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.

A Systematic Review of the Effect of Neurofeedback in Cancer Patients.

INTRODUCTION: Neurofeedback (NF) or electroencephalogram (EEG)-Biofeedback is a drug-free form of brain training to directly alter the underlying neural mechanisms of cognition and behavior. It is a technique that measures a subject's EEG signal, processes it in real time, with the goal to enable a behavioral modification by modulating brain activity. The most common application of the NF technology is in epilepsies, migraine, attention-deficit/hyperactivity disorder, autism spectrum disorder, affective disorders, and psychotic disorders. Few studies have investigated the use of NF in context of psychosomatic illnesses. Little is known about the use in cancer patients or postcancer survivors despite the high number of this patient group. OBJECTIVES: We here provide a systematic review of the use and effect of NF on symptoms and burden in cancer patients and long-term cancer survivors. METHODS: In conducting this systematic review, we followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement. RESULTS: Our search resulted in only 3 experimental studies, 1 observational study, and 2 case reports. Given the heterogeneity of the intervention systems and protocols, no meta-analysis was conducted. CONCLUSION: Altogether, there is initial evidence that NF is a complementary, drug-free, and noninvasive therapy that has the potential to ameliorate symptoms in this patient group, such as pain, fatigue, depression, and sleep. Further studies are highly needed.

Impact of biofeedback on self-efficacy and stress reduction in obesity: a randomized controlled pilot study.

Biofeedback application is an evidence-based technique to induce relaxation. A primary mechanism of action is the improvement of self-efficacy, which is needed to facilitate the translation of health behavioral intentions into action. Obesity is often associated with low self-efficacy and dysfunctional eating patterns, including comfort eating as an inexpedient relaxation technique. This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity. In the present experiment, 31 women, mean body mass index 35.5 kg/m², were randomized to a food-specific biofeedback paradigm, a non-specific relaxation biofeedback paradigm, or a waiting list control. Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific landscape stimulus. Self-efficacy, stress, ability to relax, eating behavior, and electrodermal activity were assessed before, directly after, and 3 months after the intervention. The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress. The non-specific relaxation biofeedback showed effects on the ability to relax. Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli. Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment.

[Body image and psychiatric comorbidity in patients with somatoform gastrointestinal disorders]. / Körperbild und psychische Komorbidität bei Patienten mit somatoformen autonomen Funktionsstörungen des oberen und unteren Gastrointestinaltrakts.

OBJECTIVES: The significance of body perception and satisfaction with one's own body in patients with somatoform disorders of the upper and lower gastrointestinal tract is presently unknown, as is the relationship thereof to depression and other psychiatric comorbidities. METHODS: Consecutive patients from the outpatient clinic of a university centre presenting with symptoms suggestive of somatoform gastrointestinal disorders were examined by gastroenterological and psychosomatic experts. In addition, psychological tests (The Body Image Questionnaire, FKB-20, the Hospital Anxiety and Depression Scale, HADS-D) were carried out. RESULTS: Complete data from n = 44 patients were evaluated. In 64 % of patients we found high scores of anxiety, and in 45 % high scores of depression. In the FKB-20, 32 % of patients scored high on the "Negative Evaluation of the Body" subscale (AKB), and 96 % had low scores on the subscale "Perception of Body Dynamics" (VKD). Patients with functional bowel disorders perceived their own body significantly more negative than did healthy controls and patients after acute myocardial infarction. The AKB subscale of the FKB-20 correlated significantly and positively with anxiety in the HADS. HADS depression in turn correlated negatively with the VKD subscale of the FKB-20: Patients with low scores in depression report higher vitality. CONCLUSIONS: Nearly half of the patients with somatoform gastrointestinal disorders seen at a university centre exhibited high scores in anxiety and depression. A substantial fraction reported disturbed body perception and satisfaction with their own body image. These patients have not yet found their place between somatic medicine and psychotherapy: Although somatic und psychological symptoms coexist to a similar degree, patients tend to focus predominantly on their somatic complaints.

Effects of medical training scenarios on heart rate variability and motivation in students and simulated patients.

CONTEXT: Research regarding the experience of stress during medical training scenarios using standardised patients (SPs) has been primarily qualitative and has focused on the SPs. The purpose of this study was to quantitatively evaluate stress and motivation in both students and SPs during these scenarios by measuring heart rate variability (HRV) and administering the German version of the Questionnaire on Current Motivation (QCM). METHODS: A total of 44 medical students (23 women, 21 men) participated in two medical history-taking training scenarios. In one scenario the SP role-played a patient with a somatic disease; in the other the SP played a patient with a psychosomatic disease, creating easy and difficult scenarios, respectively, for the student. Each student interviewed one of 11 SPs (five women, six men), using the same SP in both scenarios. Heart rate variability was measured during baseline periods and during the training scenarios in both students and SPs. Motivation was assessed before each training scenario. RESULTS: Heart rate variability was lower in both students and SPs during the scenarios compared with baseline values, but did not differ by scenario type. For students, motivation increased when the first scenario involved psychosomatic illness, but decreased when the first condition was somatic. For SPs motivation was consistent over time for scenarios involving psychosomatic disease, but decreased for somatic disease-related scenarios. CONCLUSIONS: The training scenarios induced stress in both students and SPs, as indicated by decreased HRV. Student motivation was high, indicating that SP scenarios represent a valid teaching method. Further studies in the natural setting of SP examinations are needed.

