Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study.

INTRODUCTION: Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice. METHODS AND ANALYSIS: 30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring's content analysis. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23-11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial.

BACKGROUND: Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises. We expect the LightMood intervention to be superior to treatment as usual (TAU) in terms of reducing depression symptoms. METHODS: The trial incorporates four distinct measurement time points: the baseline assessment, the post-treatment assessment, and 1- and 3-month follow-up assessments. Furthermore, we implemented in-treatment assessments for both groups. Participants will be randomized into two groups (LightMood intervention vs TAU). The aim is to include 128 participants (64 per group) in the study. Inclusion criteria are patients who are obese, at least 18 years old, with a private Internet access, and with adequate digital literacy and show depression symptoms (PHQ ≥ 10). Exclusion criteria are weekly outpatient individual psychotherapy, obesity surgery within the last year or planned within the next 7 months, no private Internet access, and the prescription of a new psychotropic drug within the last 2 weeks. The primary outcome is the post-assessment reduction in depression symptoms. Secondary outcomes will include the improvement in self-efficacy, quality of life, mindfulness, reduction in eating disorder symptoms, and body mass index (BMI). Furthermore, we expect a positive development of depression symptoms throughout the different time points (T1, T2, and T3) in patients with obesity. DISCUSSION: LightMood is an evidence-based, efficient, low-threshold online intervention that aims to reduce depression symptoms in people with obesity. Online interventions could offer a promising alternative to conventional face-to-face therapy. The primary objective of the current study is to add essential insight into the feasibility, efficacy, effectiveness, and acceptance of e-mental health interventions for people with obesity and depression symptoms. TRIAL REGISTRATION: German Clinical Trial Register (DRKS), DRKS00029219. Registered on May 19, 2023.

Comparison of Palliative Knowledge and Self-Efficacy Expectation of German Paramedics Between a Rural and an Urban Structured Emergency Medical Service Area.

OBJECTIVE(S): Differences in the German emergency medical service (EMS) can be seen in the countryside in contrast to the city with regard to travel distances to hospitals and in the access routes of EMS-physicians. In order to investigate the success of establishment of palliative crisis cards associated with training and the rural and urban EMS structures, two urban and two rural EMS areas were compared using the Paramedic Palliative Care Test (PARPACT). Methods: The PARPACT includes test items on palliative knowledge (PK, maximum score: 15 points) and palliative self-efficacy expectations (PSE, maximum score: 18 points), as well as items on palliative attitudes in dealing with palliative care patients. We used a 4-point Likert-type scale. For data analysis, nonparametric tests (χ-test and Mann-Whitney U test) were used in addition to descriptive analysis (frequencies, means, medians, standard deviations, and ranges). Results: In total, 291 out of 750 ambulance or EMS personnel participated in the voluntary survey. Rural ambulance or EMS personnel answered the PK-questions correctly more often on average (mean: 11.19, SD: 1.85) than urban ambulance or EMS personnel (mean: 9.18, SD: 2.39; Mann-Whitney U test: U=5040.000, P=.001). In addition, ambulance or EMS personnel with the highest level of training (3-year-trained paramedics) performed better in PK (mean: 10.38, SD: 2.31) than less intensively training ambulance or EMS personnel (mean: 9.58, SD: 2.43; Mann-Whitney U-test: U=8446.500, P=.004). In terms of PSE, rural ambulance or EMS personnel also achieved higher mean PSE-scores (mean: 12.55, SD: 2.60) than urban ambulance or EMS personnel (mean: 9.77, SD: 3.41; Mann-Whitney U-test: U=5148.500, P=.001). Conclusions: Better training in the EMS is associated with improved PK compared to less qualified nonphysician EMS staff. The establishment of palliative crisis cards and the structures in the city alone do not lead to improved knowledge and PSE.

Anxiety and Somatoform Syndromes Predict Transplant-Focused Internet Use in the Course of an Organ Transplantation.

