[Patient safety in the Innovation Fund - Characterization, results and evaluation of completed projects: Results of a scoping review]. / Patientensicherheit im Innovationsfonds ­ Charakterisierung, Resultate und Bewertung abgeschlossener Projekte: Ergebnisse eines Scoping Reviews.

The German Innovation Fund has funded various studies on patient safety. Their thematic spectrum, methodological quality, results and recommendations of the Innovation committee were to be systematically investigated in order to derive proposals for optimizing transfer success. As part of a scoping review, all Innovation Fund projects funded in the period 2016-02/2023 with a focus on patient safety were analyzed. Each included study document was critically reviewed by two independent persons. The 16 included projects addressed a wide range of populations, indications and interventions. The study quality was mostly good. The results ranged from feasible indicator sets and the prevention of adverse drug reactions to the optimization of error management. For seven projects, the Innovation Committee recommended forwarding the results to healthcare institutions with the request that they take note and/or examine the feasibility of implementation in standard care. Implementation, however, has not yet taken place. In order to facilitate implementation, the joint development of an implementation strategy by the recipients of the Innovation Committee's recommendations is necessary.

Childhood Trauma Questionnaire-based child maltreatment profiles to predict efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus non-specific psychotherapy in adults with early-onset chronic depression: cluster analysis of data from a randomised controlled trial.

BACKGROUND: Child maltreatment is a broadly confirmed risk factor for mental and physical illness. Some psychological treatments specifically target mental health conditions associated with child maltreatment. For example, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) focuses on maladaptive interpersonal behaviours in chronic depression. However, how the assessment of child maltreatment could inform personalised treatment is unclear. We used data from a previously published clinical trial to investigate whether a pre-established child maltreatment clustering approach predicts differential outcomes after CBASP versus non-specific supportive psychotherapy in patients with early-onset chronic depression. METHODS: We did a cluster analysis of data from a previous randomised controlled trial of unmedicated adult outpatients with early-onset chronic depression who were treated at eight university clinics and psychological institutes in Germany with 32 sessions of CBASP or non-specific supportive psychotherapy. Participants were eligible for the original trial if they were aged 18-65 years; had major depressive disorder (MDD) with an early onset and duration of at least 2 years, current MDD superimposed on a pre-existing dysthymic disorder, or recurrent MDD with incomplete remission between episodes as defined by DSM-IV; and had a score of at least 20 points on the 24-item Hamilton Rating Scale for Depression (HRSD-24). Participants were included in the current study if they had completed the short form of the Childhood Trauma Questionnaire (CTQ) at trial baseline. We used an agglomerative hierarchical clustering approach to derive child maltreatment clusters from individual patterns across the five domains of the CTQ. We used linear mixed models to investigate whether clustering could predict differential clinical outcomes (change in symptom severity on the HRSD-24) up to 2 years after treatment onset. People with lived experience were involved in the current study. FINDINGS: 253 patients (129 [51%] treated with CBASP and 124 [49%] with supportive psychotherapy) had complete CTQ records and were included in the analysis. 169 (67%) participants were women, 84 (33%) were men, and the mean age was 45·9 years (SD 11·7). We identified seven child maltreatment clusters and found significant differences in treatment effects of CBASP and supportive psychotherapy between the clusters (F(6,948·76)=2·47; p=0·023); differences were maintained over the 2-year follow-up. CBASP was superior in distinct clusters of co-occurring child maltreatment: predominant emotional neglect (change in ß -6·02 [95% CI -11·9 to -0·13]; Cohen's d=-0·98 [95% CI -1·94 to -0·02]; p=0·045), predominant emotional neglect and abuse (-6·39 [-10·22 to -2·56]; -1·04 [-1·67 to -0·42]; p=0·0011), and emotional neglect and emotional and physical abuse (-9·41 [-15·91 to -2·91]; -1·54 [-2·6 to -0·47]; p=0·0046). INTERPRETATION: CTQ-based cluster analysis can facilitate identification of patients with early-onset chronic depression who would specifically benefit from CBASP. Child maltreatment clusters could be implemented in clinical assessments and serve to develop and personalise trauma-informed care in mental health. FUNDING: The German Research Foundation and the German Federal Ministry of Education and Research.

Effects of a skin type diversity seminar on undergraduate medical students' self-assessed competence in managing skin diseases in patients with skin of color.

