = 1.55), health anxiety (SMD = 1.31) and alexithymia (SMD = 1.39), compared to healthy controls. Longitudinal results are scarce, mixed, and require refining, individual studies suggest self-concept of bodily weakness, anxiety and depression to be predictive for persistent SSD and physical functioning.ConclusionThis review provides a detailed overview of the current evidence of psychological factors in relation to SSD/BDD. Future studies on SSD and BDD should include under-studied psychological factors, such as negative affect, fear avoidance, or emotion regulation. More longitudinal studies are needed to assess the predictive value of these factors.

Background Despite the immense impact of Long COVID on public health and those affected, its aetiology remains poorly understood. Findings suggest that psychological factors such as depression contribute to symptom persistence alongside pathophysiological mechanisms, but knowledge of their relative importance is limited. This study aimed to synthesise the current evidence on psychological factors potentially associated with Long COVID and condition- relevant outcomes like quality of life. Methods In this systematic review and meta-analysis, MEDLINE, PsycINFO, and the Cochrane Database of Systematic Reviews were searched for peer-reviewed studies published in English from 2019 to January 2, 2024. Studies providing cross-sectional or longitudinal data on the association between at least one psychological variable and the presence of Long COVID (primary outcome) or condition-relevant secondary outcomes (symptom severity, impairment, quality of life, and healthcare utilisation) were included. Psychological constructs with at least fi ve comparisons were pooled as odds ratio (OR) for categorical data and standardised mean difference (SMD) for continuous data in random-effects meta-analyses of cross-sectional studies with control groups. This review is registered with PROSPERO, CRD42023408320. Findings 113 studies (n = 312,831 patients with Long COVID) provided data on at least one psychological variable, 63 in cross-sectional group comparisons, 53 in cross-sectional associations, and 18 longitudinal. Most reported fi ndings related to depression and anxiety, and - less frequently - to physical activity, posttraumatic stress disorder, stress, and history of mental illness. Depression (OR 2.35; 95% CI, 1.49-3.70) - 3.70) and anxiety (OR 2.53; 95% CI, 1.76-3.61) - 3.61) were significantly fi cantly associated with Long COVID and higher in affected patients than controls (depression: SMD 0.88; 95% CI, 0.66-1.11; - 1.11; anxiety: SMD 0.74; 95% CI, 0.50-0.99), - 0.99), while results for physical activity and stress were nonsignificant. fi cant. In most prospective studies, the investigated psychological constructs significantly fi cantly predicted Long COVID. Interpretation Evidence suggests depression and anxiety to be co-occurring phenomena and predictive factors of Long COVID. Future studies should prospectively investigate psychological constructs such as emotion regulation or dysfunctional symptom expectations, which are well-known risk factors and therapeutic targets of persistent somatic symptoms in other medical conditions, but are so far understudied in Long COVID. Funding None.

Objective: Treatment expectations alter the probability of experiencing unpleasant side effects from an intervention, including vaccinations. To date, expectations have mostly been assessed explicitly bearing the risk of bias. This study aims to compare implicit expectations of side effects from COVID-19 and flu vaccinations and to examine their relationships with vaccine attitudes and intentions. Methods: N = 248 participants took part in a cross-sectional online survey assessing explicit and implicit expectations, as well as vaccine-related attitudes and personal characteristics. A Single Category Implicit Association Test (SC-IAT) was developed to assess implicit side effect expectations. Explicit side effect expectations were measured with the Treatment Expectation Questionnaire (TEX-Q). Results: Whereas explicit and implicit expectations regarding COVID-19 vaccine were significantly correlated (r = -0.325, p < .001), those correlations could not be found regarding flu vaccine (r = -0.072, p = .32). Explicit measures (COVID-19: beta = -0.576, p < .001; flu: beta = -0.301, p < .001) predicted the intention to receive further vaccinations more than implicit measures (COVID-19: beta = -0.005, p = .93; flu: beta = 0.004, p = .96). Explicit measures (COVID-19: OR = 0.360, p < .001; flu: OR = 0.819, p = .03) predicted vaccination status, while implicit measures did not (COVID- 19: OR = 2.643, p = .35; flu: OR = 0.829, p = .61). Conclusion: Expectations to experience side effects from vaccinations can be measured implicitly, in addition to explicit measures. Further investigation needs to determine the relative contribution and additive value of using implicit measures to assess treatment expectations.

