The efficacy of automated feedback after internet-based depression screening (DISCOVER): an observer-masked, three-armed, randomised controlled trial in Germany.

BACKGROUND: Despite the availability of effective treatments, most depressive disorders remain undetected and untreated. Internet-based depression screening combined with automated feedback of screening results could reach people with depression and lead to evidence-based care. We aimed to test the efficacy of two versions of automated feedback after internet-based screening on depression severity compared with no feedback. METHODS: DISCOVER was an observer-masked, three-armed, randomised controlled trial in Germany. We recruited individuals (aged ≥18 years) who were undiagnosed with depression and screened positive for depression on an internet-based self-report depression rating scale (Patient Health Questionnaire-9 [PHQ-9] ≥10 points). Participants were randomly assigned 1:1:1 to automatically receive no feedback, non-tailored feedback, or tailored feedback on the depression screening result. Randomisation was stratified by depression severity (moderate: PHQ-9 score 10-14 points; severe: PHQ-9 score ≥15 points). Participants could not be masked but were kept unaware of trial hypotheses to minimise expectancy bias. The non-tailored feedback included the depression screening result, a recommendation to seek professional diagnostic advice, and brief general information about depression and its treatment. The tailored feedback included the same basic information but individually framed according to the participants' symptom profiles, treatment preferences, causal symptom attributions, health insurance, and local residence. Research staff were masked to group allocation and outcome assessment as these were done using online questionnaires. The primary outcome was change in depression severity, defined as change in PHQ-9 score 6 months after random assignment. Analyses were conducted following the intention-to-treat principle for participants with at least one follow-up visit. This trial was registered at ClinicalTrials.gov, NCT04633096. FINDINGS: Between Jan 12, 2021, and Jan 31, 2022, 4878 individuals completed the internet-based screening. Of these, 1178 (24%) screened positive for depression (mean age 37·1 [SD 14·2] years; 824 [70%] woman, 344 [29%] men, and 10 [1%] other gender identity). 6 months after random assignment, depression severity decreased by 3·4 PHQ-9 points in the no feedback group (95% CI 2·9-4·0; within-group d 0·67; 325 participants), by 3·5 points in the non-tailored feedback group (3·0-4·0; within-group d 0·74; 319 participants), and by 3·7 points in the tailored feedback group (3·2-4·3; within-group d 0·71; 321 participants), with no significant differences among the three groups (p=0·72). The number of participants seeking help for depression or initiating psychotherapy or antidepressant treatment did not differ among study groups. The results remained consistent when adjusted for fulfilling the DSM-5-based criteria for major depressive disorder or subjective belief of having a depressive disorder. Negative effects were reported by less than 1% of the total sample 6 months after random assignment. INTERPRETATION: Automated feedback following internet-based depression screening did not reduce depression severity or prompt sufficient depression care in individuals previously undiagnosed with but affected by depression. FUNDING: German Research Foundation.

Persistent physical symptoms: definition, genesis, and management.

Persistent physical symptoms (synonymous with persistent somatic symptoms) is an umbrella term for distressing somatic complaints that last several months or more, regardless of their cause. These symptoms are associated with substantial disability and represent a major burden for patients, health-care professionals, and society. Persistent physical symptoms can follow infections, injuries, medical diseases, stressful life events, or arise de novo. As symptoms persist, their link to clearly identifiable pathophysiology often weakens, making diagnosis and treatment challenging. Multiple biological and psychosocial risk factors and mechanisms contribute to the persistence of somatic symptoms, including persistent inflammation; epigenetic profiles; immune, metabolic and microbiome dysregulation; early adverse life experiences; depression; illness-related anxiety; dysfunctional symptom expectations; symptom focusing; symptom learning; and avoidance behaviours, with many factors being common across symptoms and diagnoses. Basic care consists of addressing underlying pathophysiology and using person-centred communication techniques with validation, appropriate reassurance, and biopsychosocial explanation. If basic care is insufficient, targeted psychological and pharmacological interventions can be beneficial. A better understanding of the multifactorial persistence of somatic symptoms should lead to more specific, personalised, and mechanism-based treatment, and a reduction in the stigma patients commonly face.

Stepped, evidence-based and integrated care service model vs. usual care for mental disorders: A randomized controlled trial (RECOVER).

