Assessing ChatGPT's Mastery of Bloom's Taxonomy Using Psychosomatic Medicine Exam Questions: Mixed-Methods Study.

BACKGROUND: Large language models such as GPT-4 (Generative Pre-trained Transformer 4) are being increasingly used in medicine and medical education. However, these models are prone to "hallucinations" (ie, outputs that seem convincing while being factually incorrect). It is currently unknown how these errors by large language models relate to the different cognitive levels defined in Bloom's taxonomy. OBJECTIVE: This study aims to explore how GPT-4 performs in terms of Bloom's taxonomy using psychosomatic medicine exam questions. METHODS: We used a large data set of psychosomatic medicine multiple-choice questions (N=307) with real-world results derived from medical school exams. GPT-4 answered the multiple-choice questions using 2 distinct prompt versions: detailed and short. The answers were analyzed using a quantitative approach and a qualitative approach. Focusing on incorrectly answered questions, we categorized reasoning errors according to the hierarchical framework of Bloom's taxonomy. RESULTS: GPT-4's performance in answering exam questions yielded a high success rate: 93% (284/307) for the detailed prompt and 91% (278/307) for the short prompt. Questions answered correctly by GPT-4 had a statistically significant higher difficulty than questions answered incorrectly (P=.002 for the detailed prompt and P<.001 for the short prompt). Independent of the prompt, GPT-4's lowest exam performance was 78.9% (15/19), thereby always surpassing the "pass" threshold. Our qualitative analysis of incorrect answers, based on Bloom's taxonomy, showed that errors were primarily in the "remember" (29/68) and "understand" (23/68) cognitive levels; specific issues arose in recalling details, understanding conceptual relationships, and adhering to standardized guidelines. CONCLUSIONS: GPT-4 demonstrated a remarkable success rate when confronted with psychosomatic medicine multiple-choice exam questions, aligning with previous findings. When evaluated through Bloom's taxonomy, our data revealed that GPT-4 occasionally ignored specific facts (remember), provided illogical reasoning (understand), or failed to apply concepts to a new situation (apply). These errors, which were confidently presented, could be attributed to inherent model biases and the tendency to generate outputs that maximize likelihood.

Renal failure following insulin purging in atypical anorexia nervosa and type 1 diabetes mellitus.

Objective: Anorexia nervosa (AN) and atypical anorexia nervosa (AAN) are severe and complex eating disorders that can be prevalent among individuals with type 1 diabetes mellitus (T1DM). Insulin purging, characterized by the intentional underuse / omission of insulin to control weight, is under-recognized in medicine and is a purging strategy of patients with AN or AAN and comorbid T1DM. Often, this can lead to renal failure, necessitating a (pancreas-) kidney transplantation. This article presents a comprehensive overview of the interplay between AN/AAN and T1DM and summarizes the evidence in literature. Methods: A narrative review is presented on basis of a detailed case study of a 32-year-old female with end-stage renal failure seeking (pancreas-) kidney transplantation displaying etiology, diagnosis, comorbidities, complications, and treatment of AN and AAN with emphasis on those patients with T1DM. Results: Insulin purging in patients with AN/AAN and coexisting T1DM can exacerbate T1DM complications, including accelerating the onset of end-stage renal failure. A multidisciplinary approach including nutrition treatment and psychotherapeutic techniques was considered necessary for treatment, focusing on psychosomatic in-patient care before and after organ transplantation. Conclusion: Insulin purging in patients with AAN and T1DM poses severe health risks, including accelerated renal complications. For those considering transplantation, insulin purging has explicitly to be diagnosed and a holistic treatment addressing both the renal condition and psychosomatic symptoms/disorders is crucial for successful post-transplant outcomes.

Using an Electronic Mindfulness-based Intervention (eMBI) to improve maternal mental health during pregnancy: Results from a randomized controlled trial.

