Outcomes with ibrutinib in patients with chronic lymphocytic leukaemia: Results from the German multicentre REALITY study.

OBJECTIVES: To assess treatment adherence, effectiveness and safety outcomes of patients with chronic lymphocytic leukaemia (CLL) receiving ibrutinib in a real-world setting. METHODS: Patients enrolled in REALITY were ≥18 years with a confirmed diagnosis of CLL and were receiving ibrutinib as a first-line (1L), 2L or ≥3L therapy. Treatment retention, adherence, progression-free survival (PFS), overall survival (OS) and time to next therapy were assessed at 1 and 2 years overall, by typology and by cytogenetic subgroups. PFS and OS were analysed using Kaplan-Meier methods. RESULTS: Exactly 302 patients were enrolled across 57 sites in Germany, from January 2017 to July 2021. One-year retention rates were 69.9% overall (primary endpoint), 77.9% for 1L patients, and 77.6%/78.8% for high-risk patients with del17p/TP53. At 2 years, PFS/OS rates were 77.8%/90.7% overall (1L, 82.7%/90.4%), and were consistent across cytogenetic subgroups. PFS rates were higher for 1L versus ≥3L patients. Patients with the low-acceptance/low-control typology at baseline were less likely to retain treatment at 1 year versus the high-acceptance/high-control typology. No new safety signals were observed. CONCLUSIONS: The REALITY study provides further evidence of the effectiveness and safety of ibrutinib in patients with CLL in a real-world setting, particularly in earlier treatment lines.

Originalbeiträge (Originals). Zur klinischen Bedeutung reduzierter Exekutivfunktionen bei älteren Patient:innen mit psychischen Erkrankungen©.

On the clinical significance of reduced executive functions in elderly patients with mental illnesses Research question: Executive functions (EF) show increasing deficits in old age.There are also numerous studies demonstrating the importance of EF in relation to depression, anxiety disorders and post-traumatic stress disorder in older patients. METHODS: The study presented examined this question in a sample of patients in a psychosomatic clinic who were in middle (< 60years) and older age (≥ 60years) (N = 150) and compared them with a psychologically non-stressed comparison sample (N = 157).The survey instrument used to assess EF was the Trail-Making Test (TMT). RESULTS: The results show age and setting differences, i. e. older as well as mentally ill subjects showed worse results; an interaction effect was also found. Associations of symptoms and EF were found only in the elderly sample, but not in the middle-aged sample. CONCLUSIONS: The results show that the importance of impaired executive functions is a clinically relevant variable in psychotherapy of the elderly.

Accelerometry-assessed sleep clusters and cardiometabolic risk factors in adolescents.

OBJECTIVE: This study aimed to identify sleep clusters based on objective multidimensional sleep characteristics and test their associations with adolescent cardiometabolic health. METHODS: The authors included 1090 participants aged 14.3 to 16.4 years (mean = 15.2 years) who wore 7-day accelerometers during the 15-year follow-up of the German Infant Study on the influence of Nutrition Intervention PLUS environmental and genetic influences on allergy development (GINIplus) and the Influence of Lifestyle factors on the development of the Immune System and Allergies in East and West Germany (LISA) birth cohorts. K-means cluster analysis was performed across 12 sleep characteristics reflecting sleep quantity, quality, schedule, variability, and regularity. Cardiometabolic risk factors included fat mass index (FMI), blood pressure, triglycerides, high-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and insulin resistance (n = 505). Linear and logistic regression models were examined. RESULTS: Five sleep clusters were identified: good sleep (n = 337); delayed sleep phase (n = 244); sleep irregularity and variability (n = 108); fragmented sleep (n = 313); and prolonged sleep latency (n = 88). The "prolonged sleep latency" cluster was associated with increased sex-scaled FMI (ß = 0.39, 95% CI: 0.15-0.62) compared with the "good sleep" cluster. The "sleep irregularity and variability" cluster was associated with increased odds of high triglycerides only in male individuals (odds ratio: 9.50, 95% CI: 3.22-28.07), but this finding was not confirmed in linear models. CONCLUSIONS: The prolonged sleep latency cluster was associated with higher FMI in adolescents, whereas the sleep irregularity and variability cluster was specifically linked to elevated triglycerides (≥1.7 mmol/L) in male individuals.