COPYRIGHT © 2023 Berens, Ehrenthal and Tesarz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Commentary: The framework for systematic reviews on psychological risk factors for persistent somatic symptoms and related syndromes and disorders (PSY-PSS)

Background Patients’ expectations, as a central mechanism behind placebo and nocebo effects, are an important predictor of health outcomes. Yet, theoretically based generic assessment tools allowing for an integrated understanding of expectations across conditions and treatments are lacking. Based on the preliminary 35-item version, this study reports the development and validation of the Treatment Expectation Questionnaire (TEX-Q), a generic, multidimensional self-report scale measuring patients’ expectations of medical and psychological treatments. Methods The TEX-Q was developed in a validation sample of n = 251 patients undergoing different treatments using exploratory factor analyses and item analyses, as well as analysis of convergent and divergent validity. Confirmatory factor analysis was conducted in an independent sample of n = 303 patients undergoing cancer treatment. Two-weeks test-retest reliability was assessed in n = 28 psychosomatic outpatients. Results Factor analyses revealed six theoretically founded stable subscales. The TEX-Q assesses expectations of treatment benefit, positive impact, adverse events, negative impact, process and behavioural control with a total of 15 items. Results for the subscales and the sum score indicated good internal consistency (α = .71-.92), moderate to high test-retest reliability (r = .39-.76) as well as good convergent validity with regard to other expectation measures (r = .42-.58) and divergent validity with regard to measures of generalized expectations (r < .32) and psychopathology (r < .28). Conclusions While further validation is needed, the results suggest that the TEX-Q is a valid and reliable scale for the generic, multidimensional assessment of patients’ treatment expectations. The TEX-Q overcomes constraints of ad-hoc and disease-specific scales, while allowing to compare the impact of different expectation constructs across conditions and treatments.

Introduction Seven of 10 patients with non-dialysis chronic kidney disease (CKD) experience burdensome persistent somatic symptoms (PSS). Despite the high prevalence and relevance for quality of life, disease progression and mortality, the pathogenesis of PSS in CKD remains poorly understood. The SOMA.CK study aims to investigate biopsychosocial predictors and their interactions for PSS in non-dialysis CKD and to develop a multivariate prognostic prediction model for PSS in CKD.Methods and analysis The study is a mixed-methods cohort study with assessments at baseline, 6 and 12 months. It aims to include 330 patients with CKD stages G2–4 (eGFR=15–89 mL/min/1.73 m2). Primary outcome is the CKD-specific somatic symptom burden assessed with the CKD Symptom Burden Index. Secondary outcomes include quality of life, general somatic symptom burden and functioning. The interplay of biomedical (eg, biomarkers, epigenetics), treatment-related (eg, therapies and medication) and psychosocial variables (eg, negative affectivity, expectations) will be investigated to develop a prognostic prediction model for PSS. In an embedded mixed-methods approach, an experimental study in 100 patients using an affective picture paradigm will test the effect of negative affect induction on symptom perception. An embedded longitudinal qualitative study in 40–50 newly diagnosed patients will use thematic analysis to explore mechanisms of symptom development after receiving a CKD diagnosis. SOMA.CK is part of the interdisciplinary research unit ‘Persistent SOMAtic Symptoms ACROSS Diseases’.Ethics and dissemination The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10195-BO-ff). Findings will be disseminated through peer-reviewed publications, scientific conferences, the involvement of our patient advisory board and the lay public. Focusing on subjective symptom burden instead of objective disease markers will fundamentally broaden the understanding of PSS in CKD and pave the path for the development of mechanism-based tailored interventions.Trial registration number ISRCTN16137374.

This study examined whether baseline (3–14 days pre-surgery) levels of (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs moderate the effects of additional preoperative interventions before coronary artery bypass graft surgery on (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs 1 day before surgery, 1 week and 6 months after surgery. In the PSY-HEART trial, 115 patients were assessed. They were randomized into one of three groups: 1. receiving standard medical care only (SMC), additional psychological interventions: 2. aiming to optimize patients’ expectations (EXPECT), or 3. focusing on emotional support. Patients with a higher baseline level of depressive symptoms receiving a preoperative psychological intervention indicated lower depressive symptoms 6 months after surgery compared to SMC. EXPECT increased personal control and concern levels in patients with low baseline personal control/concern 1 day before surgery. Brief preoperative psychological interventions can improve psychological outcomes in heart surgery patients. Baseline status may moderate these effects. The study has been approved by the medical ethics committee of the Philipps University of Marburg and has been pre-registered at www.clinicaltrials.gov (NCT01407055) on August 1, 2011.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