Prevalence rates of peripartum depression and anxiety are high and correlate with adverse maternal and neonatal outcomes. Mindfulness-based interventions (MBI) have been shown to reduce mental distress during pregnancy. A multicenter, randomized controlled study was conducted after screening for depressive symptoms. The intervention group (IG) was given access to an 8-week supervised eMBI between weeks 29 and 36 of pregnancy and followed up to 5 months postpartum. Psychometric data were collected using the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory (STAI), the Pregnancy-Related Anxiety Questionnaire (PRAQ-R), the Freiburg Mindfulness Inventory (FMI-14) as well as the Patient Health Questionnaire (PHQ). Out of 5299 pregnant women, 1153 scored >9 on the EPDS and N = 460 were included in the RCT. No significant interaction effects for depressive symptoms and anxiety were found. Pregnancy- and birth-related anxiety decreased significantly in the IG and 6 weeks after birth, the rate of women at risk for adverse mental outcome was significantly lower compared to the CG. Mindfulness scores improved significantly in the IG. The eMBI program did not show effective regarding general depressive or anxiety symptoms, however, positive results were demonstrated regarding pregnancy and birth-related anxiety and the prevention of postpartum depression.

The multicenter effectiveness study of inpatient and day hospital treatment in departments of psychosomatic medicine and psychotherapy in Germany.

Background: Reliable outcome data of psychosomatic inpatient and day hospital treatment with a focus on psychotherapy are important to strengthen ecological validity by assessing the reality of mental health care in the field. This study aims to evaluate the effectiveness of inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy in a prospective, naturalistic, multicenter design including structured assessments. Methods: Structured interviews were used to diagnose mental disorders according to ICD-10 and DSM-IV at baseline. Depression, anxiety, somatization, eating disorder and posttraumatic stress disorder (PTSD) symptoms, as well as personality functioning were assessed by means of questionnaires on admission and at discharge. Results: 2,094 patients recruited by 19 participating university hospitals consented to participation in the study. Effect sizes for each of the outcome criteria were calculated for 4-5 sub-groups per outcome domain with differing severity at baseline. Pre-post effect sizes for patients with moderate and high symptom severity at baseline ranged from d = 0.78 to d = 3.61 with symptoms of PTSD, depression, and anxiety showing the largest and somatization as well as personality functioning showing somewhat smaller effects. Conclusions: Inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy is effective under field conditions. Clinical trial registration: https://drks.de/search/de/trial/DRKS00016412, identifier: DRKS00016412.

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.

The role of face masks within in-patient psychotherapy: Results of a survey among inpatients and healthcare professionals.

Introduction: Face-to-face medical and psychotherapeutic treatments during the Corona pandemic often involve patients and health care providers wearing face masks. We performed a pilot survey assessing the subjective experience of wearing face masks during psychotherapy sessions regarding (i) feasibility, (ii) psychotherapeutic treatment and (iii) communication, emotion and working alliance in patients and healthcare professionals. Methods: A total of n = 62 inpatients (RR = 95.4%) and n = 33 healthcare professionals (RR = 86.8%) at an academic department of Psychosomatic Medicine and Psychotherapy participated in this survey anonymously. The items of the questionnaire were created by the interprofessional expert team and were based on existing instruments: (i) the Therapeutic Relationship Questionnaire and (ii) the German translation of Yalom's Questionnaire on Experiencing in Group Psychotherapy. Results: The majority of patients rate their psychotherapy as highly profitable despite the mask. In individual therapy, face masks seem to have a rather low impact on subjective experience of psychotherapy and the relationship to the psychotherapist. Most patients reported using alternative facial expressions and expressions. In the interactional group therapy, masks were rather hindering. On the healthcare professional side, there were more frequent negative associations of face masks in relation to (i) experiencing connectedness with colleagues, (ii) forming relationships, and (iii) therapeutic treatment. Discussion: Information should be given to patients about the possible effects of face masks on the recognition of emotions, possible misinterpretations and compensation possibilities through alternative stimuli (e.g., eye area) and they should be encouraged to ask for further information. Especially in group therapy, with patients from other cultural backgrounds and in cases of need for help (e.g., hearing impairment) or complex disorders, appropriate non-verbal gestures and body language should be used to match the intended emotional expression.

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized.

Introduction: Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods: The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results: Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion: Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches.

Where there are challenges, there are opportunities: An undergraduate medical students' teaching concept for mental health in times of COVID-19.

