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.

Implementing biofeedback treatment in a psychosomatic-psychotherapeutic inpatient unit: a mixed methods evaluation of acceptance, satisfaction, and feasibility.

Introduction: Feedback-based therapies such as biofeedback have a benefit in patients with mental health disorders. While biofeedback is heavily researched in outpatient settings, it has been rarely investigated in psychosomatic inpatient settings. The implementation of an additional treatment option in inpatient settings holds special requirements. The aim of this pilot study is the evaluation of additional biofeedback treatment in an inpatient psychosomatic-psychotherapeutic unit to derive clinical implications and recommendations for the future implementation of biofeedback offers. Methods: The evaluation of the implementation process was investigated using a convergent parallel mixed methods approach (following MMARS guidelines). Quantitative questionnaires measured patients' acceptance and satisfaction with biofeedback treatment after receiving 10 sessions in addition to treatment as usual. After 6 months during implementation, qualitative interviews were conducted with biofeedback practitioners, i.e., staff nurses, examining acceptance and feasibility. Data analysis was conducted using either descriptive statistics or Mayring's qualitative content analysis. Results: In total, 40 patients and 10 biofeedback practitioners were included. Quantitative questionnaires revealed high satisfaction and acceptance in patients regarding biofeedback treatment. Qualitative interviews showed high acceptance in biofeedback practitioners but revealed several challenges that were encountered during the implementation process, e.g., increased workload due to additional tasks, organizational and structural difficulties. However, biofeedback practitioners were enabled to expand their own competencies and take over a therapeutic part of the inpatient treatment. Discussion: Even though patient satisfaction and staff motivation are high, the implementation of biofeedback in an inpatient unit requires special actions to be taken. Not only should personnel resources be planned and available in advance of implementation but also be the workflow for biofeedback practitioners as easy and quality of biofeedback treatment as high as possible. Consequently, the implementation of a manualized biofeedback treatment should be considered. Nevertheless, more research needs to be done about suitable biofeedback protocols for this patient clientele.

Neurofeedback Treatment Affects Affective Symptoms, But Not Perceived Cognitive Impairment in Cancer Patients: Results of an Explorative Randomized Controlled Trial.

BACKGROUND: EEG biofeedback (NF) is an established therapy to enable individuals to influence their own cognitive-emotional state by addressing changes in brainwaves. Psycho-oncological approaches of NF in cancer patients are rare and effects are hardly studied. OBJECTIVE: The aim of this explorative, randomized controlled trial was to test the effectiveness of an alpha and theta NF training protocol, compared to mindfulness based therapy as an established psycho-oncological treatment. METHODS: Of initially 62 screened patients, 56 were included (inclusion criteria were cancer independent of tumor stage, age >18 years, German speaking; exclusion criteria suicidal ideation, brain tumor). Randomization and stratification (tumor stage) was conducted by a computer system. Participants got 10 sessions over 5 weeks, in (a) an NF intervention (n = 21; 13 female, 8 male; MAge = 52.95(10 519); range = 31 to 73 years)) or (b) a mindfulness group therapy as control condition (CG; n = 21; ie, 15 female, 6 male; MAge = 50.33(8708); range = 32 to 67 years)). Outcome parameters included self-reported cognitive impairment (PCI) as primary outcome, and secondary outcomes of emotional distress (DT, PHQ-8, GAD-7), fatigue (MFI-20), rumination (RSQ), quality of life (QoL, EORTC-30 QoL), self-efficacy (GSE), and changes in EEG alpha, and theta-beta band performance in the NF condition. RESULTS: No changes in cognitive impairment were found (P = .079), neither in NF nor CG. High affective distress was evident, with 70.7% showing elevated distress and 34.1% showing severe depressive symptoms. Affective symptoms of distress (P ≤ .01), depression (P ≤ .05) and generalized anxiety (P ≤ .05) decreased significantly over time. No differences between NF and CG were found. There was a significant increase of the alpha band (P ≤ .05; N = 15) over the NF sessions. Self-efficacy predicted QoL increase in NF with P ≤ .001 and an explained variance of 48.2%. CONCLUSION: This is the first study to investigate NF technique with regard to basic mechanisms of effectiveness in a sample of cancer patients, compared to an established psycho-oncological intervention in this field. Though there were no changes in cognitive impairment, present data show that NF improves affective symptoms comparably to mindfulness-based therapy and even more pronounced in QoL and self-efficacy.Trial registration: ID: DRKS00015773.