BACKGROUND: Skin diseases in patients with skin of colour (Fitzpatrick skin types IV to VI) are underrepresented in dermatology training, which may lead to lower quality of care for these patients. To address this underrepresentation in medical education, a newly developed seminar on skin type diversity using an interactive teaching method was implemented in an undergraduate medical curriculum. This study examined the effects of a seminar on the self-assessed competence of medical students in managing skin conditions in patients with skin of colour. METHODS: A questionnaire survey was conducted among fourth-year undergraduate medical students at the University of Hamburg (Germany) between October 2023 and February 2024. Students' self-assessed competence was compared before and after the obligatory seminar (pre- and post-design). RESULTS: In total, 158 students participated in the survey. After the seminar, knowledge of the presentation of skin diseases in patients with skin of colour and the associated psychological burden, differences in the incidence of skin diseases in different skin types, and the ability to diagnose skin diseases in darker skin types increased. Most participants stated that they wanted to attend more courses on this topic. DISCUSSION: Appropriate courses for medical students can improve their competence in managing different skin diseases in patients with skin of colour. In the future, more attention should be paid to teaching the diversity of skin types in dermatology education.

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.

Patient experiences of interprofessional collaboration and intersectoral communication in rare disease healthcare in Germany - a mixed-methods study.

BACKGROUND: Rare diseases are often complex, chronic and many of them life-shortening. In Germany, healthcare for rare diseases is organized in expert centers for rare diseases. Most patients additionally have regional general practicioners and specialists for basic medical care. Thus, collaboration and information exchange between sectors is highly relevant. Our study focuses on the patient and caregiver perspective on intersectoral and interdisciplinary care between local healthcare professionals (HCPs) and centers for rare diseases in Germany. The aims were (1) to investigate patients' and caregivers' general experience of healthcare, (2) to analyse patients' and caregivers' perception of collaboration and cooperation between local healthcare professionals and expert centers for rare diseases and (3) to investigate patients' and caregivers' satisfaction with healthcare in the expert centers for rare diseases. RESULTS: In total 299 individuals of whom 176 were patients and 123 were caregivers to pediatric patients participated in a survey using a questionnaire comprising several instruments and constructs. Fifty participants were additionally interviewed using a semistructured guideline. Most patients reported to receive written information about their care, have a contact person for medical issues and experienced interdisciplinary exchange within the centers for rare diseases. Patients and caregivers in our sample were mainly satisfied with the healthcare in the centers for rare diseases. The qualitative interviews showed a rather mixed picture including experiences of uncoordinated care, low engagement and communication difficulties between professionals of different sectors. Patients reported several factors that influenced the organization and quality of healthcare e.g. engagement and health literacy in patients or engagement of HCPs. CONCLUSIONS: Our findings indicate the high relevance of transferring affected patients to specialized care as fast as possible to provide best medical treatment and increase patient satisfaction. Intersectoral collaboration should exceed written information exchange and should unburden patients of being and feeling responsible for communication between sectors and specialists. Results indicate a lack of inclusion of psychosocial aspects in routine care, which suggests opportunities for necessary improvements.

Public Beliefs About Accessibility and Quality of Emergency Departments in Germany.

Background: It is well established that emergency department (ED) crowding leads to worse health outcomes. Although various patient surveys provide information about reasons to visit EDs, less is known in terms of beliefs about EDs among the general population. This study examines public beliefs regarding accessibility and quality of EDs and their associations with social characteristics (gender, age, education, immigration background) as well as knowledge about emergency care services and health literacy. Methods: We conducted a cross-sectional study based on a random sample of 2,404 adults living in Hamburg, Germany, in winter 2021/2022. We developed eight statements regarding accessibility and quality of EDs leading to two scales (Cronbach's α accessibility = 0.76 and quality of care = 0.75). Descriptive statistics of the eight items are shown and linear regression were conducted to determine associations of the two scales with social characteristics as well as knowledge about emergency care services and health literacy (HLS-EU-Q6). Results: Nearly 44% of the respondents agreed that "you can always go to an ED, if you do not get a short-term appointment with a general practitioner or specialist." And 38% agreed with the statement, "If you do not have the time during normal practice hours due to your work, you can always go to an ED." In terms of quality, 38% believed that doctors in EDs are more competent than doctors in general practice, and 25% believed that doctors in EDs are more competent than doctors in specialized practices. In the fully adjusted model, public beliefs about emergency care accessibility and quality of EDs were significantly associated with all social characteristics and knowledge of emergency care options with the strongest associations between knowledge and accessibility (ß = -0.17; P < 0.001) and between education and quality (ß = -0.23; P < 0.001). Conclusion: We found endorsement of public beliefs about accessibility and quality of EDs that can lead to inappropriate utilization. Our results also suggest that knowledge of different emergency services plays an important role. Therefore, after system-related reorganizations of emergency care, information campaigns about such services tailored to socially deprived populations may help alleviate the issue of crowding.

Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis.

OBJECTIVE: We evaluated differential treatment effects on specific symptoms and their mediators for Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Supportive Psychotherapy (SP) in persistently depressed patients. METHOD: We conducted a Bayesian mediation network intervention analysis with data from a randomized controlled trial comparing CBASP and SP. Three networks were calculated to investigate (1) differential treatment effects on specific symptoms, (2) differential treatment effects on the potential mediators interpersonal problems and social functioning, and (3) associations between change in symptoms and change in the potential mediators. RESULTS: First, we found no evidence that CBASP more strongly improves most depressive symptoms specifically, except minimal evidence of symptom-specific effects on sleeping problems and self-esteem. Second, no and minimal evidence for differential treatment effects on interpersonal problems and social functioning was shown, respectively. Third, interpersonal problems and social functioning were strongly related to depressive symptoms. CONCLUSION: While CBASP showed superior treatment effects for overall symptom severity, this treatment might not be superior in improving specific symptoms and the potential mediators interpersonal problems and social functioning. Still, interpersonal problems and social functioning seem to play an important role for depression symptoms. Future research needs to further investigate potential working mechanisms of CBASP.Trial registration: ClinicalTrials.gov identifier: NCT00970437.

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.

[Intended utilization of health care services in cases of mental illnesses with varying urgency]. / Intendierte Inanspruchnahme von Versorgungsangeboten bei psychischen Erkrankungen mit unterschiedlicher Dringlichkeit.

OBJECTIVE: To investigate variations in intended utilization in cases of an acute psychotic episode, an alcohol related or depressive disorder depending on different case characteristics. METHODS: A telephone survey with case vignettes was conducted (N=1,200). Vignettes varied in terms of urgency of symptoms, daytime, sex of the afflicted person and age/mental disorder. The respondents were asked to indicate whom they would contact first in the described case. RESULTS: Outpatient physicians were named most frequently as the first point of contact (61.1%) while only 6.5% of the respondents named emergency medicine including the medical on call service (8.1% in high urgency cases, i. e. emergencies that did not tolerate any delay). Intended utilization varied by urgency and age/mental illness. CONCLUSION: More Information about the need to seek medical help immediately in cases of mental illnesses with high urgency should be provided.

[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

A flexible approach to measure care coordination based on patient-sharing networks.

BACKGROUND: Effective care coordination may increase clinical efficiency, but its measurement remains difficult. The established metric "care density" (CD) measures care coordination based on patient-sharing among physicians, but it may be too rigid to generalize across disorders and countries. Therefore, we propose an extension called fragmented care density (FCD), which allows varying weights for connections between different types of providers. We compare both metrics in their ability to predict hospitalizations due to schizophrenia. METHODS: We conducted a longitudinal cohort study based on German claims data from 2014 through 2017 to predict quarterly hospital admissions. 21,016 patients with schizophrenia from the federal state Baden-Württemberg were included. CD and FCD were calculated based on patient-sharing networks. The weights of FCD were optimized to predict hospital admissions during the first year of a 24-month follow-up. Subsequently, we employed likelihood ratio tests to assess whether adding either CD or FCD improved a baseline model with control variables for the second follow-up year. RESULTS: The inclusion of FCD significantly improved the baseline model, Χ2(1) = 53.30, p < 0.001. We found that patients with lower percentiles in FCD had an up to 21% lower hospitalization risk than those with median or higher values, whereas CD did not affect the risk. CONCLUSIONS: FCD is an adaptive metric that can weight provider relationships based on their relevance for predicting any outcome. We used it to better understand which medical specialties need to be involved to reduce hospitalization risk for patients with schizophrenia. As FCD can be modified for different health conditions and systems, it is broadly applicable and might help to identify barriers and promoting factors for effective collaboration.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Implementation of Hospital Mortality Reviews: A Systematic Review.