COVID-19 had a tremendous effect on medical education. Most teaching sessions had to be shifted online, posing additional stress and potential isolation on medical students. However, it also offered the promotion of innovative digital teaching concepts. In this article, an approach to undergraduate mental health training is presented and evaluated. The curriculum was designed according to Kern's six-step approach and consisted of asynchronous online material as well synchronous digital teaching and was accompanied by a plethora of newly developed teaching material (videos, fact sheets, etc.). Content covered the whole spectrum of diseases seen in a service of psychosomatic medicine and psychotherapy (i.e. anxiety, depression, trauma, somatoform and eating disorders, as well as motivational interviewing). Feedback from participants was collected, and exam results (written and practical) were compared to pre-COVID-19 times using t-tests for dependent and independent samples. Students were highly satisfied with the teaching (rating of 1.3 ± 0.6, n = 139 students). There was no significant difference from course evaluations before COVID-19 (1.5 ± 0.5, p > .05). The teaching also received an award in the students' competition "best digital teaching concept in summer term 2020". In the written exams, there was no significant difference between before COVID-19 (2.4 ± 0.45) and during COVID-19 times (1.6 ± 0.39; p > .05). In the practical objective structured clinical examination (OSCE), there was also no significant difference between students' judgement of the difficulty of the station (1.9 ± 0.22 vs 1.9 ± 0.31; p > .05) or how well-prepared they felt for the exam (2.0 ± 0.24 vs 2.0 ± 0.31; p > .05). However, there was a significant difference in terms of grades, with the pre-COVID-19 grades being significantly better (2.7 ± 0.37 vs 2.0 ± 0.44; p < .05), which reflects the difficulty of transferring practical skills training to an online setting. Students particularly valued the possibility of self-directed learning combined with personal guidance by departmental experts, reflecting the importance of wellbeing-centred medical education. The pandemic triggered overnight challenges for teaching mental health that may also offer the opportunity to think about worldwide teaching standards with easily accessible material and courses online. This may offer the opportunity to enthral medical students to become mental health specialists themselves.

Acceptance, experiences, and needs of hospitalized pregnant women toward an electronic mindfulness-based intervention: A pilot mixed-methods study.

Background: Anxiety disorders and depression during pregnancy are highly prevalent. Hospitalized pregnant women with high maternal or fetal risk represent a particularly vulnerable population often excluded from research samples. Screening for mental health disorders is not routinely offered for this particular patient group. Electronic mindfulness-based interventions constitute an accessible, convenient, and cost-effective mental health resource but have not yet been evaluated for acceptance in inpatient settings. To date, little is known about the needs and perceptions of this group of women. Objective: The aim of this study was to examine whether a brief electronic mindfulness-based intervention (eMBI) is accepted among hospitalized high-risk pregnant women. We assessed personal motivation and barriers, experiences, usability requirements, and overall acceptance of the eMBI, as well the specific needs and demands of patients with high-risk pregnancies regarding mental health services. Methods: An exploratory pilot study with a mixed-methods study design was carried out among 30 women hospitalized with a high obstetric risk. The study participants were given access to an eMBI with a 1-week mindfulness program on how to deal with stress, anxiety, and depressive symptoms. Semi-structured interviews were conducted with the 30 participants and analyzed using systematic content analysis. In addition, acceptance and usability were assessed via questionnaires. Results: Study findings showed a high level of acceptance of the eMBI. Most of the respondents were satisfied with the usability and considered the eMBI program to be helpful. The greatest barriers to using the eMBI were a general negative attitude toward using apps, preference for personal contact, or no current need for psychotherapy. Participants criticized the lack of awareness of mental health issues during pregnancy and expressed a need for low-threshold treatment offers, especially during hospitalization. Conclusions: There is a strong need for mental health services in pregnancy care, especially for pregnant women with risk profiles. An eMBI offers an acceptable means of providing mental health support for hospitalized women with a severe obstetric risk.

Post-COVID-19 fatigue: A systematic review.

Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2. This systematic review was performed to describe symptoms, etiology, possible risk factors related to post-COVID-19 fatigue and the therapeutic approaches used for the treatment of post-COVID-19 fatigue. For the systematic literature search the databases PubMed, Web of Science, Cochrane Library, and PsycInfo were used. All articles that met the inclusion criteria were analyzed for demographics, clinical data and treatment. Included were studies which focused on an adult population (18-65 years old); elderly patients and patients with chronic somatic diseases which can also cause fatigue were excluded. We identified 2,851, screened 2,193 and finally included 20 studies with moderate to high methodological quality, encompassing 5,629 participants. Potential risk factors for post-COVID-19 fatigue were old age, female sex, severe clinical status in the acute phase of infection, a high number of comorbidities, and a prediagnosis of depression/anxiety. Lastly, a possible autoimmune etiology was suspected. Several treatment approaches have been tested mostly in small and uncontrolled studies so far: a Chinese herbal formulation improved breathlessness and fatigue. Moreover, molecular hydrogen (H2) inhalation had beneficial health effects in terms of improved physical (6-min walking test) and respiratory function in patients with post-COVID-19. Patients also noticed improvement in fatigue after undergoing hyperbaric oxygen therapy (HBOT) and enhanced external counterpulsation (EECP). Lastly. muscle strength and physical function were improved after undergoing an 8-weeks biweekly physical therapy course including aerobic training, strengthening exercises, diaphragmatic breathing techniques, and mindfulness training. However, larger and controlled studies e.g., investigating the effect of physical and / or psychotherapy for patients with post-COVID-19 fatigue are urgently warranted. Systematic Review Registration: Unique Identifier: CRD42022320676, https://www.crd.york.ac.uk/PROSPERO/.

Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

Mental disorders are no predictors to determine the duration of cannabis-based treatment for chronic pain.

Background: Chronic pain (CP), a complex biopsychosocial disorder with a global prevalence of up to 33%, can be treated by following multidisciplinary approaches that may include cannabis-based medicine (CBM). However, because CBM continues to be a new treatment, questions remain regarding the ideal duration for CBM and its psychosocial determinants, including mental comorbidities. Methods: In a retrospective cross-sectional study involving 46 patients with CP (ICD-10 code F45.4-), three validated instruments-the German Pain Questionnaire, the Depression Anxiety Stress Scale (DASS), and the Marburg Questionnaire of Habitual WellBeing-were used to identify pain-specific psychosocial determinants and mental disorders. Descriptive analyses, a group differences analysis, and a logistic regression analysis were performed using SPSS. Results: The patients most frequently reported low back pain as the primary location of their CP, and in attributing the condition to tissue damage, most had largely adopted a somatic orientation in conceptualizing their illness. Most had experienced CP for more than 5 years (M = 5.13 years, SD = 1.41) and, as a consequence, faced significant restrictions in their everyday life and exhibited low subjective wellbeing (MFHW median = 4.00, N = 43, Q1: 2.00, Q3: 9.00, range: 0-20). Comorbidities among the patients included depression, (DASS-Depression, median: 11.50, Q1: 7.00, Q3: 16.25), anxiety (DASS-Anxiety, median: 4.50, Q1: 2.75, Q3: 8.00), and stress (DASS-Stress, median: 11.00, Q1: 7.00, Q3: 15.00). Between the two cannabis-based treatments with a course lasting either less or more than a year, the duration of treatment showed no between-group differences in terms of sociodemographic factors, pain-specific factors, conceptualizations of the illness, or mental disorders. Psychosocial determinants such as subjective wellbeing and mental comorbidities were not significant predictors of the duration of cannabis-based treatment. Conclusion: We found no evidence indicating that the benefits of short-term vs. long-term cannabis-based treatment can be predicted by mental comorbidities or psychosocial factors. However, because CBM may be included in approaches to treat CP, questions about the ideal duration of such treatment remain to be answered.

Higher Acceptance of Videotelephonic Counseling Formats in Psychosomatic Medicine in Times of the COVID-19 Pandemic.

Background: Due to the COVID-19 pandemic, the healthcare system in general and psychosomatics in particular were forced to change counseling-specific services and break up established structures. At the beginning of 2020, phone as well as videotelephonic counseling options had to be quickly established. Methods: Patients (n = 278) of the department of psychosomatic medicine and psychotherapy at the University Hospital Tübingen were asked to complete an ad hoc questionnaire to assess the acceptance of the counseling format following each counseling session (office, phone, video) in the period between July 2020 and February 2021. Results: Satisfaction and acceptance of the three counseling formats (office, phone, video) were rated (1-6) on average as "good" to "very good" in the three subgroups (1.5 ± 0.9). Likewise, the "therapeutic relationship" scored high in all three subgroups in terms of establishing a strong therapeutic relationship (4.4 ± 1.5). "Hurdles" were rated as low and tolerable (1.8 ± 1.3). The global assessment of therapeutic contact was significantly better in the video group compared to phone and office consultation (p < 0.05). Predictor analyses showed that there was an influence of age, but not gender, on the acceptance of digital counseling formats in the present sample [F (1, 277) = 4.50, p = 0.04]. Discussion & Conclusion: Digital consultation formats were perceived by patients as promising addition to the classic face-to-face setting. Digital formats (phone, video) were not generally preferred to face-to-face counseling, but especially video counseling was accepted and perceived with great satisfaction and acceptance. Accordingly, the additional use of digital counseling formats, especially video-telephony, could be an opportunity to enrich the existing structures also after the pandemic.