Cancer Patients' Age-Related Benefits from Mobile Neurofeedback-Therapy in Quality of Life and Self-efficacy: A Clinical Waitlist Control Study.

Electroencephalographic neurofeedback (EEG NF) can improve quality of life (QoL) and reduce distress by modifying the amplitude of selected brain frequencies. This study aims to investigate the effects of NF therapy on QoL and self-efficacy in cancer patients and to explore age-related reactions. In a waitlist control paradigm, psychometric data (EORTC QLQ-C30, General Self-Efficacy Scale) of 20 patients were collected at three different time points, each five weeks apart. An outpatient 10-session NF intervention (mobile) was conducted between the second and third measurement point. QoL and self-efficacy changed significantly over time (QoL: F(2,36) = 5.294, p < .05, η2 = .227; Self-efficacy: F(2,26) = 8.178, p < .05, η2 = .386). While QoL increased in younger patients, older patients initially showed a decrease in QoL, which then increased during intervention. Younger patients did not differ from older patients in QoL in both waitlist control (T0-T1) and intervention phase (T1-T2). QoL in older patients significantly differed between waitlist control and intervention phase (Z = - 2.023, p < .05, d = 1.085). Self-efficacy increased in both age categories. Younger and older patients did not differ in self-efficacy in waitlist control, but in intervention phase (F(1,16) = 7.014, p < .05, η2 = .319). The current findings suggest that NF therapy is a promising treatment modality for improving QoL in cancer patients. Our study reveals NF being a tool to influence self-efficacy, which should receive more appreciation in clinical care. However, the effect of NF in different age groups as well as the influence on further cancer-related symptoms should be investigated in future research.

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.

COVID-19-Fear Affects Current Safety Behavior Mediated by Neuroticism-Results of a Large Cross-Sectional Study in Germany.

Objectives: Although many research studies concerning changes in personality and behavior in time of COVID-19 pandemic emerged, important questions still have not been answered. This study with a large sample aimed to give insights into the impact of personality on pandemic fear and behavior by investigating the Big Five traits, COVID-19-fear, and associated behavioral changes in a large German-speaking sample. Methods: About 14,048 healthy respondents (65.5% female, 34.2% male, and 0.32% other gender/gender queer; range = 18-85 years, median age 35-44 years) participated in the survey during the COVID-19 pandemic. Two scales, "adherent" safety behavior (ASB, α = 0.857) and "dysfunctional" safety behavior (DSB, α = 0.876), three items each, measured pandemic-associated behavior. The Big Five Inventory-10 (BFI-10) tested personality traits. Results: While ASB correlated negatively with extraversion (rho = -0.053, ≤ 0.001), the other four traits were positively associated, with the highest association for neuroticism (rho = 0.116, ≤ 0.001), whereas neuroticism showed a positive correlation (rho = 0.142, ≤ 0.001) with DSB, extraversion (rho = -0.042, ≤ 0.001), agreeableness (rho = -0.028, ≤ 0.001), and conscientiousness (rho = -0.025, ≤ 0.001) correlated negatively with it. Regression analyses showed a small extent of the effect of personality traits. Moreover, neuroticism mediated the association between COVID-19-fear and DSB (positive-directed). Conclusions: Even though our results on correlations between personality, pandemic fear, and related behavior are in line with the existing literature studies, the analyses clearly show that the impact of personality traits, including neuroticism, on pandemic behavior is very small. Rather, pandemic fear has a much larger influence on the safety behavior mediated through neuroticism. Further studies should bear in mind that personality traits can not only have influencing effects but also mediating effects.

Determining Acceptance of e-Mental Health Interventions in Digital Psychodiabetology Using a Quantitative Web-Based Survey: Cross-sectional Study.