Practice patterns, experiences, and challenges of German oncology health care staff with smoking cessation in patients with cancer: a cross-sectional survey study.

PURPOSE: Often, cancer patients do not receive education about the negative consequences of smoking on the treatment outcome. To support cancer patients in the process of smoking cessation, it is essential to involve oncology staff. This study aims to learn about the experiences and attitudes from the point of view of oncology staff and, thus, how a smoking intervention should be designed. The study aims to engage all oncology staff due to the unclear responsibility for providing smoking cessation education, support, and motivating cancer patients to quit smoking. METHODS: N = 354 German oncology staff (oncologists, nurses, psycho-oncologists, others) filled out a 5-point Likert scale-based questionnaire regarding practices, potential barriers, and attitudes towards smoking cessation between October 2021 and June 2022. The questionnaire was developed by Derksen et al. (2020), translated and slightly modified for the use of this study. It was distributed to all leading oncology staff in our Cancer Center Network with a request to share with all oncology staff. Flyers were also handed out in all oncology wards and outpatient clinics in the same Cancer Center Network. RESULTS: Most oncology staff ask cancer patients about their current smoking status (curative, M = 2.27; SD = 1.59; palliative, M = 2.90; SD = 1.83), but they rarely treat or refer patients for a smoking cessation intervention (curative, M = 4.78; SD = 1.20; palliative, M = 4.99; SD = 1.06). Smoking behavior of curative cancer patients is addressed more than that of palliative cancer patients (d = - 37). Regression analyses of key dependent variables showed that profession, setting, and the belief that continued smoking affects treatment outcome explained the variance of asking patients if they smoke, advising to stop smoking and lack of time (without profession). CONCLUSION: Involving oncology staff in motivating cancer patients who smoke to quit and referring them to smoking cessation services should take the different attitudes and knowledge of the staff into account to improve treatment that supports tobacco cessation. IMPLICATIONS FOR CANCER SURVIVORS: Cancer patients have special needs when it comes to a cessation program. In the long term, survivors will benefit from tailored smoking cessation education and services provided by oncology staff to help them quit smoking after a cancer diagnosis.

Specialist palliative care until the very end of life - reports of family caregivers and the multiprofessional team.

BACKGROUND: Specialist palliative care (SPC) includes care for incurably ill patients and their family caregivers at home or on a palliative care ward until the very end of life. However, in the last days of life, patients can rarely express their needs and little is known about SPC outcomes as reported by multiprofessional SPC teams and family caregivers. METHODS: Using the Palliative Care Outcome Scale (POS; Score 0-40), proxy assessments of SPC outcomes in the patient's last 3 days of life were performed by SPC teams and primary family caregivers of three home care and three inpatient services. Additional questions were asked about problems solved 'particularly well' or 'inadequately' (last 7 days), which were content analyzed and quantified. RESULTS: Proxy assessments by SPC teams were available in 142 patients (of whom 51% had died at home). Family caregiver assessments exist for a subgroup of 60 of these patients. SPC teams (POS total score: mean 13.8, SD 6.3) reported SPC outcomes slightly better than family caregivers (mean 16.7, SD 6.8). The POS items consistently rated as least affected (= 0) by both, SPC teams and family caregivers, were 'not wasted time' (team 99%/family caregivers 87%), 'information' (84%/47%) and 'support' (53%/31%). Items rated as most affected (= 4) were 'patient anxiety' (31%/51%), 'life not worthwhile' (26%/35%) and 'no self-worth' (19%/30%). Both groups indicated more problems solved 'particularly well' than 'inadequately'; the latter concerned mainly clinically well-known challenges during end-of-life care and family caregiver care. CONCLUSIONS: This study shows the range and type of symptoms and other concerns reported in the patient's last days. Starting points for further improvements in family caregiver care and psychosocial and spiritual issues were identified.