Background: e-Health interventions are increasing in the field of organ transplantations; however, the literature lacks evidence regarding needs, attitudes, and preferences of organ recipients and donors during the course of an organ transplantation. Methods: In a cross-sectional study, 70 subjects were assessed using self-rated and validated questionnaires, such as the PRIME MD Patient Health Questionnaire (PHQ-D) and the Essen Resource Inventory (ERI). Group differences and a multiple linear regression were also applied. Results: Organ recipients had significantly higher scores for depression (U = 245.00, z = -2.65, p = 0.008, Cohen's d = 0.32), somatoform (U = 224.50, z = -2.99, p = 0.003, Cohen's d = 0.37), and stress syndromes (U = 266.00, z = -2.25, p = 0.008, Cohen's d = 0.27). They also named the internet and apps as resources to find information regarding organ transplants (U = 177.50, z = -2.07, p = 0.017, Cohen's d = 0.28; Z = -2.308, p = 0.021) and preferred to use apps to monitor the physical condition (Z = -2.12, p = 0.034) significantly more than organ donors. Anxiety and somatoform syndromes were significant predictors to search for information regarding the transplant process (F[6,38] = 3.98, p < 0.001; R2 = 0.386). Conclusions: e-Health interventions are promising in accompanying the course of an organ transplant for patients to be informed and educated. Predominantly, potential organ recipients might benefit from apps to record physical parameters. However, anxiety syndromes might hinder patients from searching for information about the transplant process, while somatoform syndromes might enable patients who are searching for such information.

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention "mStress-IHD" trial.

BACKGROUND: Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention "mindfulHeart" in terms of reducing stress in patients with IHD. METHODS AND ANALYSIS: This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants' pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses. ETHICS: The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22-11,015-BO). TRIAL REGISTRATION: ClinicalTrials NCT05846334. Release 26.04.2023.

Depression and anxiety mediate the relationship between illness representations and perceived distress in patients with chronic pain.

Illness representations explain the individual's perception and processing of health-related information. In a chronic condition such as persistent pain, illness representations might influence treatment adherence and outcome. This study aims to exploratively identify illness representations of patients with chronic pain and their association to mental disorders and subjective distress. 95 participants admitted to an inpatient university clinic were included. Validated instruments were used to assess illness representations (IPQ-R), mental health disorders (PHQ-D), and subjective distress (PSQ). Sociodemographic data and scores for the instruments were first inspected descriptively. Correlation, regression, and mediator analyses were conducted. Analyses indicated that the distributions of the IPQ-R range toward higher values. In regard to mental disorders (PHQ-D) and subjective distress (PSQ), we found several significant correlations with subscales of the IPQ-R. A regression analysis showed the IPQ-R subscales personal control, emotional representation and sex (males) to be significant predictors of subjective distress measured with the PSQ (F(11,86) = 11.55, p < .001, adjusted R2 = 0.545). Depression, anxiety, and stress syndromes (PHQ-D) significantly mediated the positive association between emotional representations (IPQ-R, predictor) and subjective distress (PSQ, outcome) with a total effect of c = .005, 95% CI [.005; .129]. Illness representations play a significant role in evaluating patients' subjective distress and mental health. It is advised to incorporate illness representations into standard protocols for psychological interventions to comprehend their influence on targeted therapeutic strategies, particularly those tailored for pain management.

Development and psychometric evaluation of the Man-Made Disaster-Related Distress Scale (MMDS).

Man-made disasters (MMD2) are a widespread cause for psychological burden, both in directly and indirectly affected regions, as currently highlighted by the Russian invasion of Ukraine. Yet, measurement instruments that assess psychological distress associated with MMD are lacking. The study aimed to develop and validate such an instrument in an indirectly affected region. The resulting "man-made disaster-related distress scale" (MMDS) was tested within a German-speaking sample (N = 327). Exploratory and confirmatory factor analysis revealed a two-factorial structure ("Psychological distress" and "Change of existing belief systems") of the MMDS. The confirmatory model had an acceptable to good fit with CFI/TLI higher than 0.90. Internal consistency of the MMDS and its subscales was high with α and ω higher than 0.80. Correlational analyses suggested convergent, discriminant, and criterion validity. Measurement invariance was confirmed for gender and age with a change in CFI smaller than 0.01 but was rejected for educational level. The MMDS resulted in a 14-item assessment instrument based on a 7-point Likert-scale with good psychometric properties. Its administration is readily and economical, yielding the option to be used as a standardized measurement tool.

