Background Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet’s increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI). Objective The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women’s hospitals of Heidelberg and Tübingen, Germany. Methods Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness. Discussion This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome. Trial registration Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210. Registered on 13 January 2020. Retrospectively registered.

Background Depressive disorders are associated with a high burden of disease. However, due to the burden posed by the disease on not only the sufferers, but also on their relatives, there is an ongoing debate about which costs to include and, hence, which perspective should be applied. Therefore, the aim of this paper was to examine whether the change between healthcare payer and societal perspective leads to different conclusions of cost-utility analyses in the case of depression. Methods A systematic literature search was conducted to identify economic evaluations of interventions in depression, launched on Medline and the Cost-Effectiveness Registry of the Tufts University using a ten-year time horizon (2008–2018). In a two-stepped screening process, cost-utility studies were selected by means of specified inclusion and exclusion criteria. Subsequently, relevant findings was extracted and, if not fully stated, calculated by the authors of this work. Results Overall, 53 articles with 92 complete economic evaluations, reporting costs from healthcare payer/provider and societal perspective, were identified. More precisely, 22 estimations (24%) changed their results regarding the cost-effectiveness quadrant when the societal perspective was included. Furthermore, 5% of the ICURs resulted in cost-effectiveness regarding the chosen threshold (2% of them became dominant) when societal costs were included. However, another four estimations (4%) showed the opposite result: these interventions were no longer cost-effective after the inclusion of societal costs. Conclusions Summarising the disparities in results and applied methods, the results show that societal costs might alter the conclusions in cost-utility analyses. Hence, the relevance of the perspectives chosen should be taken into account when carrying out an economic evaluation. This systematic review demonstrates that the results of economic evaluations can be affected by different methods available for estimating non-healthcare costs.

Background Due to demographic changes, the elderly population in western countries is constantly growing. As the risk of functional decline and multimorbidity increases with age, health care systems need to face the challenge of high demand for health care services and related costs. Therefore, innovative health care approaches and geriatric screenings are needed to provide individualised care. This study aims to expand the state of research by investigating the effectiveness of a multi-component care approach for the elderly in a German community setting. Methods A prospective, quasi-experimental study was initiated by statutory health insurance (SHI) companies. The innovative care approach includes a geriatric assessment, a case and network management as well as digital supporting tools and was implemented at the Center for Geriatrics and Gerontology (Albertinen Haus, Hamburg-Eimsbuettel). Participants of the intervention were compared to matched controls recruited in comparable urban areas. The primary outcome measure was the progression in long-term care grade during the period of observation (21 months), which was analysed on the basis of SHI claims data. Secondary endpoints were morbidity, mortality and self-reported health-related quality of life (HRQoL) measured by SF-36. Results Overall, 2,670 patients (intervention group (IG) n=873; control group (CG) n=1,797) were analysed. Logistic regression analysis showed no statistically significant difference in progression of long-term care grade between IG and CG (Odds Ratio (OR)=1.054; 95% confidence interval (CI) 0.856-1.296; p-value=0.616). Differentiated analyses indicated an initial effect, which might be attributable to the geriatric assessment. However, an adapted regression model resulted in a reversed but even non-significant effect (OR=0.945; 95% CI 0.757-1.177; p-value=0.619). While secondary analyses of long-term care grade, mortality and HRQoL did not show intervention effects, a statistically significant relative change of 0.865 (95% CI 0.780, 0.960; p-value=0.006) in morbidity indicated a potential benefit for the IG. Conclusions The analyses did not reveal a significant effect of the community-based intervention on the primary outcome and thus we are not able to recommend a transfer into SHI standard care. Tendencies in secondary analyses need to be proved in further research. Trial registration German Clinical Trials Register, retrospective registration on February 01, 2022 (DRKS00027866).

Zusammenfassung Hintergrund An den Einsatz gesundheitsbezogener digitaler Anwendungen auf mobilen Endgeräten („Gesundheits-Apps“) sind große Nutzenerwartungen geknüpft. Die regelhafte Bereitstellung dieser mobilen Gesundheitstechnologien über die Gesetzliche Krankenversicherung (GKV) erfolgt bislang jedoch nicht. Dies lässt die Existenz struktureller Probleme im Zugang zur GKV-Erstattung vermuten. Ziel Ziel dieser Studie ist die Identifikation von Herausforderungen, welche den erfolgreichen GKV-Zugang mobiler Gesundheitstechnologien erschweren. Material und Methoden Zwischen acht und zwölf Vertreter zentraler am Zugangsprozess beteiligter Akteursgruppen diskutierten in fünf teilstrukturierten Fokusgruppeninterviews die Herausforderungen entlang potenzieller GKV-Zugangswege. Die Auswertung erfolgte mittels zusammenfassender Inhaltsanalyse nach Mayring. Ergebnisse Es wurden zugangswegübergreifende und -spezifische Herausforderungen identifiziert. Übergreifend nahmen die Interviewten Wissens- und Informationsdefizite bezüglich der Zugangsanforderungen sowie die fehlende Vereinbarkeit mobiler Gesundheitstechnologien mit den segmentierten Regelungsbereichen des SGB V als Problemfelder wahr. Die Bereiche Primärprävention und Selektivverträge wurden als bereits gut geebnete Wege in die Erstattung erachtet. Für die Bereiche Neue Untersuchungs- und Behandlungsmethoden, Heil- und Hilfsmittelversorgung wurden größere Herausforderungen identifiziert, die neben unklarer Zugangseignung verschiedene prozessuale Hürden umfassen. Schlussfolgerung Die bessere Nutzung der Potenziale mobiler Gesundheitstechnologien erfordert die Adressierung der beschriebenen Herausforderungen durch gesetzliche und untergesetzliche Maßnahmen. Angesichts der heterogenen Positionen sollte die Entwicklung dieser Lösungsansätze unter enger Einbindung der Stakeholder erfolgen.

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