Stepped, evidence-based and integrated care service models have the potential to be used as a reference for mental health services. RECOVER aimed to evaluate cost savings, effectiveness, and cost-effectiveness of such a model within a two arm, assessor- and data analysist-blinded RCT in Hamburg, Germany. Participants aged 16-79 years with mental disorders were randomly assigned either to RECOVER or treatment as usual (TAU). Primary outcomes comprised costs, effectiveness (combined symptoms, functioning, quality of life), and cost-effectiveness, hierarchically ordered. Outcomes were evaluated according to the ITT principle, group differences regarding costs with adjusted generalized linear models, effectiveness with ANCOVA models, and cost-effectiveness with the incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curves (CEACs). Between 1/1/2018 and 12/31/2020, n = 891 were finally included (n = 477 in RECOVER, n = 444 in TAU). RECOVER was associated with significantly lower annual total costs (-22 %), health and social care costs (-25 %) and hospital costs (-50 %). Effectiveness analyses showed a significantly better outcome for RECOVER with the fully imputed data . The CEACs descriptively demonstrated that RECOVER was cost-effective with a probability of >95 %. Treatment in RECOVER resulted in substantial cost reductions with better cost-effectiveness. RECOVER can be recommended as a reference model for comprehensive and integrated mental health services.

Somatic symptom disorder symptoms in individuals at risk for heart failure: A cluster analysis with cross-sectional data from a population-based cohort study.

OBJECTIVE: Identifying whether experienced symptom burden in individuals with medical predisposition indicates somatic symptom disorder (SSD) is challenging, given the high overlap in the phenomenology of symptoms within this group. This study aimed to enhance understanding SSD in individuals at risk for heart failure. SUBJECTS AND METHODS: Cross-sectional data from the Hamburg City Health Study was analyzed including randomly selected individuals from the general population of Hamburg, Germany recruited from February 2016 to November 2018. SSD symptoms assessed with the Somatic Symptom Scale-8 and the Somatic Symptom Disorder-12 scale were categorized by applying cluster analysis including 412 individuals having at least 5% risk for heart failure-related hospitalization within the next ten years. Clusters were compared for biomedical and psychological factors using ANOVA and chi-square tests. Linear regressions, adjusting for sociodemographic, biomedical, and psychological factors, explored associations between clusters with general practitioner visits and quality of life. RESULTS: Three clusters emerged: none (n = 215; 43% female), moderate (n = 151; 48% female), and severe (n = 46; 54% female) SSD symptom burden. The SSS-8 mean sum scores were 3.4 (SD = 2.7) for no, 6.4 (SD = 3.4) for moderate, and 12.4 (SD = 3.7) for severe SSD symptom burden. The SSD-12 mean sum scores were 3.1 (SD = 2.6) for no, 12.2 (SD = 4.2) for moderate, and 23.5 (SD = 6.7) for severe SSD symptom burden. Higher SSD symptom burden correlated with biomedical factors (having diabetes: p = .005 and dyspnea: p ≤ .001) and increased psychological burden (depression severity: p ≤ .001; anxiety severity: p ≤ .001), irrespective of heart failure risk (p = .202). Increased SSD symptoms were associated with more general practitioner visits (ß = 0.172; p = .002) and decreased physical quality of life (ß = -0.417; p ≤ .001). CONCLUSION: Biomedical factors appear relevant in characterizing individuals at risk for heart failure, while psychological factors affect SSD symptom experience. Understanding SSD symptom diversity and addressing subgroup needs could prove beneficial.

Healthcare professionals' views on factors influencing persistent somatic symptoms - ARISE-HCP online survey across countries.

OBJECTIVE: The Health Care Online Survey Europe-Healthcare Professionals (ARISE-HCP) cross-sectionally investigated healthcare professionals' (HCPs) views on healthcare factors influencing the symptom course of persistent somatic symptoms (PSS) across four European countries. METHODS: An online survey was developed for HCPs experienced in PSS care in Germany, Italy, Poland, and the Netherlands. The study employed a mixed-methods approach. Quantitatively, it assessed HCPs' perspectives on training, tools, and consultation times. Qualitatively, it explored their perceptions of healthcare-related factors influencing the PSS symptom course and systemic barriers encountered in treatment and diagnosis. RESULTS: Overall, 258 HCPs participated: 152 from the Netherlands, 46 from Germany, 30 from Italy, and 30 from Poland (67% female, mean age = 47.68 ± 11.64 years). HCPs' views on PSS training, tool adequacy, and consultation time sufficiency differed significantly. Regarding symptom persistence and deterioration, HCPs from Italy and Poland highlighted access-related issues, whereas German and Dutch HCPs focused on care implementation. Across all countries, interdisciplinary collaboration was mentioned as important for symptom improvement. A more holistic approach was advocated, emphasizing the need for comprehensive PSS-focused training and the integration of these practices in care delivery, service coordination, and patient engagement. CONCLUSION: Healthcare factors associated with the course of PSS and systemic treatment and diagnosis barriers varied across different countries, highlighting the importance of considering country-specific factors in managing PSS. Taking tailored measures to enhance multidisciplinary collaboration and HCP education is essential for improving patient outcomes, and sharing knowledge about effective healthcare practices across countries can improve patient care. Future research should focus on identifying systemic barriers to optimal care and developing country-specific interventions.