Needs and Demands for eHealth Pain Management Interventions in Chronic Pain Patients.

Although chronic pain is a global health problem, the current care situation is often inadequate. eHealth offers many advantages as an additional option for treating chronic pain. Yet, an intervention's efficacy can only be fully exhausted if patients intend to use it. This study aims to identify the needs and demands of patients with chronic pain regarding intervention concepts and frameworks to develop specifically tailored eHealth pain management interventions. A cross-sectional study was conducted, including 338 individuals with chronic pain. Within the cohort, a distinction between a high- and a low-burden group was made. Respondents generally preferred a permanently accompanying mobile app, but the preferred content varied with group. According to the majority, interventions should be made available on smartphones, offer sessions once per week with a duration from 10 to 30 min, and be recommended by experts. These results can provide the basis for future eHealth pain management interventions tailored to the patients' needs and demands.

The SARS-CoV-2 pandemic causes a dysfunctional dietary behavior: A German cross-sectional study.

Background: Since the COVID-19 pandemic has been affected our daily lives, the global population has been exposed to permanent concerns and thus might suffer from the psychological burden. It is well known that psychological burdens can affect dietary behavior. Aim: The impact of a psychological burden on people, and in particular on their dietary patterns was investigated in this nationawide cross-sectional study. Methods: 7525 participants responded to the questionnaire regarding the psychological burden concerning the COVID-19 pandemic and their current dietary structure with changes in the pattern and food amount (between November 2020 and March 2021). Results: A pandemic-related dysfunction of dietary behavior was found. Some participants reported restrictive (conscious) food intake and as well impulsive food intake, which can be described as dysfunctional eating behaviors. In particular, younger persons and individuals who claimed an increased psychological burden reported dysfunctional dietary behavior. Data clearly show that psychological burdens affect an individual's dietary behavior. Conclusion: Public health strategies have to be developed to support individuals at risk to improve coping strategies. The long-term aim should be avoiding the maintenance of dysfunctional dietary behavior.

Fear of Death during COVID-19 Does Not Explain Post-Infection Depression Symptoms beyond Reported Symptoms during the Infection in COVID-19 Survivors.

The COVID-19 pandemic poses an unprecedented global burden to the general population and, in particular, to individuals who have been infected with SARS-CoV-2. In the context of the discussion about "post COVID-19", the aim of the study was to advance research on mental health and long-term consequences after COVID-19. In total, 214 COVID-19 survivors (female: 54.2%; hospitalized: 36.7%) participated in the repeated cross-sectional assessment. In addition to demographic data, mental and somatic symptoms, fear of death at the time of infection, and depressive (PHQ-8) and generalized anxiety symptoms (GAD-7) were assessed. Results showed an increased prevalence of depressive symptoms and symptoms of generalized anxiety compared to observations in the general population prior to the COVID-19 pandemic. Psychological symptoms of depression and reported levels of fear of death during the SARS-CoV-2 infection showed a negative association with the time interval since COVID-19 diagnosis. Furthermore, although fear of death during the acute COVID-19 was related to depression and generalized anxiety, this association was predominantly explained by the presence of mental and somatic symptoms. In conclusion, initial fear of death does not impact mental health beyond the overall symptom burden. Furthermore, depressive symptoms appear to vanish across time since infection.

Post-COVID-19 Syndrome is Rarely Associated with Damage of the Nervous System: Findings from a Prospective Observational Cohort Study in 171 Patients.