Barriers and needs in mental healthcare of adults with autism spectrum disorder in Germany: a qualitative study in autistic adults, relatives, and healthcare providers.

BACKGROUND: Autism refers to a neurodevelopmental condition with characteristic impairments in social interaction and communication, restrictive and repetitive behaviors, as well as difficulties in sensory information processing and daily living skills. Even though symptoms persist from early childhood throughout the lifespan and often require long-term support, there is a lack of mental health services that sufficiently meet the needs of autistic adults. Previous evidence suggested individual, professional and structural barriers to healthcare for autistic adults. Here, using a peer research approach, we sought to systematically investigate barriers and needs in mental healthcare of autistic adults in Germany at the three relevant levels (individual, professional, structural) and from three relevant perspectives (autistic adults, relatives and healthcare providers), in order to obtain specific recommendations for optimized healthcare. METHODS: Maximum variation sampling was used to account for the complexity of the research field. Semi-structured, open-ended interviews were conducted with autistic adults (n = 15) and focus groups with relatives/partners (n = 12), and healthcare providers of several professions (n = 15). Data analysis was performed using the codebook approach of thematic analysis. RESULTS: Poor mental healthcare of autistic adults in Germany was characterized by six central and overarching themes: (i) lack of knowledge about autism, (ii) a need for increased participation/involvement, (iii) consideration of autism-specific needs in treatment, (iv) lack of services, (v) limited access to services, and (vi) improvement of stakeholder collaboration. Themes were similarly reported across participants, emphasizing dissatisfaction in all stakeholders. CONCLUSIONS: We identified major barriers to mental healthcare for autistic adults in Germany that affect autistic adults, but are also of concern to relatives and healthcare providers. Our results point to specific and generic areas for improvement, independent of stakeholder perspectives, which could guide future development of needs- and evidence-based services, recommendations and guidelines of mental healthcare for people with autism across the lifespan. TRIAL REGISTRATION: This study protocol was preregistered at the Open Science Framework ( https://osf.io/5x8pg ).

Adipose tissue is associated with kidney function parameters.

Obesity is characterized by the accumulation of adipose tissue in different body compartments. Whether adipose tissue directly affects kidney function is still unknown. We aimed to investigate the role of the adipose tissue and circulating creatinine, cystatin C and kidney function in subjects free of cardio-renal diseases. In the KORA-MRI population-based study, 377 subjects (mean age 56.2 ± 9.2 years; 41.6% female) underwent whole-body 3T-MRI examination. Adipose tissue defined as visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) were quantified from T1-DIXON sequence using a semi-automatic algorithm. Serum creatinine and cystatin C were measured using standard laboratory and estimated glomerular filtration rate (e-GFR) was performed based on creatinine (e-GFRcrea), cystatin C (e-GFRcys) and creatinine-cystatin C (e-GFRcc). Linear regression analysis, adjusted for risk factors, was used to investigate the relationship between adipose tissue and circulating creatinine, cystatin C, and kidney function. In multivariate analyses VAT was inversely associated with eGFRcys (ß = - 4.88, p = < 0.001), and positively associated with serum cystatin C (ß = 0.05, p = < 0.001), respectively. No association was found between other adipose parameters such as total adipose tissue (TAT) and subcutaneous adipose tissue (SAT) and serum creatinine, urine microalbumin and eGFRcrea. Stratified analyses according to BMI revealed confirmatory results for category of BMI > 30. VAT is positively associated with serum cystatin C and inversely with eGFR based on cystatin C, suggesting a direct involvement of visceral adipose tissue in increased metabolism of cystatin C and consequently decreased kidney function.

Evaluation of a short instrument for measuring health-related quality of life in oncological patients in routine care (HELP-6): an observational study.

