Depression and anxiety among nurses during the COVID-19 pandemic: Longitudinal results over 2 years from the multicentre VOICE-EgePan study.

AIMS: To examine symptoms of depression and generalised anxiety among nurses over 2 years during the pandemic and compare them to the general population. BACKGROUND: The COVID-19 pandemic has led to a significant increase in mental stress among the population worldwide. Nursing staff have been identified as being under remarkable strain. DESIGN: A multicentre prospective longitudinal study. METHODS: Symptoms of depression and generalised anxiety in 507 nurses were examined at four different time points (T1: April-July 2020, T2: November 2020-January 2021, T3: May-July 2021, T4: February-May 2022). Results were compared with values of the German general population, presence of gender-specific differences was analysed and frequencies of clinically relevant levels of depression and anxiety were determined. RESULTS: Throughout the study (T1-T4), a significant increase in depressive and anxiety symptoms was observed. At all four measurement time points, nurses showed significantly higher prevalence for depression and anxiety compared to the German general population. No significant gender differences were found. Frequencies for probable depression and generalised anxiety disorder among nurses were: 21.6% and 18.5% (T1), 31.4% and 29.2% (T2), 29.5% and 26.2% (T3), 33.7% and 26.4% (T4). CONCLUSION: During the pandemic, symptoms of depression and generalised anxiety among nurses increased significantly and remained elevated. Their symptom levels were permanently higher than in the general population. These findings strongly suggest that the circumstances of the pandemic severely affected nurses´ mental health. RELEVANCE TO CLINICAL PRACTICE: The COVID-19 pandemic caused a great mental strain on caregivers. This study was able to demonstrate the significant increase in depression and anxiety among nurses during the pandemic. It highlights the urgent need for prevention, screening and support systems in hospitals. IMPLICATIONS FOR THE PROFESSION: Supportive programmes and preventive services should be developed, not least to prevent the growing shortage of nurses in the health care systems. REPORTING METHOD: The study adhered to relevant EQUATOR guidelines. The STROBE checklist for cohort study was used as the reporting method. PATIENT CONTRIBUTION: Five hundred and seven nurses completed the questionnaire and provided data for analysis. TRIAL AND PROTOCOL REGISTRATION: The study was registered with the German Clinical Trials Register (https://drks.de/search/en) under the following ID: DRKS00021268.

Type D Personality as a Risk Factor for Adverse Outcome in Patients With Cardiovascular Disease: An Individual Patient-Data Meta-analysis.

OBJECTIVE: Type D personality, a joint tendency toward negative affectivity and social inhibition, has been linked to adverse events in patients with heart disease, although with inconsistent findings. Here, we apply an individual patient-data meta-analysis to data from 19 prospective cohort studies ( N = 11,151) to investigate the prediction of adverse outcomes by type D personality in patients with acquired cardiovascular disease. METHOD: For each outcome (all-cause mortality, cardiac mortality, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, major adverse cardiac event, any adverse event), we estimated type D's prognostic influence and the moderation by age, sex, and disease type. RESULTS: In patients with cardiovascular disease, evidence for a type D effect in terms of the Bayes factor (BF) was strong for major adverse cardiac event (BF = 42.5; odds ratio [OR] = 1.14) and any adverse event (BF = 129.4; OR = 1.15). Evidence for the null hypothesis was found for all-cause mortality (BF = 45.9; OR = 1.03), cardiac mortality (BF = 23.7; OR = 0.99), and myocardial infarction (BF = 16.9; OR = 1.12), suggesting that type D had no effect on these outcomes. This evidence was similar in the subset of patients with coronary artery disease (CAD), but inconclusive for patients with heart failure (HF). Positive effects were found for negative affectivity on cardiac and all-cause mortality, with the latter being more pronounced in male than female patients. CONCLUSION: Across 19 prospective cohort studies, type D predicts adverse events in patients with CAD, whereas evidence in patients with HF was inconclusive. In both patients with CAD and HF, we found evidence for a null effect of type D on cardiac and all-cause mortality.

Caring for dependent children impacts practical and emotional problems and need for support, but not perceived distress among cancer patients.