OBJECTIVE: The objective of this study was to give an overview of the published literature on the implementation of mortality reviews in hospital settings. METHODS: We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, and Web of Science databases up to August 2022 for studies describing implementation or results of implementation of hospital mortality reviews published in English or German. Quality appraisal was conducted using the Mixed Methods Appraisal Tool. Two independent reviewers screened the title/abstract and the full text of potentially relevant records and extracted data using a standardized form. We synthesized and integrated quantitative and qualitative findings narratively following a convergent segregated mixed methods review approach. RESULTS: From the 884 studies screened, 18 publications met all inclusion criteria and were included in the review. Observed mortality rates reported in 10 publications ranged from 0.4% to 7.8%. In 10 publications, mortality reviews were implemented as a multistep process. In 7 publications, structured mortality review meetings were implemented. Key aspects of success in developing and implementing mortality reviews in hospitals were involvement of multiple stakeholders, providing enough resources for included staff, and constant monitoring and adaption of the processes. CONCLUSIONS: Although awareness of hospital mortality reviews has increased over the last decades, published research in this area is still rare. Our results may inform hospitals considering development and implementation of mortality reviews by providing key aspects and lessons learned from existing implementation experiences.

Variations in the intended utilization of emergency care in case of gastrointestinal diseases.

Frequent utilization of emergency care and overcrowded emergency departments (EDs) are highly relevant topics due to their harmful consequences for patients and staff. The present study examines variations of intended health care use in urgent and non-urgent cases among the general population. In a cross-sectional telephone survey, a sample of N = 1,204 adults residing in Hamburg, Germany, was randomly drawn. At the beginning of the survey, one of 24 different vignettes (case stories) describing symptoms of inflammatory gastrointestinal diseases were presented to the participants. The vignettes varied in sex (male/female), age (15, 49, 72 years), daytime (Tuesday morning, Tuesday evening), and urgency (low, high). Participants were asked in an open-ended question about their primal intended utilization if they or their children would be affected by such symptoms. Overall, about 14 % chose emergency facilities (ED, ambulance, emergency practice) despite presentation of non-urgent conditions (n = 602). Intended emergency care use varied considerably even if the degree of urgency was comparable. Adolescence, male sex, and symptoms occurring in the evening were associated with increased ED and ambulance use. Inappropriate utilization of ED and ambulance (analyses regarding utilization due to non-urgent problems) was more often observed among male respondents and those with a migration background (1st generation). Information campaigns focused on emergency care use and reorganisation of emergency care wards are possible interventions.

Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease.

BACKGROUND: Supervised exercise programs are used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such exercise program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic multicenter randomized controlled trial (registration number NCT03496948), 1982 patients with symp - tomatic IC insured by one of three German statutory health insurance funds received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores after 12 and 24 months in the intention-to-treat population. The secondary outcomes were healthrelated quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine depen - dence. RESULTS: There was a significant group difference in WIQ score in favor of TeGeCoach (p < 0.0001), amounting to 6.30 points at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points at 24 months ([2.20; 6.91], d = 0.19). Some of the secondary outcomes also showed positive results in favor of TeGeCoach at 12 months with small effect sizes (d ≥ 0.20), including physical health-related quality of life and patient activation. The average daily step count was not higher in the TeGeCoach group. CONCLUSION: Significant improvements regarding symptom burden demonstrate the benefit of a home-based exercise program and thus expand the opportunities for guideline-oriented treatment of IC. Future studies should additionally address the effect of home-based exercise programs on clinical variables by means of, for example, the 6-minute walk test.

Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.

INTRODUCTION: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. METHODS: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. RESULTS: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3-4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R2 N = 0.64). CONCLUSION: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.

Perceived treatment urgency of common mental disorders in the German population.

Perceived treatment urgency of mental disorders are important as they determine utilization of health care. The aim was to analyze variations in perceived treatment urgency in cases of psychosis (adolescents), alcoholism (adults), and depression (older adults) with two levels of severity each by characteristics of the case and the respondents. A telephone survey (N = 1200) with vignettes describing cases of psychosis, alcoholism, and depression was conducted in Hamburg, Germany. Vignettes varied by symptom severity and sex. Perceived treatment urgency was assessed by three items. A sum scale was calculated. Linear regression models were computed to analyze differences in perceived urgency by characteristics of the case (severity, sex) and the respondents (sex, age, education, migration background, illness recognition, personal affliction). Perceived treatment urgency was significantly higher in severe cases and varied by education. Additionally, regarding psychosis, estimated urgency varied significantly by correct illness recognition. With regard to depression, perceived urgency differed significantly by age and correct illness recognition. Interaction effects between case severity and sociodemographic characteristics of the respondents, personal affliction, and correct recognition of the disorder were found. The identified differences should be considered in the development of interventions on mental health literacy with regard to adequate urgency assessment.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

Background: The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). Materials and methods: AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Results: Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. Conclusion: We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. Clinical trial registration: DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).