Somatic symptom profile in patients with chronic heart failure with and without depressive comorbidity.

Background: Patients with chronic heart failure (CHF) frequently suffer from depressive comorbidity. CHF and depressive comorbidity can cause somatic symptoms. The correct attribution of somatic symptoms is important. Thus, we aimed to assess potential differences in somatic symptom severity between CHF patients with and without depressive comorbidity. Methods: We evaluated depressive comorbidity using the Patient Health Questionnaire-9 (PHQ-9), somatic symptom severity with the Patient Health Questionnaire-15 (PHQ-15), and sociodemographic and medical variables in 308 CHF outpatients. To compare somatic symptom severity between CHF patients with and without depressive comorbidity, we conducted item-level analyses of covariance. Results: Of the 308 participating patients, 93 (30.3%) met the PHQ-9 criteria for depressive comorbidity. These patients did not differ from those without depressive comorbidity with regard to age, sex, left ventricular function, and multimorbidity. Patients with depressive comorbidity scored significantly higher on ten out of thirteen PHQ-15 items than patients without depressive comorbidity. The largest effect sizes (0.71-0.80) were shown for symptoms of headache, chest pain, shortness of breath, and palpitations, and the latter three were potentially attributable to heart failure. Conclusions: Among patients with CHF, somatic symptoms are more pronounced in those with depressive comorbidity than those without depressive comorbidity. This finding is especially true for cardiac symptoms independent of CHF severity. The potential interpretation of somatic symptoms as correlates of depressive comorbidity must be recognized in clinical practice.

A Pilot Study of Metacognitive Training in U.S. Republican Leaners: Reducing Polarization Toward LGBTIQ+ Persons.

Negative attitudes and stigmatization toward sexual minorities is a cause of minority stress of non-heterosexual persons on an individual level and has a negative impact on democratic coexistence in postmodern, plural society on a societal level. Derived from clinical research, we developed a short metacognitive training (MCT) intended to induce doubt toward inaccurate beliefs about LGBTIQ+ persons. We expected this MCT to reduce homonegativity, threat perceptions of LGBTIQ+ persons, and to foster extended outgroup tolerance compared to an education and a no-treatment control condition. We tested this hypothesis in U.S. Republican leaners who represent a social group that is likely to hold homonegative attitudes. We randomly assigned 490 U.S. Republican leaners to an MCT condition comprising 16 questions and respective answers (n = 166) vs. an education control condition (n = 164) vs. a no-treatment control condition (n = 160). We found that Republican leaners after receiving MCT (1) had a significant reduction of homonegativity (ds ≥ 0.28), (2) significantly perceived LGBTIQ+ persons as less threatening (ds ≥ 0.30), and (3) were significantly more tolerant of various outgroups such as LGBTIQ+ persons, feminists, liberals, and climate activists (ds ≥ 0.23) relative to both control conditions. The small effects of this short intervention and the possibility of systematically applying MCT in social discourse to reduce homonegativity with its potential significance for LGBTIQ+ individuals' mental health are discussed. Furthermore, we highlight this pilot study's significance toward intervention possibilities regarding political division and polarization in postmodern, democratic societies.

Psychometric evaluation of the patient health questionnaire stress scale.

The "Patient Health Questionnaire (PHQ)" is a screening instrument, designed for time-efficient detection and severity assessment of depression, anxiety, and other syndromes in medical settings. Besides the questions on psychological symptoms, there are items on psychosocial functioning, on stressors and critical life events. However, for the stress items there are no psychometric properties available until now. The present study is thought to investigate item characteristics, internal consistency as well as factorial and construct validity of the stress scale of the PHQ. A representative sample of the general population of Germany was collected by a demography consulting company (USUMA, Berlin). Per random-route procedure, households and members of the households were selected. The sample was representative for the German community regarding age, gender, and education. In this investigation the following questionnaires were administered: PHQ-Stress, Questions on Life Satisfaction Modules (FLZ-M), Type-D Scale-14 (DS14). The sample included N = 2396 participants with mean age of 48.50 (SD = 17.75; range = 14 to 92) and 55.2 % being female. Reliability of the PHQ stress scale was acceptable (ω = 0.776), but some factor loadings were comparatively low. Model fit indices showed mixed results, some indicating unacceptable and some indicating acceptable fit of the 10-item stress scale of the PHQ. Correlations with related constructs demonstrated the scale's convergent validity. The results of this validation study indicate that the PHQ stress scale, which provides a one-dimensional total stress score, is a valid, good practical and reliable self-report instrument for assessing the severity of psychosocial stress.