OBJECTIVE: More than one in 10 cancer patients care for dependent children. It is unclear whether this status makes a difference in terms of the distress and associated problems they experience, or whether it is linked to differences in the need for or utilization of psychosocial support. METHODS: Secondary analysis of a cross-sectional German study in National Comprehensive Cancer Centers using self-report standardized questionnaires administered to inpatients. Patients living with dependent children (n = 161) were matched by age and sex with a subsample of 161 cancer patients not living with dependent children. The resulting sample was tested for between-group differences in Distress Thermometer (DT) scores and the corresponding DT Problem List. Additionally, between-group differences in measures of the need for and utilization of psychosocial support were examined. RESULTS: More than 50% of all patients suffered from clinically relevant distress. Patients living with dependent children reported significantly more practical (p < 0.001, η2 p = 0.04), family (p < 0.001, η2 p = 0.03), and emotional problems (p < 0.001, η2 p = 0.01). Although reporting a greater need for psychological support, parents with cancer were not found to more frequently utilize any type of psychosocial support. CONCLUSIONS: The specific problems and needs of parents with cancer who care for dependent children are currently not sufficiently addressed in the clinical care pathways. All families should be helped to establish open and honest communication as well as understand the available support systems and what they can provide. Tailored interventions should be implemented for highly distressed families.

What Kind of Patients Receive Inpatient and Day-Hospital Treatment in Departments of Psychosomatic Medicine and Psychotherapy in Germany?

INTRODUCTION: Germany is one of the few countries with a medical specialty of psychosomatic medicine and psychotherapy and many treatment resources of this kind. OBJECTIVE: This observational study describes the psychosomatic treatment programs as well as a large sample of day-hospital and inpatients in great detail using structured diagnostic interviews. METHODS: Mental disorders were diagnosed according to ICD-10 and DSM-IV by means of Mini-DIPS and SCID-II. In addition to the case records, a modified version of the CSSRI was employed to collect demographic data and service use. The PHQ-D was used to assess depression, anxiety, and somatization. RESULTS: 2,094 patients from 19 departments participated in the study after giving informed consent. The sample consisted of a high proportion of "complex patients" with high comorbidity of mental and somatic diseases, severe psychopathology, and considerable social and occupational dysfunction including more than 50 days of sick leave per year in half of the sample. The most frequent diagnoses were depression, somatoform and anxiety disorders, eating disorders, personality disorders, and somato-psychic conditions. CONCLUSIONS: Inpatient and day-hospital treatment in German university departments of psychosomatic medicine and psychotherapy is an intensive multimodal treatment for complex patients with high comorbidity and social as well as occupational dysfunction.

Mental distress of physicians in the outpatient care throughout the COVID-19 pandemic: emotional and supportive human relations matter - Cross-sectional results of the VOICE-study.

BACKGROUND: The aim of this cross-sectional study was to evaluate the course of self-reported mental distress and quality of life (QoL) of physicians, working in the outpatient care (POC). Outcomes were compared with a control group of physicians working in the inpatient care (PIC), throughout the Corona Virus Disease (COVID)-19 pandemic. The impact of risk and protective factors in terms of emotional and supportive human relations on mental distress and perceived QoL of POC were of primary interest. METHODS: Within the largest prospective, multi-center survey on mental health of health care workers (HCW), conducted during the first (T1) and second (T2) wave of the COVID-19 pandemic in Europe, we investigated the course of current burden (CB), depression (Patient Health Questionnaire-2), anxiety (Generalized Anxiety Disorder-2) and QoL, cross-sectionally, in n = 848 POC (T1: n = 536, T2: n = 312). The primary outcomes were compared with an age- and gender-matchted control group of n = 458 PIC (T1: n = 262, T2: n = 196). COVID-19-, work-related, social risk and protective factors were examined. RESULTS: At T1, POC showed no significant differences with respect to CB, depression, anxiety, and QoL, after Bonferroni correction. Whereas at T2, POC exhibited higher scores of CB (Cohen´s d/ Cd = .934, p < .001), depression (Cd = 1.648, p < 001), anxiety (Cd = 1.745, p < .001), work-family conflict (Cd = 4.170, p < .001) and lower QoL (Cd = .891, p = .002) compared with PIC. Nearly all assessed parameters of burden increased from T1 to T2 within the cohort of POC (e.g. depression: CD = 1.580, p < .001). Risk factors for mental distress of POC throughout the pandemic were: increased work-family conflict (CB: ß = .254, p < .001, 95% CI: .23, .28; PHQ-2: ß = .139, p = .011, 95% CI: .09, .19; GAD-2: ß = .207, p < .001, 95% CI: .16, .26), worrying about the patients´ security (CB: ß = .144, p = .007, 95% CI: .07, .22; PHQ-2: ß = .150, p = .006, 95% CI: .00, .30), fear of triage situations (GAD-2: ß = .132, p = .010, 95% CI: -.04, .31) and burden through restricted social contact in spare time (CB: ß = .146, p = .003, 95% CI: .07, .22; PHQ-2: ß = .187, p < .001, 95% CI: .03, .34; GAD-2: ß = .156, p = .003, 95% CI: -.01, .32). Protective factors for mental distress and QoL were the perceived protection by local authorities (CB: ß = -.302, p < .001, 95% CI: -.39, -.22; PHQ-2: ß = -.190, p < . 001, 95% CI: -.36, -.02; GAD-2: ß = -.211, p < .001, 95% CI: -.40, -.03; QoL: ß = .273, p < .001, 95% CI: .18, .36), trust in colleagues (PHQ-2: ß = -.181, p < .001, 95% CI: -.34, -.02; GAD-2: ß = -.199, p < .001, 95% CI: -.37, -.02; QoL: ß = .124, p = .017, 95% CI: .04, .21) and social support (PHQ-2: ß = -.180, p < .001, 95% CI: -.22, -.14; GAD-2: ß = -.127, p = .014, 95% CI: -.17, -.08; QoL: ß = .211, p < .001, 95% CI: .19, .23). CONCLUSIONS: During the pandemic, the protective role of emotional and supportive human relations on the mental distress and quality of life of POC should be taken into account more thoroughly, both in practice and future research.