INTRODUCTION: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can affect multiple organs. Reports of persistent or newly emergent symptoms, including those related to the nervous system, have increased over the course of the pandemic, leading to the introduction of post-COVID-19 syndrome. However, this novel syndrome is still ill-defined and structured objectification of complaints is scarce. Therefore, we performed a prospective observational cohort study to better define and validate subjective neurological disturbances in patients with post-COVID-19 syndrome. METHODS: A total of 171 patients fulfilling the post-COVID-19 WHO Delphi consensus criteria underwent a comprehensive neurological diagnostic work-up including neurovascular, electrophysiological, and blood analysis. In addition, magnetic resonance imaging (MRI) and lumbar puncture were conducted in subgroups of patients. Furthermore, patients underwent neuropsychological, psychosomatic, and fatigue assessment. RESULTS: Patients were predominantly female, middle-aged, and had incurred mostly mild-to-moderate acute COVID-19. The most frequent post-COVID-19 complaints included fatigue, difficulties in concentration, and memory deficits. In most patients (85.8%), in-depth neurological assessment yielded no pathological findings. In 97.7% of the cases, either no diagnosis other than post COVID-19 syndrome, or no diagnosis likely related to preceding acute COVID-19 could be established. Sensory or motor complaints were more often associated with a neurological diagnosis other than post-COVID-19 syndrome. Previous psychiatric conditions were identified as a risk factor for developing post-COVID-19 syndrome. We found high somatization scores in our patient group that correlated with cognitive deficits and the extent of fatigue. CONCLUSIONS: Albeit frequently reported by patients, objectifiable affection of the nervous system is rare in post-COVID-19 syndrome. Instead, elevated levels of somatization point towards a pathogenesis potentially involving psychosomatic factors. However, thorough neurological assessment is important in this patient group in order to not miss neurological diseases other than post-COVID-19.

COVID-19-Related Burden and Risk Perception in Individuals with Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy: A Cross-Sectional Study.

INTRODUCTION: This study investigated the mental health burden of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN) during the COVID-19 pandemic in comparison to matched healthy controls. METHODS: The cross-sectional study included 59 patients with a diagnosis of either CIDP or MMN and 59 propensity score matched healthy controls. All participants completed a survey including demographics, distress (distress thermometer), depressive symptoms (PHQ-2), generalized anxiety (GAD-7), COVID-19-related fear, and risk perception. Additionally, patients with CIDP or MMN were asked about the frequency and type of infections since treatment initiation. RESULTS: Patients with either CIDP or MMN reported experiencing reduced frequency or no differences in infection frequency since immune medication was initiated. Regarding COVID-19, patients with CIDP or MMN rated their risk of infection similar to healthy controls, while they expected a higher probability of the occurrence of symptoms, severe course, and dying of COVID-19. They reported increased depressive symptoms, generalized anxiety, and COVID-19-related fear in comparison to healthy controls. CONCLUSION: Despite their personal experience of reduced frequency of infection since immune medication was initiated, patients with CIDP or MMN reported increased risk perception and prevalence of depressive symptoms, generalized anxiety, and COVID-19-related fear in comparison to healthy controls. This highlights the need for evidence-driven strategies to protect the mental health of this vulnerable group.

Increased Safety Behavior and COVID-19-Related Fear in Adults with Cystic Fibrosis during the Pandemic.

People with cystic fibrosis (pwCF) face great challenges during the ongoing COVID-19 pandemic. Recent research found equal levels of distress in pwCF and healthy controls (HC). The current study aimed to investigate the mental health burden and safety behavior in pwCF. Sixty-nine adult pwCF and sixty-nine propensity-score-matched HC participated in this study. Participants completed an anonymous online questionnaire assessing distress, generalized anxiety, depressive symptoms, COVID-19-related variables, self-reported adherent safety behavior (ASB), and dysfunctional safety behavior (DSB). PwCF showed equal amounts of distress (W = 2481.0, p = 0.669), depressive symptoms (W = 2632.5, p = 0.268), and generalized anxiety symptoms (W = 2515.5, p = 0.565) compared to the HC. COVID-19-related fear (W = 1872.0, p = 0.028), ASB (W = 1630.0, p = 0.001), and DSB (W = 1498.5, p < 0.001) were significantly elevated in pwCF. The pwCF estimated that the probability of suffering from symptoms (W = 954.5, p < 0.001), experiencing a severe course (W = 806.5, p < 0.001), or dying (W = 1079.0, p < 0.001) from COVID-19 is significantly higher than that of the HC. ASB was associated with a CF diagnosis, COVID-19-related fear, and a subjective level of information (R2 = 0.414, F(13, 124) = 6.936, p ≤ 0.001). DSB was associated with a diagnosis of CF and COVID-19-related fear (R2 = 0.196, F(13, 124) = 3.169, p ≤ 0.001). The data suggest that pwCF show functional and adequate behaviors towards the risk caused by the pandemic. Therefore, functional coping behaviors may provide advantages in addressing pandemic challenges.