Patient-centered evaluation of an expectation-focused intervention for patients undergoing heart valve surgery: a qualitative study.

Objective: Randomized controlled trials demonstrate the effectiveness of expectation-focused interventions in improving recovery outcomes following cardiac surgery. For dissemination in routine health care, it is important to capture the perspective of affected individuals. This qualitative study explores the perceived benefits and intervention-specific needs of patients who received expectation-focused intervention in the context of heart valve surgery. In addition, it explores potential barriers and adverse effects. Methods: As part of an Enhanced Recovery After Surgery (ERAS) program within a multicentered randomized controlled trial, patients undergoing minimally invasive heart valve surgery received an intervention focused on their expectations. Six weeks after the intervention, semi-structured interviews were conducted with 18 patients to assess its feasibility, acceptance, barriers, benefits, and side effects. The transcribed interviews were analyzed using qualitative content analysis. Results: The results indicate that both the intervention and the role of the patient and psychologist are key aspects in evaluating the expectation-focused intervention. Five key themes emerged from the patients' perspective: personal needs, expectations and emotions, relationship, communication, and individuality. Patients valued the preparation for surgery and recovery and the space for emotions. Establishing a trustful relationship and addressing stigmatization were identified as primary challenges within the intervention. Conclusion: Overall, patients experienced the expectation-focused intervention as helpful and no adverse effects were reported. Perceived benefits included enhanced personal control throughout the surgery and recovery, while the potential barrier of stigmatization towards a psychologist may complicate establishing a trustful relationship. Addressing personal needs, as a relevant topic to the patients, could be achieved through additional research to identify the specific needs of different patient subgroups. Enhancing the expectation-focused intervention could involve the implementation of a modular concept to address individual needs better.

Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Intersectional inequalities in somatic symptom severity in the adult population in Germany found within the SOMA.SOC study.

Somatic symptoms are common in a wide range of medical conditions. In severe cases, they are associated with high individual and economic burden. To explore social inequalities in somatic symptom severity (SSS) and to identify social groups with highest SSS, we applied an intersectional research approach. Analyses are based on cross-sectional data of the adult population living in Germany (N = 2413). SSS was assessed with the Somatic Symptom Scale-8. A multiple linear regression model with three-way interaction of gender, income and history of migration and post-hoc pairwise comparison of estimated marginal means was conducted. Analyses revealed intersectional inequalities in SSS along the axis of gender, income, and history of migration. Highest SSS was found in males with low income whose parent(s) immigrated, females with low income who immigrated themselves, and females with low income and no history of migration. Intersectional approaches contribute to a more comprehensive understanding of health disparities. To reduce disparities in SSS, proportionate universal interventions combining universal screening and targeted treatment seem promising.

Psychological risk factors of somatic symptom disorder: A systematic review and meta-analysis of cross-sectional and longitudinal studies.

OBJECTIVE: Current 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. METHODS: Psychological 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. RESULTS: Forty-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. CONCLUSION: This 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.

Public knowledge and beliefs about the irritable bowel syndrome - results from the SOMA.SOC study.

BACKGROUND: Despite the epidemiological and economic relevance of the irritable bowel syndrome (IBS), there is a lack of research on what the general public knows and thinks about this condition (IBS literacy). Therefore, the aim of this study was to explore public knowledge and beliefs about IBS in Germany. Moreover, associations of knowledge and beliefs about IBS with socio-demographic characteristics as well as illness and treatment experiences were analysed. METHODS: Analyses made use of a national telephone survey (N = 1,205). A carefully developed vignette describing a person with typical symptoms of IBS was presented. Respondents were then asked to name the disease in question and beliefs about causes and treatment options were assessed. For the analyses respondents were divided into three groups: (1) people who never had IBS symptoms, (2) people who had or have IBS symptoms but never were in treatment and (3) individuals who reported to be or have been treated for IBS symptoms. RESULTS: Less than 4% of the respondents recognized IBS after presentation of the vignette. About 75% positively evaluated treatability while psychotherapy was evaluated more effective than medication. Stress and unhealthy lifestyle were the most frequently endorsed possible causes of the presented IBS symptoms. There were variations in knowledge and beliefs about IBS according to age, gender, and education. We found minor differences in beliefs and knowledge between individuals who had or have symptoms but never were in treatment and those without respective illness experience. Respondents with illness/treatment experiences rated their knowledge significantly better than those without any experiences. CONCLUSIONS: Results indicate low levels of public knowledge about IBS regarding illness recognition in Germany. A majority disagreed that they have good knowledge about IBS symptoms. Against this background, it seems reasonable to develop and test interventions to improve IBS literacy by increasing knowledge about symptoms, causes and treatment options.