Effects of Post-awakening Light Exposure on Heart Rate Variability in Healthy Male Individuals.

Light-induced effects on the autonomic nervous system (ANS) are assumed to be mediated by retinal projections to the hypothalamic suprachiasmatic nucleus (SCN) via different routes. Light information for the circadian system is detected by a subset of intrinsically photosensitive retinal ganglion cells (ipRGCs), however, inconsistency exists in research concerning the effects of light exposure on heart rate variability (HRV). Two within-subject experiments were conducted in a standardized sleep laboratory to investigate effects of light intensity (study I, n = 29: 2 days dim vs. bright light) and spectral composition (study II, n = 24: 3 days using red vs. blue vs. green light) on HRV parameters (RMSSD, LF, HF-HRV, LF/HF ratio). Light exposure was conducted for one-hour in the post-awakening phase at 5:00 AM. Results revealed no significant light intensity effect comparing dim light versus bright white light on HRV parameters. Light color of different wavelengths significantly influenced all HRV parameters except the low frequency, with moderate to large effect sizes. RMSSD values were elevated for all three colors compared to norm values, indicating stronger parasympathetic activation. LED light of different spectral compositions demonstrated bidirectional effects on spectral components of the HRV. Red light decreased the LF/HF ratio within 30 min, whereas with blue light, LF/HF ratio consistently increased across 40 min of light exposure.

Validity of a German Comprehensive Psychosocial Screening Instrument based on the ESC Cardiovascular Prevention Guidelines.

Background: Following guidelines for cardiovascular disease prevention of the European Society for Cardiology (ESC), the current study validated the German Comprehensive Psychosocial Screening Instrument in participants who underwent coronary angiography. Methods: 314 participants (Mage = 69.7 ± 12.0; 69 % male) completed the German Comprehensive Psychosocial Screening Instrument and validated comparison scales to measure depression (PHQ-9), anxiety (GAD-7), Type D personality (DS14), work stress (ERI), family stress (SMSS), trauma (PC-PTSD), and anger and hostility (Z-scale of MMPI-2). Results: Confirmatory factor analysis (CFA) confirmed that the psychosocial risk factors were separate entities rather than a signs or symptoms of a single broad indication of distress (CFI = .872, RMSEA = .056, SRMR = .058). Intraclass coefficients (ICC), kappa and diagnostic accuracy indicators (receiver operator characteristic [ROC] curves, sensitivity, specificity, and the positive and negative predictive values [PPV; NPV]) indicated that most screener scales were sufficient to good. We also compared patients with established coronary heart disease (CHD; n = 213) to those with no current CHD (n = 100) and found overall similar results. Discussion: The German version of the Comprehensive Psychosocial Screening Instrument has an acceptable performance. Aside from minor improvements, the screening instrument could be implemented in the cardiological practice to screen patients on multidimensional psychosocial risk.

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.