Predicting Acceptance of e-Mental Health Interventions in Patients With Obesity by Using an Extended Unified Theory of Acceptance Model: Cross-sectional Study.

BACKGROUND: The rapid increase in the number of people who are overweight and obese is a worldwide health problem. Obesity is often associated with physiological and mental health burdens. Owing to several barriers to face-to-face psychotherapy, a promising approach is to exploit recent developments and implement innovative e-mental health interventions that offer various benefits to patients with obesity and to the health care system. OBJECTIVE: This study aims to assess the acceptance of e-mental health interventions in patients with obesity and explore its influencing predictors. In addition, the well-established Unified Theory of Acceptance and Use of Technology (UTAUT) model is compared with an extended UTAUT model in terms of variance explanation of acceptance. METHODS: A cross-sectional web-based survey study was conducted from July 2020 to January 2021 in Germany. Eligibility requirements were adult age (≥18 years), internet access, good command of the German language, and BMI >30 kg/m2 (obesity). A total of 448 patients with obesity (grades I, II, and III) were recruited via specialized social media platforms. The impact of various sociodemographic, medical, and mental health characteristics was assessed. eHealth-related data and acceptance of e-mental health interventions were examined using a modified questionnaire based on the UTAUT. RESULTS: Overall, the acceptance of e-mental health interventions in patients with obesity was moderate (mean 3.18, SD 1.11). Significant differences in the acceptance of e-mental health interventions among patients with obesity exist, depending on the grade of obesity, age, sex, occupational status, and mental health status. In an extended UTAUT regression model, acceptance was significantly predicted by the depression score (Patient Health Questionnaire-8; ß=.07; P=.03), stress owing to constant availability via mobile phone or email (ß=.06; P=.02), and confidence in using digital media (ß=-0.058; P=.04) and by the UTAUT core predictors performance expectancy (ß=.45; P<.001), effort expectancy (ß=.22; P<.001), and social influence (ß=.27; P<.001). The comparison between an extended UTAUT model (16 predictors) and the restrictive UTAUT model (performance expectancy, effort expectancy, and social influence) revealed a significant difference in explained variance (F13,431=2.366; P=.005). CONCLUSIONS: The UTAUT model has proven to be a valuable instrument to predict the acceptance of e-mental health interventions in patients with obesity. The extended UTAUT model explained a significantly high percentage of variance in acceptance (in total 73.6%). On the basis of the strong association between acceptance and future use, new interventions should focus on these UTAUT predictors to promote the establishment of effective e-mental health interventions for patients with obesity who experience mental health burdens.

Levels, Predictors, and Distribution of Interpersonal Solidarity during the COVID-19 Pandemic.