Purpose: Patient-reported outcomes have not been sufficiently implemented into the routine care of cancer patients because the existing instruments are often too long and complex or not cancer-specific. The aim of this study is the determination of psychometric properties and item reduction of a newly developed health-related quality of life (HrQoL) questionnaire for use in oncological clinical routines. Methods: This observational study with a repeated measurements design included oncological inpatients and outpatients. A total of 630 patients participated at the first point of measurement and 404 at the second point of measurement. To evaluate the instrument, we conducted hierarchical confirmative factor analyses and for further validation correlated the resulting factors with standardized and validated HrQoL measurements. Test-retest reliability and responsiveness to change were tested. Results: The developed questionnaire "HELP-6" ("Hamburg Inventory for Measuring Quality of Life in Oncological Patients") has a six-factor structure and has moderate-to-good convergent validity (r= -0.25 --0.68). Test-retest reliability was moderate-to-good (r =0.56-0.81, p < 0.001). Indications for responsiveness to change were found for three dimensions. The final version of the questionnaire HELP-6 has six dimensions with one item each. Conclusion: With the HELP-6 instrument for measuring HrQoL in cancer patients, we provide a short and practical patient-reported outcome instrument. Though responsiveness to change could not be confirmed for all dimensions in this study, the HELP-6 includes time-efficient completion and evaluation and is informative in relevant HrQoL dimensions of cancer patients. Therefore, the HELP-6 poses an important addition to inpatient and outpatient routine cancer care. Trial registration: This study was registered at Open Science Framework (https://osf.io/y7xce/), on 9 June 2018.

Cross-sectional field study comparing hippocampal subfields in patients with post-traumatic stress disorder, major depressive disorder, post-traumatic stress disorder with comorbid major depressive disorder, and adjustment disorder using routine clinical data.

Background: The hippocampus is a central brain structure involved in stress processing. Previous studies have linked stress-related mental disorders, such as post-traumatic stress disorder (PTSD) and major depressive disorder (MDD), with changes in hippocampus volume. As PTSD and MDD have similar symptoms, clinical diagnosis relies solely on patients reporting their cognitive and emotional experiences, leading to an interest in utilizing imaging-based data to improve accuracy. Our field study aimed to determine whether there are hippocampal subfield volume differences between stress-related mental disorders (PTSD, MDD, adjustment disorders, and AdjD) using routine clinical data from a military hospital. Methods: Participants comprised soldiers (N = 185) with PTSD (n = 50), MDD (n = 70), PTSD with comorbid MDD (n = 38), and AdjD (n = 27). The hippocampus was segmented and volumetrized into subfields automatically using FreeSurfer. We used ANCOVA models with estimated total intracranial volume as a covariate to determine whether there were volume differences in the hippocampal subfields cornu ammonis 1 (CA1), cornu ammonis 2/3 (CA2/3), and dentate gyrus (DG) among patients with PTSD, MDD, PTSD with comorbid MDD, and AdjD. Furthermore, we added self-reported symptom duration and previous psychopharmacological and psychotherapy treatment as further covariates to examine whether there were associations with CA1, CA2/3, and DG. Results: No significant volume differences in hippocampal subfields between stress-related mental disorders were found. No significant associations were detected between symptom duration, psychopharmacological treatment, psychotherapy, and the hippocampal subfields. Conclusion: Hippocampal subfields may distinguish stress-related mental disorders; however, we did not observe any subfield differences. We provide several explanations for the non-results and thereby inform future field studies.

Association of the Extent of Internet Use by Patients With Cancer With Social Support Among Patients and Change in Patient-Reported Treatment Outcomes During Inpatient Rehabilitation: Cross-sectional and Longitudinal Study.

