Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

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.

Early Psychological Interventions for Somatic Symptom Disorder and Functional Somatic Syndromes: A Systematic Review and Meta-Analysis.

OBJECTIVE: Psychological treatments for somatic symptom disorder and functional somatic syndromes (SSD/FSS) achieve moderate effects only, potentially because of the high chronicity in these patients. Therefore, we aimed to evaluate whether early treatment, that is, treatment in populations at risk or with recent onset, improves outcome. METHODS: We conducted a systematic review and meta-analysis of (cluster-)randomized controlled trials evaluating early psychological interventions in the prevention and treatment of SSD/FSS in adults compared with inactive control conditions, standard care, or placebo. Individuals at risk for SSD/FSS, suffering from subthreshold symptoms or new onsets of SSD/FSS, or presenting with SSD/FSS for the first time were included. RESULTS: We identified 30 eligible studies, mostly examining pain-related conditions. Interventions were diverse, ranging from bibliotherapy to cognitive-behavioral therapy. We found positive effects on depression post-treatment (Hedges' g = 0.12 [95% confidence interval = 0.03-0.2], k = 5) as well as on somatic symptom severity (g = 0.25 [0.096-0.41], k = 17) and health care utilization (g = 0.31 [0.18-0.44], k = 3) at follow-up. However, because of a high risk of bias, sensitivity to corrections for meta-bias, and missing outcome data, findings should be interpreted cautiously. CONCLUSIONS: Our review shows that targeting SSD/FSS at an early stage represents a conceptual and practical challenge. Readily accessible interventions addressing transsymptomatic processes of SSD/FSS development and consolidation are highly needed. Future studies are needed to evaluate individuals with diverse symptoms, examine symptom history thoroughly, use placebo controls, and report outcomes completely to determine the efficacy of early psychological interventions for SSD/FSS.PROSPERO Registration:CRD42020140122.

Baseline depressive symptoms, personal control, and concern moderate the effects of preoperative psychological interventions: the randomized controlled PSY-HEART trial.

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.

IL-8 and CRP moderate the effects of preoperative psychological interventions on postoperative long-term outcomes 6 months after CABG surgery - The randomized controlled PSY-HEART trial.

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.

Predictors of Seeking Psychotherapy in Primary Care Patients with High Somatic Symptom Burden.

Many primary care patients with high somatic symptom burden do not initiate mental health treatment. Using a cross-sectional design, this study aimed to identify predictors of psychotherapy seeking behavior for patients with high somatic symptom burden within the last 12 months. Data from 20 primary care practices were analyzed. Patients with high somatic symptom burden were identified using the Patient Health Questionnaire, structured interviews, and information from primary care physicians (PCPs). Within the final sample of 142 patients, 54 (38.03%) had been seeking psychotherapy. More severe somatic symptoms, taking psychopharmacological medication and frequently discussing psychosocial distress with PCPs, were associated with psychotherapy seeking behavior. Depressive and anxiety symptoms, and whether PCPs had diagnosed a somatoform disorder or recommended psychotherapy, were not. The results underline the importance of patient-related factors in psychotherapy seeking behavior.

Diagnosis of somatoform disorders in primary care: diagnostic agreement, predictors, and comaprisons with depression and anxiety.

BACKGROUND: To investigate (a) the diagnostic agreement between diagnoses of somatoform disorders, depressive and anxiety disorders obtained from a structured clinical interview and diagnoses reported from primary care physicians (PCPs) and (b) to identify patient and PCP-related predictors for the diagnostic agreement regarding the presence of a somatoform disorder. METHODS: Data from a cross-sectional study comprising 112 primary care patients at high risk for somatoform disorders were analyzed. Diagnoses according to International Classification of Diseases, 10th revision (ICD-10) for somatoform, depressive and anxiety disorders were obtained from the Composite International Diagnostic Interview (CIDI) and compared with the diagnoses of the patients' PCPs documented in their medical records. Using multiple regression analyses, predictors for the PCPs' diagnosis of a somatoform disorder were analyzed. RESULTS: The agreement between PCP diagnoses and CIDI diagnoses was 32.3% for somatoform disorders, 48.0% for depressive disorders and 25.0% for anxiety disorders. Multiple regression analyses revealed the likelihood of being diagnosed with a somatoform disorder by PCP increased with somatic symptom severity (OR = 1.22, 95% CI 1.03-1.44). Regarding PCP-related characteristics, a specialization in internal medicine (OR = 5.95, 95% CI 1.70-20.80) and working in a solo practice (OR = 2.92, 95% CI 1.02-8.38) increased the likelihood that patients were diagnosed with a somatoform disorder. CONCLUSIONS: The present results indicate that the process of diagnosing somatoform disorders in primary care needs to be improved. Findings further underline the necessity to implement appropriate strategies to improve early detection of patients. TRIAL REGISTRATION: ISRCTN ISRCTN55870770 . Registered 22 October 2014. Retrospectively registered.

Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial.

BACKGROUND: Placebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery. METHODS: In a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; "dose" of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables. RESULTS: Patients in the EXPECT group showed significantly larger improvements in disability (-12.6; -17.6 to -7.5) than the SMC group (-1.9; -6.6 to +2.7); patients in the SUPPORT group (-6.7; -11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed. CONCLUSIONS: Optimizing patients' expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine. TRIAL REGISTRATION: Ethical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at ( NCT01407055 ) on July 25, 2011.

Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial.

OBJECTIVE: The aim of the study was to examine whether preoperative psychological interventions targeting patients' expectations are capable of influencing the biological stress response after coronary artery bypass graft (CABG) surgery and could thus improve recovery after heart surgery. METHODS: Randomized controlled trial with assessments 10 days before surgery, after psychological intervention (day of hospital admission, but before surgery), postoperative (6-8 days later), and at follow-up (6 months after surgery). Eligible patients (N = 124) scheduled for elective on-pump CABG or CABG with valve replacement surgery were approached before hospital admission. Standard medical care (SMC) was compared with two additional preoperative psychological interventions: (a) an expectation manipulation intervention to optimize patients' expectations about course and outcomes or (b) supportive therapy, containing the same amount of therapeutic attention, but without specifically focusing on expectations. Postoperative plasma adrenaline, noradrenaline, and cortisol levels were a secondary outcome of our study (primary outcome patients' disability 6 months after surgery and other secondary patient-reported or clinical outcomes were reported elsewhere). RESULTS: Expectation manipulation intervention (3.68 ln pg/mL, 95% confidence interval = 3.38-3.98, p = .015) and supportive therapy (3.70 ln pg/mL, 95% confidence interval = 3.38-4.01, p = .026) led to significantly lower postoperative adrenaline levels compared with SMC (4.26 ln pg/mL, 95% confidence interval = 3.99-4.53) only. There were no treatment effects of the preoperative intervention for noradrenaline (p = .90) or cortisol (p = .30). Higher postoperative adrenaline levels predicted disability 6 months after surgery (r = .258, p = .018). CONCLUSIONS: In addition to SMC, preoperative psychological interventions seem to buffer psychobiological stress responses and could thus facilitate recovery from CABG surgery. Patients' postoperative stress responses could be an important factor for explaining trajectories of long-term outcomes. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov(NCT01407055).

What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy.

OBJECTIVES: Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. METHODS: Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. RESULTS: About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. CONCLUSION: Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd.

Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention.

Patients' expectations have shown to be a major psychological predictor of health outcome in cardiac surgery patients. However, it is unclear whether patients' expectations can be optimized prior to surgery. This study evaluates the development of a brief psychological intervention focusing on the optimization of expectations and its effect on change in patients' expectations prior to cardiac surgery. Ninety patients scheduled for coronary artery bypass graft were randomly assigned to (1) standard medical care, (2) additional expectation manipulation intervention (EMI), and (3) additional attention control group. Therapists' fidelity to intervention manuals and patients satisfaction with the intervention were assessed for both active intervention conditions. Patients' expectations about post-surgical disability, treatment control, personal control, and disease duration were assessed before and after the psychological intervention. Demographical, medical, and psychosocial characteristics and disability were assessed at baseline. Treatment fidelity and patient satisfaction was very high in both intervention conditions. Only patients receiving EMI developed higher personal control expectations and longer (more realistic) expectations of disease duration. The effect of intervention group on patients' disability expectations and patients' personal control expectations was moderated by patient's level of disability. EMI patients with low to moderate disability developed positive expectations whereas patients with high disability did not. This study shows the successful development of a short psychological intervention that was able to modify patients' expectations, especially in those with low to moderate disability. Given the robust association of expectations and surgery outcome, such an intervention might offer the opportunity to enhance patients' health following cardiac surgery.

Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence.

OBJECTIVE: Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. METHODS: An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1-3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. RESULTS: A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. CONCLUSION: Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.

Factors associated with disability expectations in patients undergoing heart surgery.

BACKGROUND: Heart surgery patients' expectations have been shown to be related to surgery outcome, independent of medical status. However, it is unclear which factors determine patients' expectations about disability following heart surgery. PURPOSE: Investigating the associations of patients' disability expectations with demographic, medical, and psychosocial factors as well as other aspects of patients' expectations might help to tailor psychological interventions more specifically to optimize patient's expectations. METHODS: Eighty-three patients were invited to a psycho-educational intervention to optimize expectations prior to elective coronary artery bypass graft (CABG). Before the psychological intervention and before surgery, disability expectations, demographical, medical, psychosocial variables as well as patient and treatment related expectations were collected via questionnaires and patients' files. Associations with disability expectations were assessed using hierarchical linear multiple regression analysis. RESULTS: Patients self-rated disability (ß = 0.50; p < 0.001) and beliefs about treatment efficacy (ß = -0.42; p < 0.001) was independently associated with disability expectations. Expectations about the efficacy of patients' own health behavior as well as demographical variables, psychological distress, perceived social support, and measures of medical morbidity did not explain any additional variance in patients' disability expectations. CONCLUSION: CABG patients seem to form their disability expectations upon their perceptions about their current disability and their expectations about the efficacy of treatment. Patients' disability expectations appear to be independent from scientifically established risk factors and other psychosocial patient characteristics in heart surgery. Future research is necessary to further determine what factors psychological interventions should focus on to modify patients' disability expectations.

The framework for systematic reviews on psychological risk factors for persistent somatic symptoms and related syndromes and disorders (PSY-PSS).

Introduction: Numerous psychological factors are believed to play a pivotal role in the development and maintenance of persistent somatic symptoms (PSS) in all fields of medicine. However, very few of these factors have been empirically investigated in relation to PSS. The aim of this study is firstly to propose a framework and define search terms for systematic reviews on the empirical evidence and diagnostic value of psychological risk factors for PSS and PSS-related outcomes (PSY-PSS). Secondly, the application of the framework is illustrated using the example of a systematic review on the relevance of psychological factors in somatic symptom disorders (SSD; DSM-5) and bodily distress disorders (BDD; ICD-11). Methods: Following a narrative review approach, two comprehensive lists of search terms to identify studies in (1) relevant patient groups with PSS and (2) relevant psychological factors were generated by reviewing the current literature and employing an iterative process of internal revision and external expert feedback. Results: We identified 83 relevant symptoms, syndromes and disorders for which we defined a total of 322 search terms (list 1). We further comprised 120 psychological factors into 42 subcategories and 7 main categories (list 2). The introduced lists can be combined to conduct systematic reviews on one or more specific psychological factors in combination with any symptom, syndrome or disorder of interest. A protocol of the application of this framework in a systematic review and meta-analysis on psychological etiological factors of SSD and BDD is presented following the PRISMA guidelines. Discussion: This framework will help to gather systematic evidence on psychological factors in order to improve the understanding of the etiology of PSS, to refine future diagnostic conceptualizations of PPS, and to develop optimized mechanism-based interventions for individuals with PPS and related syndromes and disorders.

The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations.

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.

Predictors of somatic symptom persistence in patients with chronic kidney disease (SOMA.CK): study protocol for a mixed-methods cohort study.

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.

Informing About the Nocebo Effect Affects Patients' Need for Information About Antidepressants-An Experimental Online Study.

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 η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 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.

Optimizing Expectations About Endocrine Treatment for Breast Cancer: Results of the Randomized Controlled PSY-BREAST Trial.