Since introducing the first non-pharmaceutical interventions (NPIs) to decelerate the spread of the virus, European governments have highlighted the role of "solidarity". However, the role and levels of solidarity, especially during the past lockdowns, is uncertain. The present study thus explores the levels, the role, and the distribution of received and demonstrated interpersonal solidarity during the COVID-19 pandemic. This pooled cross-sectional study was conducted from March 2020 to March 2021 in Germany, including 19,977 participants. Levels of solidarity between the first and the second lockdowns in Germany were compared, possible predictors were examined, and three clusters were defined to unveil distributional patterns of solidarity reception and/or demonstration. To compare solidarity levels between the first and the second lockdowns in Germany, a dummy-coded lockdown variable was introduced and regressed on the two solidarity items. To identify predictors of received and demonstrated solidarity, two multiple linear regression models were computed, testing several demographic and psychological factors. For further exploratory analyses, clusters of "helpers", "non-helpers", and "help-receivers and helpers" were computed based on a k-means cluster analysis. Results revealed a lower level of solidarity during the second lockdown compared with the first one. Demonstrated solidarity was positively predicted by adherent safety behavior to avoid COVID-19 infection and by middle age, and negatively by depression symptoms, male gender, and high age. Received solidarity was positively predicted by higher age, by both adherent and dysfunctional safety behavior in avoidance of COVID-19 infection, and by lower educational level. "Helpers" reported little received solidarity but demonstrated high solidarity, "non-helpers" showed both little demonstrated and received solidarity, and "help-receivers and helpers" showed middle-high received and demonstrated solidarity. The three clusters differed the most regarding the variables of age, adherent and dysfunctional safety behavior, fear of COVID-19, subjective risk perceptions regarding contraction of COVID-19 and the respective consequences, and trust in governmental interventions in response to COVID-19. The decrease in interpersonal solidarity over the course of the COVID-19 pandemic, as well as its predictors, should be considered regarding prospective impositions. Furthermore, as depressive symptoms were identified to negatively predict interpersonal solidarity, the adequate provision of mental health services, especially during the COVID-19 pandemic, becomes even more important.

Metabolic Surgery Supporting Aftercare via Group-Intervention (MeSSAGES): study protocol of a randomised controlled trial.

INTRODUCTION: Obesity is a constantly rising and cost-intensive medical issue worldwide. Severe obesity often needs surgery to promote weight loss, but due to the rapid therapeutic success after the surgery, many patients lack the awareness of the need to consistently maintain the postoperative care. However, therapeutic success and psychological well-being can be increased through group interventions and social support of the group members. Therefore, aftercare via group intervention is a promising approach. In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested. METHODS AND ANALYSIS: The intervention group will complete a social media-supported group intervention for 6 weeks with weekly postings of educative contents and the possibility to exchange in groups via anonymous avatars. The control group will receive treatment as usual (TAU) after the obesity surgery as recommended in the German S3-guidelines Obesity Surgery and Metabolic Surgery. We will examine the effectiveness of a social media-supported intervention group, and therefore, the change in self-efficacy expectation. For the primary outcome, we will perform a mixed analysis of variance with time as the within-subject factor (times of measurement T0-T4) and the group assignment as the between-subject factor (intervention +TAU vs TAU group). ETHICS AND DISSEMINATION: The study was approved by the Medical Association North Rhine (Ärztekammer Nordrhein, 2020031) and the patient enrolment will begin in July 2021. TRIAL REGISTRATION NUMBER: DRKS00018089.

Evaluation of the E-Mental Health Mindfulness-Based and Skills-Based "CoPE It" Intervention to Reduce Psychological Distress in Times of COVID-19: Results of a Bicentre Longitudinal Study.