Illness perception and health care use in individuals with irritable bowel syndrome: results from an online survey.

BACKGROUND: Individual illness perception is known to influence a range of outcome variables. However, little is known regarding illness perception in irritable bowel syndrome (IBS) and its relation to the use of the health care system. This study hypothesised a relationship between illness perception and inappropriate health care use (under-, over- and misuse). METHODS: An internet-based, cross-sectional study in participants affected by IBS symptoms was carried out (April - October 2019) using open questions as well as validated standardized instruments, e.g. the illness perception questionnaire revised (IPQ-R) and its subscales. Sub-group comparisons were done non-parametrically and effect sizes were reported. Potential predictors of (1) conventional health care utilisation and (2) utilisation of treatment approaches with lacking or weak evidence regarding effectiveness in IBS were examined with logistic regression analyses and reported as odds ratio (OR) and 95% confidence interval. RESULTS: Data from 513 individuals were available. More than one-third (35.7%) of participants were classified as high utilisers (> 5 doctor visits during the last year). Several indicators of inappropriate health care use were detected, such as a low proportion of state-of-the-art gynaecological evaluation of symptoms (35.0% of women) and a high proportion of individuals taking ineffective and not recommended non-steroidal antirheumatic drugs for IBS (29.4%). A majority (57.7%) used treatment approaches with lacking or weak evidence regarding the effectiveness in IBS (e.g. homeopathy). Being a high utiliser as defined above was predicted by the perceived daily life consequences of IBS (IPQ-R subscale "consequences", OR = 1.189 [1.100-1.284], p ≤ 0.001) and age (OR = 0.980 [0.962-0.998], p = 0.027). The use of treatment approaches with lacking or weak evidence was forecasted by the perceived daily life consequences (OR = 1.155 [1.091-1.223], p ≤ 0.001) and gender (reference category male: OR = 0.537 [0.327-0.881], p = 0.014), however effect sizes were small. CONCLUSIONS: Daily life consequences, perceived cure and personal control as aspects of individual disease perception seem to be related to individuals' health care use. These aspects should be a standard part of the medical interview and actively explored. To face inappropriate health care use patients and professionals need to be trained. Interdisciplinary collaborative care may contribute to enhanced quality of medical supply in IBS.

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial.

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.

Web-based MINDfulness and Skills-based distress reduction in cancer (MINDS): study protocol for a multicentre observational healthcare study.

INTRODUCTION: Although a high percentage of patients with cancer experience severe psychological distress, few of them receive psycho-oncological care, largely due to barriers on the side of patients and healthcare providers that pose great challenges to delivering such care. In response, low-threshold, self-guided eHealth interventions can enable patients with cancer to deal independently and effectively with disease-related challenges and distress. Mindfulness and Skills-Based Distress Reduction in Oncology Training, nicknamed Make It Training, is one such innovative, self-guided eHealth intervention. In our study, we propose to assess different characteristics of such patients in order to define target populations for Make It Training, evaluate the intervention in terms of its usability, feasibility and sustainability and gather longitudinal data concerning the intervention's efficacy. METHODS AND ANALYSIS: Self-guided and web-based Make It Training consists of eight 30 min modules involving the use of techniques of mindfulness therapy, cognitive-behavioural therapy and acceptance and commitment therapy to be completed in a 4-month period. In our observational study, adult patients with cancer who possess adequate German language skills and provide their informed consent will be recruited at Essen, Erlangen and Tübingen University Hospitals at outpatient oncological institutions and via online channels. Patients will undergo a baseline online assessment (T0), an assessment directly after completing the intervention (T1) and assessments 3 and 6 months later (T2 and T3, respectively). With the results of those assessments, we will perform descriptive analyses of their sociodemographic and medical data, compare means and conduct regression analyses. ETHICS AND DISSEMINATION: The Ethics Committees of the University Hospitals Essen, Erlangen and Tübingen have approved the study (19-8643-BO, 27_19 B, 293/2018BO1). Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00017119.

Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study.

BACKGROUND: Peripartum depression and anxiety disorders are highly prevalent and are correlated with adverse maternal and neonatal outcomes. Antenatal care in Germany does not yet include structured screening and effective low-threshold treatment options for women facing peripartum depression and anxiety disorders. Mindfulness-based interventions (MBIs) are increasingly becoming a focus of interest for the management of such patients. Studies have shown a decrease in pregnancy-related stress and anxiety in expectant mothers following mindfulness programs. OBJECTIVE: The aim of this study was to explore the clinical effectiveness of a 1-week electronic course of mindfulness on prenatal depression and anxiety in hospitalized, high-risk pregnant women. We hypothesized that participating in a 1-week electronic MBI (eMBI) could alleviate symptoms of depression and anxiety during the hospital stay. METHODS: A prospective pilot study with an explorative study design was conducted from January to May 2019 in a sample of 68 women hospitalized due to high-risk pregnancies. After enrolling into the study, the participants were given access to an eMBI app on how to deal with stress, anxiety, and symptoms of depression. Psychometric parameters were assessed via electronic questionnaires comprising the Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI-S), and abridged version of the Pregnancy-Related Anxiety Questionnaire (PRAQ-R). RESULTS: We observed a high prevalence of peripartum depression and anxiety among hospitalized high-risk pregnant women: 39% (26/67) of the study participants in the first assessment and 41% (16/39) of the participants in the second assessment achieved EPDS scores above the cutoff value for minor/major depression. The number of participants with anxiety levels above the cutoff value (66% [45/68] of the participants in the first assessment and 67% [26/39] of the participants in the second assessment) was significantly more than that of the participants with anxiety levels below the cutoff value, as measured with the STAI-S. After completing the 1-week electronic course on mindfulness, the participants showed a significant reduction in the mean state anxiety levels (P<.03). Regarding pregnancy-related anxiety, participants who completed more than 50% of the 1-week course showed lower scores in PRAQ-R in the second assessment (P<.05). No significant changes in the EPDS scores were found after completing the intervention. CONCLUSIONS: Peripartum anxiety and depression represent a relevant health issue in hospitalized pregnant patients. Short-term eMBIs could have the potential to reduce anxiety levels and pregnancy-related anxiety. However, we observed that compliance to eMBI seems to be related to lower symptoms of pregnancy-related stress among high-risk patients. eMBIs represent accessible mental health resources at reduced costs and can be adapted for hospitalized patients during pregnancy.

Is an obesity simulation suit in an undergraduate medical communication class a valuable teaching tool? A cross-sectional proof of concept study.

OBJECTIVE: With the growing prevalence of overweight and obesity, medical students should be prepared to engage in weight management and obesity-related communications in order to prevent patients from having stigmatising experiences. In addition, medical students should have training to reduce anti-fat prejudices. DESIGN: Cross-sectional proof of concept study. SETTING: University Hospital Tuebingen, Germany. PARTICIPANTS: 246 participants (207 second-year medical students, 13 standardised patients (SPs) and 22 teachers) took part in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the assessment of degree of reality of the encounter with the SP wearing an obesity simulation suit (OSS). The secondary outcome was the evaluation of students' awareness and prejudice against patients with obesity in a simulated role play. Additionally, a description of the advantages and disadvantages when using such a teaching tool is delivered. RESULTS: The OSS contributed to a realistic perception of the patient group depicted in a role play according to students, teachers and SPs. OSS body mass index estimation by students, teachers and SPs correctly was over 30 kg/m2-thus in the range of obesity. In a selected subscale of the Anti-Fat Attitudes Test, students showed significantly stronger anti-fat stigmatisation compared with teachers and SPs. CONCLUSIONS: An OSS worn by an SP is a valuable teaching tool to raise awareness about patients with obesity. It gives a realistic picture of the encounter. Stigmatisation was low in general but was especially present in the students. Further research should include intervention studies to address this issue.