BACKGROUND: Given the increasing number of cancer survivors and their rising survival rates, rehabilitation plays an increasingly important role. Social support among patients is an essential element of inpatient and day care rehabilitation. The internet can empower patients with cancer to become more active health care consumers and facilitate information and supportive care needs. By contrast, therapists suspect that high internet use during rehabilitation may severely limit social interactions between patients, thus interfering with the patients' rehabilitation program and jeopardizing treatment success. OBJECTIVE: We hypothesized that the extent of internet use would be negatively related to social support among patients with cancer during their clinical stay as well as fewer improvements in patient-reported treatment outcomes from the first to the last day of their clinical stay. METHODS: Patients with cancer participated during their inpatient rehabilitation. Cross-sectional data, such as the extent of participants' internet use and perceived social support among patients, were collected during the last week of their clinic stay. The treatment outcomes, that is, participants' levels of distress, fatigue, and pain, were collected on the first and last day of the clinic stay. We used multiple linear regression analysis to study the association between the extent of internet use and social support among patients with cancer. We used linear mixed model analyses to study the association between the extent of internet use by patients with cancer and the change in patient-reported treatment outcomes. RESULTS: Of the 323 participants, 279 (86.4%) participants reported that they used the internet. The extent of the internet use (t315=0.78; P=.43) was not significantly associated with the perceived social support among the participants during their clinical stay. In addition, the extent of participants' internet use during their clinical stay was not associated with changes in participants' levels of distress (F1,299=0.12; P=.73), fatigue (F1,299=0.19; P=.67), and pain (F1,303=0.92; P=.34) from the first to the last day of their clinical stay. CONCLUSIONS: The extent of internet use does not seem to be negatively associated with the perceived social support among patients with cancer or with the change in patients' levels of distress, fatigue, or pain from the first to the last day of their clinical stay.

Smoking patterns and the intention to quit in German patients with cancer: study protocol for a cross-sectional observational study.

INTRODUCTION: Patients who continue to smoke cigarettes after a cancer diagnosis can experience poorer treatment tolerance and outcomes than those who quit immediately. Identifying risk factors specific to patients with cancer who smoke, as well as their smoking behaviours (eg, frequency of use, types of tobacco products), dependency level and quit intentions, is necessary to better inform patients and encourage quitting smoking after a cancer diagnosis. This study aims to examine the occurrence of smoking in patients with cancer treated at specialised oncology departments and outpatient clinics based within the metropolitan region of Hamburg, Germany, and presents an analysis of their smoking patterns. This understanding is the first step in developing an adequate smoking cessation intervention and shall contribute to a sustainable improvement in the treatment results, long-term survival and quality of life of patients with cancer. METHODS AND ANALYSIS: A questionnaire will be administered to patients with cancer (N=865) aged 18 years and above in the catchment area of Hamburg, Germany. Data acquisition includes sociodemographic, medical and psychosocial data as well as information on current smoking patterns. To identify the associations between smoking patterns and sociodemographic characteristics, disease-related variables, and psychological risk factors, descriptive statistics and multiple logistic as well as multinomial regressions will be performed. ETHICS AND DISSEMINATION: This study was registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/PGBY8). It was approved by the ethics committee of the local psychological Ethic committee at the centre of psychosocial medicine Hamburg, Germany (LPEK) (tracking number: LPEK-0212). The study will be carried out in accordance with the Code of Ethics of the Declaration of Helsinki. The results will be published in peer-reviewed scientific journals.

Effectiveness of brief psychosocial support for patients with cancer and their relatives: a quasi-experimental evaluation of cancer counselling centres.