The psychological consequences of living with coronary heart disease: Are patients' psychological needs served? A mixed-method study in Germany.

INTRODUCTION: This mixed-method study explores psychological needs, access and barriers in coronary heart disease (CHD) patients with and without mental health issues (MHI) within the German healthcare system. METHODS: This study was conducted in three different healthcare settings: two hospitals, two rehabilitation clinics and three cardiology practices in Cologne, Germany. Patients were screened for angiographically documented CHD and other inclusion criteria. In total, 364 CHD patients took part in this study. It consisted of two parts: In the first part, participants filled in a newly developed questionnaire about their psychological needs, access and barriers within the healthcare system and their contact with their doctor in these matters. Then, patients were screened for MHIs with the help of the Hospital Anxiety and Depression Scale (HADS). When a score above seven was scored on the HADS, patients were additionally screened for specific MHIs using the Structured Clinical Interview for DSM-IV Axis I Disorders. In the second part, 20 participants were subsequently interviewed in a semi-structured interview to generate more in-depth findings. RESULTS: The interviews show that CHD patients with and without MHI experienced a cardiac event as life-changing and had an urgent need to talk about CHD with their doctor, mostly the general practitioner (GP). When the GP spoke to the patient shortly after the cardiac event, patients experienced relief and were better able to cope with their illness. Only 9.1% reported being aided in their search for psychotherapeutic treatment or drug treatment (4.1%). CONCLUSION: The needs of CHD patients with and without MHI were not adequately satisfied within our sample. Psychological measures are necessary for sufficient improvement, such as training of doctors in doctor-patient communication (e.g., better support in coping with MHI/CHD), improvements in the procedure (more time for conversations during doctor contacts), and improvement of structural requirements (referring patients faster to psychotherapists). PATIENT OR PUBLIC CONTRIBUTION: We received input from patients during pretests and used the feedback to tailor our questionnaire and the interview guidelines. Afterwards, we disseminated the main results for the patient and public involvement (e.g., public lectures, leaflets for self-help groups, etc.).

[Vaccination willingness against COVID-19 among healthcare workers in Germany : Results from a University Medicine Network survey between November 2020 and January 2021]. / Bereitschaft zur COVID-19-Impfung unter Beschäftigten im Gesundheitswesen in Deutschland : Befragungsergebnisse aus dem Netzwerk Universitätsmedizin (NUM), November 2020 bis Januar 2021.

BACKGROUND: The COVID-19 pandemic is a continuing burden on society and the health system. The vaccination willingness among healthcare workers is of particular interest, as these groups play a key role in the pandemic response. OBJECTIVES: The present study investigated how the willingness of healthcare workers in Germany to get vaccinated depends on sociodemographic, occupational, and COVID-19-specific characteristics, as well as mental health. METHODS: Between November 2020 and January 2021, 6217 employees in the German healthcare system were questioned about their vaccination willingness, sociodemographic, occupational, COVID-19-specific, and psychosocial characteristics using the online VOICE survey within the framework of the University Medicine Network (NUM). RESULTS: The vaccination willingness of the sample group was 65.3%. A higher vaccination willingness was associated with male gender; age > 40 years; having no children or no migration background; not working in direct patient care; belonging to a COVID-19 risk group or professional group of physicians and psychologists in comparison with nursing staff; feeling sufficiently informed about COVID-19 and protected by the measures of the national or local authorities and the employer; fear of infection; and lack of signs of depression. Physicians showed the highest willingness to get vaccinated. CONCLUSIONS: During the study period, an overall moderate vaccination willingness against COVID-19 in the health sector was described. Information about the disease and vaccination, especially for younger people, females, and non-physicians, adequate protective measures and prevention of depressive symptoms could increase the vaccination willingness.

[egePan-VOICE study on the psychosocial burden of the Covid-19 pandemic among - medical technical assistants]. / egePan-VOICE-Studie zur psychosozialen Belastung durch die Covid-19-Pandemie bei medizinischtechnischen Assistent*innen.

egePan-VOICE study on the psychosocial burden of the Covid-19 pandemic among - medical technical assistants Objectives: The Covid-19 pandemic is associated with increased demands on healthcare workers. A previously neglected occupational group is medical technical assistants (MTA). The aim is therefore to identify stress factors among MTA in Germany during the pandemic. Methods: A cross-sectional online survey of medical staff was conducted in spring 2020 (N = 8088). Results: N = 1483 records of MTA were analyzed. Retrospectively, the stress increased under the pandemic, and 60.1 % of MTA suffered from work stress (ERI). Staff shortages and extra work were associated with an increase in work stress. Problems of work-life balance and contact with contaminated material/infected persons favored stressful experiences. Conclusions: Some working conditions in the pandemic pose a potential health risk to MTA. It seems necessary to create improvements in the general conditions that enable healthily and effective work.