Introduction Persistent somatic symptoms (PSS) are highly prevalent in all areas of medicine; they are disabling for patients and costly for society. The subjective symptom burden often correlates poorly with the underlying disease severity, and patients’ needs for effective treatment are far from being met. Initial evidence indicates that, in addition to disease-specific pathophysiological processes, psychological factors such as expectations, somatosensory amplification and prior illness experiences contribute to symptom persistence in functional as well as in somatic diseases. However, prospective studies investigating the transition from acute to chronic somatic symptoms, integrating pathophysiological, psychological and social factors, are scarce. A better understanding of the multifactorial mechanisms of symptom persistence is crucial for developing targeted mechanism-based interventions for effective prevention and treatment of PSS. Thus, the overall aim of the interdisciplinary SOMACROSS research unit is to identify generic and disease-specific risk factors and aetiological mechanisms of symptom persistence across a range of diseases. Methods and analysis Seven projects will investigate risk factors and mechanisms of symptom persistence in a total of 3916 patients across 10 medical conditions. All study designs are prospective and share common assessment points, core instruments and outcome variables to allow comparison and validation of results across projects and conditions. Research will focus on the identification of generic and disease-specific mechanisms associated with unfavourable symptom course. The development of a multivariate prediction model will facilitate the understanding of the course of PSS across diseases. Ethics and dissemination All individual SOMACROSS studies were approved by the ethics committees of the Medical Chambers Hamburg and Münster, Germany. Findings will be disseminated through peer-reviewed publications, scientific conferences and the involvement of relevant stakeholders, patients and the lay public. This interdisciplinary research unit will fundamentally contribute to earlier recognition of patients at risk, and to the development of prevention and tailored treatment concepts for PSS.

Zusammenfassung Hintergrund Das gestufte, koordinierte und interdisziplinare Gesundheitsnetzwerk fur somatoforme und funktionelle Storungen (Sofu-Net) wurde entwickelt, um Patienten mit somatoformen und funktionellen Storungen leitliniengerecht zu versorgen. Diese Studie evaluiert die klinische Symptomatik der Patienten, ihre psychotherapeutische und arztliche Inanspruchnahme sowie deren Pradiktoren zur 4-Jahres-Katamnese einer kontrollierten Wirksamkeitsstudie. Methodik 219 Patienten mit Risiko fur somatoforme Storungen aus den Sofu-Net Praxen (n=119) und den Kontrollpraxen (n=100) wurden nach 4 Jahren mittels strukturierter Interviews erneut befragt. Outcomes zur 4-Jahres-Katamnese waren die klinische Symptomatik, die psychotherapeutische und arztliche Inanspruchnahme. Ergebnisse 127 Patienten (n=74 Sofu-Net, n=53 Kontrollpraxen) wurden nachbefragt. Im Vergleich zur Kontrollgruppe wurden die Sofu-Net Patienten signifikant haufiger in Psychotherapie vermittelt (55,4 vs. 35,8%). Ein jungeres Alter und haufigere Hausarztgesprache anlasslich psychosozialer Probleme sagten die psychotherapeutische Inanspruchnahme vorher. In der Auspragung der klinischen Symptomatik und im Ausma ss der arztlichen Inanspruchnahme konnte kein Unterschied zwischen den beiden Gruppen festgestellt werden. Wichtige Pradiktoren waren die Anzahl somatischer Erkrankungen, erhohte Krankheitsangst, weibliches Geschlecht, erhohte depressive Symptomatik sowie eine niedrige korperliche und psychische Lebensqualitat. Diskussion Langfristig gelang durch die koordinierte und interdisziplinare Netzwerkstruktur eine erfolgreichere Vermittlung von Risikopatienten in die Psychotherapie. Die Rolle des Hausarztes erwies sich dabei als wichtig. Allerdings ging dies weder mit einer Verbesserung des klinischen Zustandes der Patienten noch mit einer Abnahme der ambulanten arztlichen Inanspruchnahme einher. Abstract Background The stepped, coordinated, interdisciplinary Health Network for Somatoform and Functional Disorders (Sofu-Net) was developed to provide guideline-based care for patients with somatoform and functional disorders. This controlled cluster cohort study evaluated patients' mental and somatic health care use, clinical outcomes, and their predictors at 4-years follow-up. Method 219 patients at risk for somatoform disorders from Sofu-Net practices (n=119) and control practices (n=100) were resurveyed after 4 years using structured interviews. Outcomes were mental and somatic health care use, somatic symptom burden and depressive symptoms. Results 127 patients (n=74 Sofu-Net, n=53 controls) were followed up. Compared with the control group, Sofu-Net patients were significantly more likely to be referred to psychotherapy (55.4 vs. 35.8%). Younger age and more frequent GP consultations on the occasion of psychosocial problems predicted mental health care use. No difference was found between the two groups in the severity of clinical symptoms or in the extent of somatic health care use. Significant predictors were the number of somatic diseases, increased fear of illness, female gender, increased depressive symptomatology, low physical and mental quality of life. Discussion In the long term, the coordinated and interdisciplinary network structure succeeded in more successfully referring high-risk patients to psychotherapy. The role of the primary care physician proved to be important. However, this was not accompanied by an improvement in the patients' clinical condition or a decrease in outpatient physician utilization.