Background: The SARS-CoV-2 pandemic poses immense challenges for health care systems and population-wide mental health. The e-mental health intervention "CoPE It" has been developed to offer standardized and manualized support to overcome psychological distress caused by the pandemic. The aim of this study was to assess the effectiveness of "CoPE It" in terms of reducing distress (primary outcome), depression and anxiety symptoms, and improving self-efficacy, and mindfulness (secondary outcomes). Furthermore, the intervention's usability, feasibility, and participants' satisfaction with "CoPE It" was evaluated (tertiary outcome). The study protocol has been published previously. Methods: A bicentre longitudinal study was conducted from April 27th 2020 to May 3rd 2021. N = 110 participants were included in the analyses. The intervention consisted of four modules featuring different media promoting evidence-based methods of cognitive behavioral therapy and mindfulness-based stress reduction. Difference in psychological distress between baseline (T0) and post-intervention (T1) were analyzed by repeated measure analysis of covariance. Mixed linear models were applied to assess moderating effects. Depressive symptoms, generalized anxiety symptoms, self-efficacy, and mindfulness were compared between baseline (T0) and post-intervention (T1) via t-tests. Usability of the "CoPE It" intervention and participants' satisfaction was evaluated by calculation means and frequencies. Results: Primary outcome: A significant effect of time on psychological distress at post-intervention (T1) after controlling for age, gender, education, mental illness and attitudes toward online interventions was found. Depressive and anxiety symptoms, and mindfulness were a significant moderators of the relationship between time and psychological distress for consistent wording. Secondary outcomes: There was a significant decrease in depressive symptoms and generalized anxiety, and a significant increase in self-efficacy and mindfulness between baseline (T0) and post-intervention (T1). Tertiary outcomes: 95.83% of the participants thought the "CoPE It" intervention was easy to use and 87.50% were satisfied with the "CoPE It" intervention in an overall, general sense. Conclusion: The e-mental health "CoPE It" intervention seems to be an effective approach in reducing psychological distress, anxiety and depressive symptoms, and in enhancing self-efficacy and mindfulness during the COVID-19 pandemic. Participants' satisfaction and the program's feasibility, and usability were proven to be high. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: DRKS00021301.

Mental health burden of patients with diabetes before and after the initial outbreak of COVID-19: predictors of mental health impairment.

BACKGROUND: The COVID-19 pandemic is affecting people's mental health worldwide. Patients with diabetes are at risk for a severe course of illness when infected with SARS-CoV-2. The present study aims to retrospectively examine mental health changes in patients with diabetes in Germany before and after the initial COVID-19 outbreak, and to furthermore explore potential predictors of such changes. METHODS: Over the course of eight weeks from April to June 2020, 253 individuals diagnosed with diabetes participated in an online cross-sectional study. Participants completed an anonymous survey including demographics, depression (PHQ-2) and generalized anxiety symptoms (GAD-2), distress (DT), and health status (EQ-5D-3L). In addition, all instruments used were modified to retrospectively ask participants to recall their mental health and health status before the outbreak had started. Additionally examined factors were COVID-19-related fear, trust in governmental actions to face the pandemic, and the subjective level of information about COVID-19. RESULTS: This study shows a significant increase in prevalence of depression symptoms, generalized anxiety symptoms and distress, as well as significantly decreased health statuses in diabetes patients after the initial COVID-19 outbreak. Increased depression symptoms, generalized anxiety symptoms and distress were predicted by COVID-19-related fear, whereas trust in governmental actions to face COVID-19 predicted higher depression symptoms. CONCLUSIONS: The results indicate a negative impact of the initial COVID-19 outbreak on mental health and health status in patients with diabetes. In order to improve the efficacy of psychological support strategies for diabetes patients during the pandemic, possible predictors of mental health impairment such as the aforementioned should be examined more thoroughly and addressed more openly.

Generalized Anxiety as a Risk Factor for Dysfunctional Eating Behavior after Obesity Surgery during the COVID-19 Pandemic.

Purpose: The present study investigates the impact of obesity surgery on mental health (i.e., eating behavior and distress) during the COVID-19 pandemic. Methods: Two hundred fifty-four participants were recruited via social media. One hundred fourteen (44.53%) of them were surgery candidates (waiting for obesity surgery), while 142 (55.46%) had already undergone surgery. Participants who underwent surgery were compared to participants that did not yet undergo surgery in terms of mental burden (depression and anxiety), as well as safety and eating behavior. Further moderation analyses attempted to identify risk factors for increased COVID-19-related dysfunctional eating behavior after surgery. Results: Participants who underwent surgery showed generally lower levels of depression and general anxiety on a trend level. Moderation analyses suggested that people with high levels of generalized anxiety actually show more dysfunctional COVID-19-specific eating behavior after obesity surgery. Conclusion: On a trend level, obesity surgery appears to attenuate symptoms of generalized anxiety and depression. Yet, surgery patients with high levels of generalized anxiety exhibit even higher levels of dysfunctional eating during the COVID-19 pandemic. It is therefore particularly important to support people at risk.