OBJECTIVES: The aim of this study was to evaluate the effectiveness of brief psychosocial support for patients with cancer and their relatives regarding their mental health. DESIGN: Quasi-experimental controlled trial with measurements at three time points (baseline, after 2 weeks and after 12 weeks). SETTING: The intervention group (IG) was recruited at two cancer counselling centres in Germany. The control group (CG) included patients with cancer or relatives who did not seek support. PARTICIPANTS: In total, n=885 participants were recruited and n=459 were eligible for the analysis (IG, n=264; CG, n=195). INTERVENTION: One to two psychosocial support sessions (approximately hour) provided by a psycho-oncologist or social worker. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was distress. The secondary outcomes were anxiety and depressive symptoms, well-being, cancer-specific and generic quality of life (QoL), self-efficacy and fatigue. RESULTS: The linear mixed model analysis showed significant differences between IG and CG at follow-up for distress (d=0.36), p=0.001), depressive (d=0.22), p=0.005) and anxiety symptoms (d=0.22), p=0.003), well-being (d=0.26, p=0.002), QoL (QoL mental; d=0.26, p=0.003), self-efficacy (d=0.21, p=0.011) and QoL (global; d=0.27, p=0.009). The changes were not significant for QoL (physical; d=0.04, p=0.618), cancer-specific QoL (symptoms; d=0.13, p=0.093), cancer-specific QoL (functional; d=0.08, p=0.274) and fatigue (d=0.04, p=0.643). CONCLUSION: The results suggest that brief psychosocial support is associated with the improvement of mental health of patients with cancer and their relatives after 3 months. TRIAL REGISTRATION NUMBER: DRKS00015516.

First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Final results of the NEPTUN study.

Real-world data on the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) are still limited. The NEPTUN study evaluated effectiveness and safety of first-line nab-paclitaxel (Abraxane) plus carboplatin (nab-P/C) in patients with advanced NSCLC in routine clinical practice in Germany. Patients included in our study were aged ≥18 years, diagnosed with locally advanced or metastatic NSCLC and with decision for first-line nab-P/C in routine clinical practice. Primary objective was 6-month progression-free survival rate (PFS6), secondary objectives included overall survival (OS), overall response rate (ORR) and safety. From 2016 to 2019, 408 patients from 75 sites were enrolled. PFS6 was 39.5% (95% CI: 34.2-44.8), median PFS was 5.1 months (95% CI: 4.6-5.6), ORR was 42.9% (95% CI: 37.7-48.2). Median OS was 10.5 months (95% CI: 9.2-11.6). In subgroup analyses, median OS for squamous vs non-squamous histology was 11.5 months (95% CI: 9.2-13.8) vs 9.8 months (95% CI: 8.1-11.3) and for patients aged ≥70 vs <70 years median OS was 12.4 months (95% CI: 9.8-15.1) vs 9.6 months (95% CI: 7.7-11.1). Adverse events (AEs) related to nab-paclitaxel were reported in 247 (66.4%) patients, while carboplatin-related AEs were documented in 224 (60.2%) patients. Most frequently related AEs were leukopenia (22.3%) for nab-paclitaxel and anemia (20.2%) for carboplatin. Nab-P/C-related deaths were reported in 2 (0.5%) patients (sepsis and neutropenic sepsis). No new or unexpected safety signals emerged. These results support the effectiveness and safety of first-line nab-P/C in patients with advanced NSCLC reported in the pivotal trial and highlight the clinical value of this regimen in the real-world setting.

Validation of the Recovering Quality of Life (ReQoL) questionnaires for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders in Germany.

The health-related quality of life (HrQoL) and the recovery process of persons with mental health conditions can be assessed with the Recovering Quality of Life questionnaires (ReQoL-20 and ReQoL-10). The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with anxiety, obsessive-compulsive, stress-related, and somatoform disorders and in patients with disorders of adult personality and behavior. This study was based on a sub-sample of patients that were included in a randomized controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). The internal consistency was assessed using Cronbach's Alpha and the test-retest reliability was assessed by the intra-class correlation coefficient (ICC). Concurrent validity was assessed by Pearson's Correlation Coefficient and the known-group validity was assessed using the Cohen's d. The internal consistency of the ReQoL-20 and ReQoL-10 was excellent and good with Cronbach's alpha of α = 0.91 and α = 0.83 for all items. The test-retest reliability of the ReQoL measures was moderate with ICC of r = 0.72 to 0.74. The concurrent validity of the ReQoL measures with the Global Severity Index was overall high with a correlation coefficient of r = -0.70. In conclusion, for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders, the German version of the ReQoL measures is valid and reliable for the assessment of HrQoL and the recovery process.

Psychometric evaluation of the German version of the Recovering Quality of Life (ReQoL) measures in patients with affective disorders.