BACKGROUND:In 2013, the diagnosis of somatic symptom disorder (SSD) was introduced into the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This review aims to comprehensively synthesize contemporary evidence related to SSD. METHODS:A scoping review was conducted using PubMed, PsycINFO, and Cochrane Library. The main inclusion criteria were SSD and publication in the English language between 01/2009 and 05/2020. Systematic search terms also included subheadings for the DSM-5 text sections; i.e., diagnostic features, prevalence, development and course, risk and prognostic factors, culture, gender, suicide risk, functional consequences, differential diagnosis, and comorbidity. RESULTS:Eight hundred and eighty-two articles were identified, of which 59 full texts were included for analysis. Empirical evidence supports the reliability, validity, and clinical utility of SSD diagnostic criteria, but the further specification of the psychological SSD B-criteria criteria seems necessary. General population studies using self-report questionnaires reported mean frequencies for SSD of 12.9% [95% confidence interval (CI) 12.5-13.3%], while prevalence studies based on criterion standard interviews are lacking. SSD was associated with increased functional impairment, decreased quality of life, and high comorbidity with anxiety and depressive disorders. Relevant research gaps remain regarding developmental aspects, risk and prognostic factors, suicide risk as well as culture- and gender-associated issues. CONCLUSIONS:Strengths of the SSD diagnosis are its good reliability, validity, and clinical utility, which substantially improved on its predecessors. SSD characterizes a specific patient population that is significantly impaired both physically and psychologically. However, substantial research gaps exist, e.g., regarding SSD prevalence assessed with criterion standard diagnostic interviews.

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects. Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants. Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs. Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [ X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [ X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants ( F = 6.373, p = 0.013, partial η 2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations ( F = 16.857, p < 0.001, partial η 2 = 0.151). Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

Zusammenfassung Hintergrund Das gestufte, koordinierte und interdisziplinäre Gesundheitsnetzwerk für somatoforme und funktionelle Störungen (Sofu-Net) wurde entwickelt, um Patienten mit somatoformen und funktionellen Störungen leitliniengerecht zu versorgen. Diese Studie evaluiert die klinische Symptomatik der Patienten, ihre psychotherapeutische und ärztliche Inanspruchnahme sowie deren Prädiktoren zur 4-Jahres-Katamnese einer kontrollierten Wirksamkeitsstudie. Methodik 219 Patienten mit Risiko für somatoforme Störungen aus den Sofu-Net Praxen (n=119) und den Kontrollpraxen (n=100) wurden nach 4 Jahren mittels strukturierter Interviews erneut befragt. Outcomes zur 4-Jahres-Katamnese waren die klinische Symptomatik, die psychotherapeutische und ärztliche Inanspruchnahme. Ergebnisse 127 Patienten (n=74 Sofu-Net, n=53 Kontrollpraxen) wurden nachbefragt. Im Vergleich zur Kontrollgruppe wurden die Sofu-Net Patienten signifikant häufiger in Psychotherapie vermittelt (55,4 vs. 35,8%). Ein jüngeres Alter und häufigere Hausarztgespräche anlässlich psychosozialer Probleme sagten die psychotherapeutische Inanspruchnahme vorher. In der Ausprägung der klinischen Symptomatik und im Ausmaß der ärztlichen Inanspruchnahme konnte kein Unterschied zwischen den beiden Gruppen festgestellt werden. Wichtige Prädiktoren waren die Anzahl somatischer Erkrankungen, erhöhte Krankheitsangst, weibliches Geschlecht, erhöhte depressive Symptomatik sowie eine niedrige körperliche und psychische Lebensqualität. Diskussion Langfristig gelang durch die koordinierte und interdisziplinäre Netzwerkstruktur eine erfolgreichere Vermittlung von Risikopatienten in die Psychotherapie. Die Rolle des Hausarztes erwies sich dabei als wichtig. Allerdings ging dies weder mit einer Verbesserung des klinischen Zustandes der Patienten noch mit einer Abnahme der ambulanten ärztlichen Inanspruchnahme einher.