Increase in cortisol concentration due to standardized bright and blue light exposure on saliva cortisol in the morning following sleep laboratory.

Research studies on LED light exposure and cortisol are inconsistent and not comparable due to different types of light, exposure times, and sample sizes. Therefore, one hour of standardized exposure LED light at different intensities and the spectral composition during the post-awakening phase at 7:30 were compared. A sample of 23 (Study 1) and 26 (Study 2) healthy males were randomly assigned to: 1) bright white light (414 lux) and 2) dim darkened light (<2 lux) as well as 3) red light (235 lux) and 4) blue light (201 lux) exposure conditions. Results from repeated measures ANOVA confirm that light exposure affects the cortisol concentration. Study 1 revealed an increase in the saliva cortisol concentration after bright light exposure compared to dim light. An increase in the cortisol concentration of blue light compared to red light (Study 2) and dim light was found. This study shows that bright light and blue light affect the cortisol response in contrast to dim light and red light conditions. The HPA axis showed a stimulatory effect by bright versus dim light and different wavelengths of light exposure.Lay summaryThe effects of LED light exposure on the stress hormone cortisol were investigated. The light exposure took place during the hours people would start working at the office. The results showed that after one hour of exposure to bright light or blue light the stress hormones increase in contrast to dim light and red light conditions. Thus, stress hormones can be altered by the types of light people are exposed to.

Effect of acute psychosocial stress on the brain-derived neurotrophic factor in humans - a randomized cross within trial.

The brain-derived neurotrophic factor (BDNF) is involved in the plasticity and development of the central nervous system. Thereby the protein synthesis is highly related to neuronal activity, and its signaling pathways are associated with several substances like, e.g. glucocorticoids, which seem to be able to activate BDNF-Tropomyosin receptor kinase B (TrkB). While there is evidence that acute physical stress can result in advantageous physiological outcomes like an enhanced BDNF level, outcome parameters in response to psychosocial stress are primarily focused on psychological parameters. The existing literature pointing on the impact of acute psychosocial stress on physiological parameters is controversial and differs depending on the species, the stressor used, and the study methodology. It was hypothesized that an acute standardized psychosocial stressor would increase the BDNF level and therefore show beneficial physiological outcome parameters through psychosocial stress. The serum BDNF levels of 32 healthy young males (M = 24.31 years of age, SD = 3.35), who performed the Trier Social Stress Test (TSST), were assessed and compared to a control condition. To prove the stress-generating effect of the TSST, additional cortisol levels were measured. Acute psychosocial stress significantly increased the serum BDNF- and the cortisol-level, whereby no alteration was found during the control. This study expands the rare literature focusing on the effect of an acute standardized psychosocial stressor on the BDNF level in healthy humans, including a control condition. Implications for future studies are being discussed.

[Psychodiabetology]. / Psychodiabetologie.

People affected by diabetes mellitus often have difficulties coping with their condition. This can be further worsened by psychological co-morbidities (e. g., depression or anxiety disorders). Both factors are associated with diabetes-specific problems (e. g., persistent hyperglycaemia, recurrent hypoglycaemia), but also with diabetes complications or comorbid somatic diseases. When psychotherapeutic or psychopharmacological treatment is indicated, it is essential to take into account the particularities of diabetes and the different types of diabetes. This review focuses on adults only and includes a brief description of the clinical features and therapeutic goals in diabetes mellitus. Critical diabetic symptoms that should result in specific interventions (yellow flags) as much as symptoms that require immediate intervention (red flags) are highlighted. Finally, psychological and behavioural factors as well as mental comorbidities that are relevant to the management of diabetes mellitus are discussed.

[Chronic Pain in People Impaired by Thalidomide Embryopathy: An Explorative Analysis of Prevalence, Pain Parameters and Biopsychosocial Factors]. / Chronische Schmerzen bei Menschen mit Thalidomid-Embryopathie Eine explorative Analyse zu Prävalenz, schmerzbezogenen Merkmalen und biopsychosozialen Faktoren.