Background: Medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients' expectations. Optimizing expectations could minimize side effect burden. This study evaluated whether brief psychological expectation management training (EXPECT) optimizes medication-related expectations in women starting adjuvant endocrine therapy (AET) for breast cancer. Method: In a multisite randomized controlled design, 197 women were randomized to EXPECT, supportive therapy (SUPPORT), or treatment as usual (TAU). The three-session cognitive-behavioral EXPECT employs psychoeducation, guided imagery, and side effect management training. Outcomes were necessity-concern beliefs about AET, expected side effects, expected coping ability, treatment control expectations, and adherence intention. Results: Both interventions were well accepted and feasible. Patients' necessity-concern beliefs were optimized in EXPECT compared to both TAU and SUPPORT, d = .41, p < .001; d = .40, p < .001. Expected coping ability and treatment control expectations were optimized compared to TAU, d = .35, p = .02; d = .42, p < 001, but not to SUPPORT. Adherence intention was optimized compared to SUPPORT, d = .29, p = .02, but not to TAU. Expected side effects did not change significantly. Conclusion: Expectation management effectively and partly specifically (compared to SUPPORT) modified medication-related expectations in women starting AET. Given the influence of expectations on long-term treatment outcome, psychological interventions like EXPECT might provide potential pathways to reduce side effect burden and improve quality of life during medication intake.

Predicting suicidal ideation in primary care: An approach to identify easily assessable key variables.

OBJECTIVE: To obtain predictors of suicidal ideation, which can also be used for an indirect assessment of suicidal ideation (SI). To create a classifier for SI based on variables of the Patient Health Questionnaire (PHQ) and sociodemographic variables, and to obtain an upper bound on the best possible performance of a predictor based on those variables. METHODS: From a consecutive sample of 9025 primary care patients, 6805 eligible patients (60% female; mean age = 51.5 years) participated. Advanced methods of machine learning were used to derive the prediction equation. Various classifiers were applied and the area under the curve (AUC) was computed as a performance measure. RESULTS: Classifiers based on methods of machine learning outperformed ordinary regression methods and achieved AUCs around 0.87. The key variables in the prediction equation comprised four items - namely feelings of depression/hopelessness, low self-esteem, worrying, and severe sleep disturbances. The generalized anxiety disorder scale (GAD-7) and the somatic symptom subscale (PHQ-15) did not enhance prediction substantially. CONCLUSIONS: In predicting suicidal ideation researchers should refrain from using ordinary regression tools. The relevant information is primarily captured by the depression subscale and should be incorporated in a nonlinear model. For clinical practice, a classification tree using only four items of the whole PHQ may be advocated.

Health Care for Persistent Somatic Symptoms Across Europe: A Qualitative Evaluation of the EURONET-SOMA Expert Discussion.

Background: Persistent somatic symptoms (PSS), referred to as somatoform disorders and lately somatic symptom disorders, are frequent but often remain under-recognized and under-treated. Although European guidelines overlap, presumably, there is large diversity in their practical use and in the actual health care situation. The aim of this qualitative evaluation was to compare health care for PSS across 9 European countries, to illustrate commonalities and differences, and to discuss challenges for a pan-European research agenda. Methods: A case vignette fulfilling ICD-10 criteria of undifferentiated somatization disorder was presented to 24 experts from 9 European countries, who completed a semi-structured assessment regarding the routine management including diagnostic procedures, treatment recommendations, and country-specific health care aspects. A qualitative evaluation was conducted using the video-transcripts of the presentations. Results were validated by additional expert interviews. Results: Across all countries, primary care physicians serve as the gate keeper for further diagnostic and treatment procedures. Apart from this commonality, there is a large variability in health care routines. Experts concluded that individuals with PSS appear to be a non-identified patient group within many European health care systems. To overcome the gap between evidence-based guidelines and clinical reality needs, three key challenges were identified: (1) Defining a clinically useful, acceptable, and non-stigmatizing diagnostic term, (2) implementing guideline recommendations into routine care, (3) developing effective dissemination strategies. Conclusions: The results advocate for more research on the actual European health care situation. A systematic European research agenda with unified goals and interdisciplinary collaboration that integrates all stakeholders could answer this challenge.