BACKGROUND: The generic self-reported Recovering Quality of Life (ReQoL) measures were developed for measuring recovery-focused health-related quality of life (HrQoL) in persons with mental health conditions. The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with affective disorders in Germany. METHODS: Data from a patient sub-sample in a randomized controlled trial have been used (N = 393). The internal consistency and the test-retest reliability of the ReQoL measures were assessed using Cronbach's Alpha and the intra-class correlation coefficient (ICC). The concurrent validity and the known-group validity of the ReQoL measures were assessed using Pearson's Correlation coefficient and Cohen's d. The responsiveness was assessed using Glass' Δ and the standardized response mean (SRM). RESULTS: The reliability among the items of the ReQoL-20 was overall excellent. The ICC of the ReQoL-20 was r = 0.70, indicating moderate test-retest reliability. The concurrent validity of the ReQoL-20 with the clinical measure PHQ-9 was strong with a correlation coefficient of r = - 0.76. The known-group validity of the ReQoL-20 using PHQ-9 cut-off points was large with an effect size of d = 1.63. The ReQoL measures were sensitive to treatment response and remission of symptoms measured by the PHQ-9 with large effect sizes/SRM. DISCUSSION: The psychometric properties of the ReQoL measures for the assessment of patients with affective disorders were overall good. With the ReQoL, valid and reliable measures for the assessment of recovery-focused HrQoL for persons with affective disorders are available in German language.

Long-term psychodynamic psychotherapy in a face-to-face versus videoconferencing setting: A single case study.

OBJECTIVE: Due to the coronavirus pandemic and crisis, psychotherapists around the world were forced to switch to video- or tele-based treatments overnight. To date, only a few studies on the effectiveness of video-based psychodynamic psychotherapy via the Internet exist. Therefore, the goal of the present study was to examine symptom improvement, therapeutic relationship, nonverbal synchrony processes, and intersession processes within a systematic single case design and compare face-to-face to video-based approaches in long-term psychodynamic-oriented psychotherapy. METHODS: We examined 85 sessions of a client with major depression whose psychodynamic psychotherapy changed from a face-to-face setting to a video-based setting. Video recordings were analyzed using motion energy analysis, and nonverbal synchrony was computed using a surrogate synchrony approach. Time series analyses were performed to analyze changes in symptom severity, therapeutic relationship, and intersession processes. RESULTS: The results showed that symptom severity improved descriptively, but not significantly, across the entire course of psychotherapy. There were significant differences, however, in the therapeutic relationship, intersession experiences, and synchronous behavior between the face-to-face and video-based settings. CONCLUSION: The results indicate that the presented methodology is well situated to investigate the question whether psychodynamic psychotherapy in video-based setting works in the sameway as in a face-to-face setting.

Excess costs of mental disorders by level of severity.

INTRODUCTION: Mental disorders are highly prevalent in Germany, and associated with decreased quality of life for those affected as well as high economic burden for the society. The purpose of this study was to determine the excess costs of mental disorders and to examine how these differ with respect to disease severity. METHODS: We analyzed mean 6-month costs using the baseline data from the RECOVER trial in Hamburg, Germany, which evaluates an innovative stepped-care model for mental disorders. Four severity levels were classified based on the current level of mental illness, loss of functioning, and psychiatric diagnosis. In this work, direct costs (outpatient, inpatient, and social/informal care) and indirect costs (sick leave, unemployment, and early retirement) were estimated using interview-based data on health care utilization and productivity losses. Excess costs were determined by matching a comparison group of the German general population without mental disorders. Group differences in sociodemographic covariates and somatic comorbidities were balanced using entropy balancing. Excess costs by severity levels were estimated using generalized linear models (GLM) with gamma distribution and log-link function. RESULTS: Overall, the RECOVER group included n = 816 and the comparison group included n = 3226 individuals. Mean total 6-month excess costs amounted to 19,075€, with higher indirect excess costs (13,331€) than direct excess costs (5744€) in total excess costs. The excess costs increased with increasing disease severity, ranging from 6,123€ with mild disease severity (level 1) to 31,883€ with severe mental illness (level 4). Indirect excess costs ranged from 5612€ in level 1 to 21,399€ in level 4, and were statistically significant for all disease severity levels. In contrast, direct excess costs were only statistically significant for the levels 2 to 4, and ranged from 511€ in level 1 to 10,485€ in level 4. The main cost drivers were hospital stays (level 2-4), sick leave and unemployment (all levels), and early retirement (level 3-4). DISCUSSION: Mental disorders are associated with high costs that increase with the level of disease severity, which was also shown for individual ICD-10 diagnosis groups. Due to their influence on costs, indirect costs and disease severity levels should be considered in future cost-of-illness studies of mental disorders. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, trial registration number NCT03459664.