OBJECTIVE:Patients' expectations-as a central mechanism of placebo and nocebo effects-are an important predictor of health outcomes. However, the lack of a way to assess expectations across different settings restricts progress in understanding the role of expectations and to quantify their importance in medical and psychological treatments. The aim of this study was to develop a theory-based, generic, multidimensional measure assessing patient expectations of medical and psychological treatments.DESIGN:The Treatment Expectation Questionnaire (TEX-Q) was developed based on the integrative model of expectations and a systematic literature review of treatment expectation scales. After creating a comprehensive item pool, the scale was further refined by use of expert ratings and patient interviews.SETTING:Patients were recruited in primary care at two hospitals in Hamburg, Germany.PARTICIPANTS:13 scientific experts participated in the expert survey. 11 patients waiting for psychological or surgical treatments participated in the qualitative interviews.RESULTS:The 2×2×2 multidimensional structure of the TEX-Q assesses two expectation constructs (probabilistic vs value-based) across two outcome domains with two valences (direct benefits and adverse events, broader positive and negative impact), plus process and behavioural control expectations. We examined 583 items from 38 scales identified in the systematic review and developed 78 initial items. Content validity was then rated by experts according to item fit and comprehensibility. The best 53 items were further evaluated for comprehensibility, acceptability, phrasing preference and understanding by interviewing patients prior to treatment using the 'think aloud' technique. This resulted in a first 35-item version of the TEX-Q.CONCLUSIONS:The TEX-Q is a generic, multidimensional measure to assess patient expectations of medical and psychological treatments and allows comparison of the impact of multidimensional expectations across different conditions. The final TEX-Q will be available after psychometric validation.

Abstract. To improve early detection and adequate treatment for patients with somatic symptom and related disorders (SSRD), we implemented Sofu-Net, a stepped, collaborative, and coordinated health care network. This mixed-methods study aimed to evaluate Sofu-Net from the health care professionals’ perspective. Network partners (primary care physicians (PCPs), psychotherapists, inpatient mental health clinics) completed an evaluation survey. Following, qualitative analysis of focus groups explored facilitating factors and barriers of Sofu-Net. Of 66 network partners who completed the survey (response 83.5%), the majority was satisfied with Sofu-Net, and perceived improvements regarding management, early detection, and referral to mental health care. Both survey and focus groups identified interdisciplinary collaboration and diagnostic screening as most relevant facilitating factors. Important barriers to implementation included challenges in patient referral and structural factors. Necessary prerequisites for future stepped collaborative care for SSRD include structures facilitating diagnosis, inter-professional collaboration and referral, availability of mental health care, inclusion of comorbidities, and adequate reimbursement.

Introduction: Inflammation has been related to several somatic and psychological disorders and may moderate effects of psychological interventions. In the PSY-HEART trial patients benefitted from preoperative psychological interventions before undergoing coronary artery bypass graft surgery (CABG) and, if necessary, concomitant valvular surgery, compared to standard medical care. In this study we examined whether patients' baseline inflammatory status moderated the intervention effects. Material and methods: In a prospective three-arm randomized clinical trial with 6-months follow-up, 124 patients scheduled for CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT). Available baseline CRP-(n = 79), IL-6- (n = 78), IL-8- (n = 78) and TNF-alpha-(n = 80) parameters were considered as potential moderators (CRP as a categorical and continuous moderator). Linear mixed model analyses were calculated to test whether baseline inflammatory levels moderated intervention effects on disability, mental and physical quality of life at 6 months after surgery. Results: IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life. Follow-up tests indicated that EXPECT (and in part SUPPORT) led to lower postoperative disability and higher mental quality of life compared to SMC in patients with low baseline inflammatory markers. EXPECT indicated higher mental quality of life compared to SUPPORT in the high CRP subgroup. Patients in the SMC group had higher mental quality of life in the high CRP subgroup compared to the low CRP subgroup. Conclusion: Especially for patients with a lower inflammatory baseline status preoperative psychological interventions might be helpful to optimize long-term CABG surgery outcomes.