OBJECTIVE: The aim of the study was to show the frequency, localisation, intensity, quality and degree of chronic pain in people with thalidomide-induced congenital defects (thalidomide embryopathy) and to investigate the association with biopsychosocial factors more closely. METHODS: A group of 202 people from North Rhine-Westphalia with thalidomide embryopathy were studied for the first time both physically for the pattern of the original damage and also psychiatrically in a structured diagnostic interview (SCID I & SCID II). The results were combined with a standardized pain interview (MPSS) and questionnaires on further pain-related (SF-36, painDETECT) and sociodemographic variables and analysed. In the analysis 167 completed datasets were included. RESULTS: The prevalence of pain in the sample population was 94%. The majority (107, 54.0%) already showed an advanced stage of chronicity in the MPSS: 63 subjects with Stage II (37.7%) and 44 with Stage III (26.3%). In 74 subjects (44.3%) the PainDetect score showed a possible or neuropathic pain component. The factors that most reliably influenced the chronicity of pain proved to be hip pain (p<0.001) and also mental health disorders (p=0.001), above major depression (p<0.001) and also somatic symptom disorders and substance-related disorders (p=0.001 in each case). Social variables proved non-significant here (p=0.094 for living alone, p=0.122 for unemployment, p=0.167 for lack of college education), as did the care situation (p=0.191 for care dependency) and the underlying pattern of organ damage (p=0.229 for damage to hearing, p=0.764 for dysmelia). CONCLUSIONS: People with thalidomide defects frequently suffer from a separate pain disorder which can be seen as secondary thalidomide-induced damage and which requires specialized and personalized multimodal pain management.

Efficacy of team-based collaborative care for distressed patients in secondary prevention of chronic coronary heart disease (TEACH): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence. METHODS: In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients' care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18-30 months of follow-up. DISCUSSION: TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824.

Length Polymorphisms in the Angiotensin I-Converting Enzyme Gene and the Serotonin-Transporter-Linked Polymorphic Region Constitute a Risk Haplotype for Depression in Patients with Coronary Artery Disease.

Genetic variations affecting the course of depressive symptoms in patients with coronary artery disease (CAD) have not yet been well studied. Therefore, we set out to investigate whether distinct haplotypes of the two insertion/deletion polymorphisms in the serotonin-transporter-linked polymorphic region (5-HTTLPR) and the angiotensin I-converting enzyme (ACE) gene located on chromosome 17 can be identified as risk factors for trajectories of depression. Clinical and genotyping data were derived from 507 depressed CAD patients participating in the randomized, controlled, multicenter Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD) trial, of whom the majority had an acute cardiac event before study inclusion. Depression scores on the Hospital Anxiety and Depression Scale (HADS) were assessed at baseline and at five follow-up time points up to 2 years after study entrance. At baseline, depression scores did not significantly differ between patients carrying the risk haplotype ACE D/D, 5-HTTLPR I/I (n = 46) and the non-risk haplotypes (n = 461, 10.9 ± 2.7 versus 10.4 ± 2.5, p = 0.254). HADS-depression scores declined from study inclusion during the first year irrespective of the genotype. At each follow-up time point, HADS-depression scores were significantly higher in ACE D/D, 5-HTTLPR I/I carriers than in their counterparts. Two years after study inclusion, the mean HADS depression score remained 1.8 points higher in patients with the risk haplotype as compared to subjects not carrying this haplotype (9.9 ± 4.2 versus 8.1 ± 4.0, p = 0.009). In summary, the presence of the ACE D/D, 5-HTTLPR I/I haplotype may be a vulnerability factor for comorbid depressive symptoms in CAD patients.

Prediction of survival on the waiting list for heart transplantation and of posttransplant nonadherence-Results of a prospective longitudinal study.

BACKGROUND: Only a few previous studies have focused on the interaction between pretransplant psychological variables, survival on the waiting list, and adherence to therapy after heart transplantation (HTx). METHODS: This work combined two studies: Study 1 monitored survival of patients on a HTx waiting list (n = 50) and study 2 examined barriers to adherence after HTx (subgroup of n = 20). All patients were evaluated immediately after listing for HTx (T0). Those in study 2 were also evaluated immediately after HTx (T1) and after 6 months (T2). Psychosocial functioning was measured by the Transplant Evaluation Rating Scale (TERS), and depression and anxiety by Patient Health Questionnaire and Hospital Anxiety and Depression Scale. Barriers to immunosuppressive adherence post-HTx were measured by the Medication Experience Scale for Immunosuppressants (MESI). RESULTS: According to the TERS classification of Rothenhäusler et al, patients were divided into three groups in study 1. Compared with inconspicuous patients (n = 23) and risk patients (n = 21), high-risk patients (n = 6) demonstrated a higher mortality (log-rank test of trend, P = 0.002). In study 2, there was a strong correlation between the TERS (T0) and the MESI (T2) (r = 0.84, P = 0.001). CONCLUSIONS: The TERS may serve as a predictor of survival on the waiting list. There is need for further longitudinal data with larger sample sizes.