Gender and the nocebo response following conditioning and expectancy.

OBJECTIVE: To investigate the role of Pavlovian conditioning and expectancy and of gender on the nocebo effects. METHODS: Conditioning experiment: Forty-eight healthy male and female volunteers were investigated for 3 days using a standard rotation procedure. Subjects in the experimental group received a salient oral stimulus prior to rotation; subjects in the control group received the stimulus 12 h after rotations on Days 1 and 2; on Day 3, all subjects received the stimulus prior to rotation. Expectancy experiment: Another 48 healthy subjects were rotated 5 x 1 min once only. All subjects received the same oral stimulus immediately prior to rotation; subjects in the experimental group were told that the symptoms might worsen with the stimulus; controls did not receive additional information. In both experiments, symptom rating (SR) and rotation tolerance (RT) were determined. RESULTS: Conditioning significantly reduced RT (P=.015) and increased SR (P=.024). For both RT and SR, a significant "day x group x gender" effect was found (P=.044; SR: P=.011) indicating that conditioning was more effective in women. Expectancies lowered RT (P=.085) without affecting SR. There was a significant "rotation x gender" interaction on RT (P=.005) indicating that the expectancy was more effective in men. CONCLUSION: Women responded stronger to conditioning while men responded to expectancies, but to a lesser degree. It needs to be determined whether this is restricted to nausea-specific conditions or can be generalized across clinical and experimental conditions.

[Self-image, real physician's and ideal physician's image: a comparison of medical students 1981 and 2006]. / Selbstbild, Arztbild und Arztideal: Ein Vergleich Medizinstudierender 1981 und 2006.

BACKGROUND: Due to the new licensing regulations for physicians, social and communicative aspects have attained a central position within medical education. In developing self-reflexive, empathetic and communicative skills, medical students are influenced on the one hand by encounters with real physicians in the role of supervisor or colleague, and on the other by their intra-psychic ideals and role stereotypes. The present study aimed to contrast the self-evaluations of modern medical students with their role stereotypes and ideals, and to further relate these to the evaluations, stereotypes and ideals of medical students in 1981. METHODS: 696 medical students were surveyed with respect to their self-image, their image of a physician and their image of the ideal physician using Osgood and Hofstätter's polarity profile. RESULTS: Over the past 25 years, medical students' image of the ideal physician has remained surprisingly constant, comprising expectations with regard to aptitude, trustworthiness, reliability, friendliness, confidence, thoroughness and congeniality. Encountered physicians were described as negatively deviating from this ideal; self-evaluations lay predominantly in between these two extremes. Self-images were characterized by feelings of powerlessness and uncertainty. CONCLUSIONS: Medical students possess differentiated images of self, future colleagues and the ideal physician. Surveyed students appeared to develop feelings of powerlessness and uncertainty, as well as tendencies to overestimate themselves within self-evaluations. Dealing with the conflict-charged domain between idealism and realism within the occupational reality toward which medical students aspire thus appears to be complicated. These problem areas, which have so far received little attention, require urgent consideration in the development of future medical curricula, in particular in the psychosocial fields.

Internet-based assessment of bowel symptoms and quality of life.

OBJECTIVES: We wished to determine the value of an open-access internet questionnaire for assessment of upper and lower gastrointestinal symptoms and health-related quality of life. METHODS: Between January 2002 and June 2005, a symptom scale for upper gastrointestinal and lower gastrointestinal symptoms was placed on a genuine website (www.gesundheits-umfrage.de) and linked to the website of the German irritable bowel syndrome patient group (www.Reizdarmselbsthilfe.de). Patients were asked to report gastrointestinal symptoms that had occurred during the last month. Patients who finished this symptoms questionnaire and acknowledged more than two of a total of eight upper gastrointestinal symptoms and/or more than two of 16 lower gastrointestinal symptoms were immediately offered the assessment of their health-related quality of life by a validated general quality of life scale--the patient general well-being inventory--a 22-item scale with six subscales (anxiety, depression, general well-being, self-control, health, and vitality) and a global scale. Total patient general well-being inventory scores and subscale values were correlated to upper gastrointestinal and lower gastrointestinal symptom scores including the Rome I definition of the irritable bowel syndrome, and to social variables. RESULTS: Five thousand two hundred and fifty-six individuals completed symptom assessment. Out of these, 4431 had three or more upper gastrointestinal symptoms, the mean number of upper gastrointestinal symptoms reported was 3.2+/-2.0; 4456 had three or more lower gastrointestinal symptoms (mean: 10.3+/-3.3), and 3187 met the Rome I criteria for irritable bowel syndrome. A total of 3316 individuals completed the patient general well-being inventory assessment (1156 men, 2160 women, mean age: 37.7+/-12.3 years). Upper gastrointestinal, lower gastrointestinal, and total symptom score were higher in women than in men (P < 0.001), and significantly correlated to the global quality of life assessment. Family status affected the symptom scores (higher in singles) and quality of life scores (lower in people living in partnership for health, but higher for vitality and depression). Age correlated negatively with upper gastrointestinal, lower gastrointestinal, and with total symptom scores as well as with some patient general well-being inventory scores. CONCLUSION: Symptom and quality of life assessment using an open internet questionnaire is feasible and generates data which are, in large, comparable to those from other sources of assessment, despite the fact that the population addressed is, on average, moderately younger than previously studied cohorts.