BACKGROUND: Diabetes is a very common chronic disease that exerts massive physiological and psychological burdens on patients. The digitalization of mental health care has generated effective e-mental health approaches, which offer an indubitable practical value for patient treatment. However, before implementing and optimizing e-mental health tools, their acceptance and underlying barriers and resources should be first determined for developing and establishing effective patient-oriented interventions. OBJECTIVE: This study aims to assess the acceptance of e-mental health interventions among patients with diabetes and explore its underlying barriers and resources. METHODS: A cross-sectional study was conducted in Germany from April 9, 2020, to June 15, 2020, through a web-based survey for which patients were recruited via web-based diabetes channels. The eligibility requirements were adult age (18 years or older), a good command of the German language, internet access, and a diagnosis of diabetes. Acceptance was measured using a modified questionnaire, which was based on the well-established Unified Theory of Acceptance and Use of Technology (UTAUT) and assessed health-related internet use, acceptance of e-mental health interventions, and its barriers and resources. Mental health was measured using validated and established instruments, namely the Generalized Anxiety Disorder Scale-7, Patient Health Questionnaire-2, and Distress Thermometer. In addition, sociodemographic and medical data regarding diabetes were collected. RESULTS: Of the 340 participants who started the survey, 261 (76.8%) completed it and the final sample comprised 258 participants with complete data sets. The acceptance of e-mental health interventions in patients with diabetes was overall moderate (mean 3.02, SD 1.14). Gender and having a mental disorder had a significant influence on acceptance (P<.001). In an extended UTAUT regression model (UTAUT predictors plus sociodemographics and mental health variables), distress (ß=.11; P=.03) as well as the UTAUT predictors performance expectancy (ß=.50; P<.001), effort expectancy (ß=.15; P=.001), and social influence (ß=.28; P<.001) significantly predicted acceptance. The comparison between an extended UTAUT regression model (13 predictors) and the UTAUT-only regression model (performance expectancy, effort expectancy, social influence) revealed no significant difference in explained variance (F10,244=1.567; P=.12). CONCLUSIONS: This study supports the viability of the UTAUT model and its predictors in assessing the acceptance of e-mental health interventions among patients with diabetes. Three UTAUT predictors reached a notable amount of explained variance of 75% in the acceptance, indicating that it is a very useful and efficient method for measuring e-mental health intervention acceptance in patients with diabetes. Owing to the close link between acceptance and use, acceptance-facilitating interventions focusing on these three UTAUT predictors should be fostered to bring forward the highly needed establishment of effective e-mental health interventions in psychodiabetology.

Mental Health Burden of German Cancer Patients before and after the Outbreak of COVID-19: Predictors of Mental Health Impairment.

The aim of this study was to analyze individual changes in cancer patients' mental health before and after the COVID-19 outbreak, and to explore predictors of mental health impairment. Over a two-week period (16-30 March 2020), 150 cancer patients in Germany participated in this study. Validated instruments assessed demographic and medical data, depression and anxiety symptoms (PHQ-2, GAD-2), distress (DT), and health status (EQ-5D-3L). All instruments were adapted to measure the individual mental health before the COVID-19 outbreak. COVID-19-related fear, trust in governmental actions to face COVID-19, and the subjective level of information regarding COVID-19 were measured. Cancer patients showed a significant increase in depression and anxiety symptoms and distress, while health status deteriorated since the COVID-19 outbreak. Increased depression and generalized anxiety symptoms were predicted by COVID-19-related fear. Trust in governmental actions to face COVID-19 and COVID-19-related fear predicted increases in distress. Higher subjective levels of information predicted less increasing anxiety symptoms and distress. Present data suggests that cancer patients experienced a significant increase in mental health burden since the COVID-19 outbreak. Observed predictors of mental health impairment and protective factors should be addressed, and appropriate interventions established, to maintain mental health of cancer patients during the pandemic.

[Morphology of low-velocity impact stains produced from single drops of blood]. / Zur Morphologie langsam beschleunigter Blutauftropfspuren.

Systematic variation of blood droplet volume, the distance fallen and the surface (paper, wood, plastics, tiles) led to the conclusion that the size and the shape of the stains ("fingers", satellites) allowed to deduce the distance fallen but only if the actual surface structure was known. We found that detailed photography at the crime scene was necessary, yet experiments have to be performed due to the extreme influence of the actual surface texture on all characteristics (size, spines, peripheral spatter) of the blood stains.