Somatic and sociodemographic predictors of depression outcome among depressed patients with coronary artery disease - a secondary analysis of the SPIRR-CAD study.

BACKGROUND: Depressive symptoms are common in patients with coronary artery disease (CAD) and are associated with an unfavourable outcome. Establishing prognostic patient profiles prior to the beginning of mental health care may facilitate higher efficacy of targeted interventions. The aim of the current study was to identify sociodemographic and somatic predictors of depression outcome among depressed patients with CAD. METHODS: Based on the dataset of the multicentre SPIRR-CAD randomised controlled trial (n = 570 patients with CAD and ≥ 8 points on the Hospital Anxiety and Depression Scale (HADS)), 141 potential sociodemographic and somatic predictors of the change in the HADS-D depression score from baseline to 18-month-follow-up were derived in two different ways. We screened for univariable association with response, using either analysis of (co)variance or logistic regression, respectively, both adjusted for baseline HADS-D value and treatment group. To guard against overfitting, multivariable association was evaluated by a linear or binomial (generalised) linear model with lasso regularisation, a machine learning approach. Outcome measures were the change in continuous HADS-D depression scores, as well as three established binary criteria. The Charlson Comorbidity Index (CCI) was calculated to assess possible influences of comorbidities on our results and was also entered in our machine learning approach. RESULTS: Higher age (p = 0.002), unknown previous myocardial infarction (p = 0.013), and a higher heart rate variability during numeracy tests (p = .020) were univariably associated with a favourable depression outcome, whereas hyperuricemia (p ≤ 0.003), higher triglycerides (p = 0.014), NYHA class III (p ≤ 0.028), state after resuscitation (p ≤ 0.042), intake of thyroid hormones (p = 0.007), antidiabetic drugs (p = 0.015), analgesic drugs (p = 0.027), beta blockers (p = 0.035), uric acid drugs (p ≤ 0.039), and anticholinergic drugs (p = 0.045) were associated with an adverse effect on the HADS-D depression score. In all analyses, no significant differences between study arms could be found and physical comorbidities also had no significant influence on our results. CONCLUSION: Our findings may contribute to identification of somatic and sociodemographic predictors of depression outcome in patients with CAD. The unexpected effects of specific medication require further clarification and further research is needed to establish a causal association between depression outcome and our predictors. TRIAL REGISTRATION: www.clinicaltrials.gov NCT00705965 (registered 27th of June, 2008). www.isrctn.com ISRCTN76240576 (registered 27th of March, 2008).

Life situation of women impaired by Thalidomide embryopathy in North Rhine-Westphalia - a comparative analysis of a recent cross-sectional study with earlier data.

BACKGROUND: Between 1957 and 1961 the substance Thalidomide was sold in West Germany and taken by many women as a sedative during pregnancy. This lead to miscarriages and infants been born with several severe malformations. The aim of this study was to describe the current situation of women impaired by Thalidomide induced embryopahty in North Rhine-Westphalia (Nordrhein-Westfalen), Germany, in comparison with the results found in a study done in 2002 by Nippert et al. METHODS: Questionnaires as well as examinations were performed. Data were compared using descriptive and inductive statistical methods. RESULTS: Both studies show that women impaired by Thalidomide embryopathy face a poorer health status than women their age in the general population and live in fear of further deteriorating health. The majority can only work reduced hours or are already retired due to poor health. Most of those who need assistance are being assisted by their social environment, while professional care is still utilized in only few cases. CONCLUSIONS: An obvious need for a shift in the provision of assistance and/or care provided was found as the social environment supporting the impaired women is also aging and therefore in high danger of breaking apart. TRIAL REGISTRATION: The study has been registered at German Clinical Trials Register, DRKS00010593 , on 07.06.2016 retrospectively.