Health-related quality of life in family caregivers of autistic adults.

Introduction: Family members of autistic individuals often provide support for their autistic relative throughout the lifespan which can lead to massive burden themselves. Reduced health-related Quality of Life (HRQoL) in family caregivers is assumed; however, only a handful studies on the HRQoL of family caregivers providing care to adult relatives exist as opposed to autistic children. Thus, the current study aimed to (i) investigate the current state of physical and mental HRQoL of family caregivers of autistic adults compared to the general population, and (ii) examine caregiver-related (e.g., age, subjective caregiver burden) and care recipient-related variables (e.g., symptom severity, utilization of formal services) explaining variance in the caregivers' HRQoL. Methods: N = 149 family caregivers completed a nationwide online survey, including the Short-Form Health Survey (SF-8) in order to assess the HRQoL. T-tests were used to compare the HRQoL of family caregivers with the general population. Bivariate correlational and multiple linear regression analyses were conducted in order to identify predictors explaining variance in family caregivers' HRQoL. Results: Family caregivers of autistic adults reported significantly lower physical (M = 46.71, SD = 8.72, Cohen's d = 0.42) and mental HRQoL (M = 40.15, SD = 11.28, Cohen's d = 1.35) compared to the general population. Multiple linear regression with the mental HRQoL as the outcome showed a significant model (F(11, 95) = 5.53, p < .001, adj. R2 = .32) with increased subjective burden explaining most of the variance in mental HRQoL (ß = .32, GDW = .141, p < .001). Multiple linear regression analysis with the outcome physical HRQoL did not reveal a statistically significant model (F(11,95) = 1.09, p = .38). However, bivariate analyses also showed a positive correlation with the subjective caregiver burden (r= .20, p < .05). Discussion: Findings highlight the need to consider HRQoL (and caregiver burden) of family caregivers of autistic adults in several healthcare settings to monitor a potential comprised health status in early stages, with the long-term goal to improve family caregivers' HRQoL.

[Mentalization ability and treatment success in psychosomatic rehabilitation]. / Mentalisierungsfähigkeit und Behandlungserfolg in der Psychosomatischen Rehabilitation.

Objectives: Psychosomatic rehabilitation clinics represent an important branch of care with good treatment results in Germany. So far, however, it is largely unclear which processes underlie the treatment successes. In the partial evaluations of the Hersfeld catamnesis study presented here, recourse is made to the construct of mentalizing ability, which has become very important in recent psychotherapy research. Methods: The mentalization ability of a large sample (N = 559) was assessed with the help of the Mentalization Questionnaire (MZQ), and psychological and somatic complaints were assessed with HEALTH-PSB scale from HEALTH-49 at three points in time, namely at admission, at discharge and in a 6-month catamnesis. Results: Both the total score of the MZQ and all subscores show significant reductions in mentalization deficits in the small effect size range, the HEALTH-PSB in the high effect size range and the catamnesis in the medium effect size range. A regression analysis shows that the reduction in mentalization deficits has a high predictive power for symptom improvement. Conclusions: The results indicate that the construct of mentalization ability is a central target variable in psychosomatic rehabilitation.