Functional cortical imaging of nausea and vomiting: a possible approach.

From a naive point of view, a study on functional cortical imaging of nausea and vomiting should deliver insight into the basic cortical mechanisms, connections, and time courses, of nausea and vomiting as perceived and processed in the human brain of affected subjects. Until now the brain's response to nausea and vomiting are only inadequately characterized, because studies have been focused mostly on understanding the different mechanisms leading to nausea rather than to cortical activations during nausea or vomiting, respectively. Consequently, the imaging of the "personal experience" of nausea and vomiting can currently be regarded as terra incognita. Nonetheless, the wide variety of the results published on diverse aspects of the topic can be helpful in providing guidelines for a paradigm to further investigations. This paper presents a brief outline for a study on the functional imaging of nauseated humans by means of functional magnetic resonance imaging (fMRI).

Gastric emptying effects of dietary fiber during 8 hours at two simulated cabin altitudes.

BACKGROUND: In a questionnaire survey, long-distance flying staff of a charter airline reported significantly more dyspeptic symptoms than did short-haul crewmember and ground personnel (belching: 57% vs. 37%, bloating: 51% vs. 36%). To elucidate the reason for increased frequency of gastrointestinal symptoms during long-distance flights, we investigated the effects of altitude and diet on gastric emptying, cardiovascular function, and bodily complaints. METHODS: In a 2 x 2 repeated measurement design we simulated an 8-h flight in a hypobaric chamber in 16 healthy men subjected to 2 meal conditions (high fiber vs. low fiber) on separate days, and assigned to either a flight altitude of 2500 m (8200 ft) or 1000 m (3280 ft). The subjects were blinded toward altitude. Heart rate and gastrointestinal symptoms were taken every hour, and gastric emptying was assessed by 13C-octanoic acid breath-test. In a separate experiment, we examined the effect of the two test meals (2 g vs. 20 g of fiber) in 30 healthy men under conventional laboratory conditions and found no significant differences. RESULTS: At an altitude of 2500 m, heart rate was significantly increased independent of the dietary condition. Gastric emptying (T1/2) was significantly delayed at 2500 m (8200 ft) when a high-fiber meal was given (146.3 +/- 58.4 min low fiber vs. 193.9 +/- 54.3 min high fiber). The symptom score for gastric distension (mean: 1.33 +/- 0.3 vs. mean: 1.07 +/- 0.15) and bloating (mean: 1.82 +/- 0.47 vs. mean: 1.34 +/- 0.35) were also significantly increased at 2500 m for the high-fiber meal compared with the low-fiber meal. CONCLUSIONS: Flight altitude is a physiological load. In combination with a high-fiber diet, this induces significant delays in gastric emptying that may explain symptoms of cabin and cockpit crew and passengers on long-distance flights.

Temporal characteristics of feeding behavior in the Munich miniature pig.

UNLABELLED: Correlations between meal size and inter-meal intervals as a characteristic of ingestive behavior are generally calculated utilizing Pearson's correlation coefficient. However, this commonly used method may exhibit disadvantages and methodological problems when dealing with dependent time series. Alternatively, a modified version of Pearson's r (r(diff)) or a nonparametric procedure, Pfanzagl's T combined with an expanded sampling theorem offer a statistical alternative for correlational analysis, robust to stochastic interdependencies between time series. In two studies, porcine self-initiated feeding behavior was observed in a closed economy setup, and a comparison of all three correlation coefficients was performed. STUDY 1: Twelve Munich mini-pigs were observed for 2 weeks. The rate of food ingestion was a stable characteristic of each individual pig, feeding and defecation behavior were temporally associated and light/dark cycle differences were seen for feeding. STUDY 2: Eight Munich mini-pigs were studied for 4 weeks. Kendall's Tau was utilized to test the stability of feeding behavior across weeks. Stability increased over time and feeding was more stable during the light period. Both correlation measures revealed a strong association between meal size and inter-meal intervals. CONCLUSION: Munich-miniature pigs exhibited a stable pattern of self-initiated ingestive and excretory behaviors. In both studies, Pfanzagl's T-values as well as r(diff)-values revealed a corresponding and consistent association between meal size and inter-meal intervals. In combination with the conventional Pearson's r, all three coefficients characterize different aspects of feeding behavior.