Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study.

Mindfulness witnessed a substantial popularity surge in the past decade, especially as digitally self-administered interventions became available at relatively low costs. Yet, it is uncertain whether they effectively help reduce stress. In a preregistered (OSF https://doi.org/10.17605/OSF.IO/UF4JZ ; retrospective registration at ClinicalTrials.gov NCT06308744 ) multi-site study (nsites = 37, nparticipants = 2,239, 70.4% women, Mage = 22.4, s.d.age = 10.1, all fluent English speakers), we experimentally tested whether four single, standalone mindfulness exercises effectively reduced stress, using Bayesian mixed-effects models. All exercises proved to be more efficacious than the active control. We observed a mean difference of 0.27 (d = -0.56; 95% confidence interval, -0.43 to -0.69) between the control condition (M = 1.95, s.d. = 0.50) and the condition with the largest stress reduction (body scan: M = 1.68, s.d. = 0.46). Our findings suggest that mindfulness may be beneficial for reducing self-reported short-term stress for English speakers from higher-income countries.

Modulation of human frontal midline theta by neurofeedback: A systematic review and quantitative meta-analysis.

Human brain activity consists of different frequency bands associated with varying functions. Oscillatory activity of frontal brain regions in the theta range (4-8 Hz) is linked to cognitive processing and can be modulated by neurofeedback - a technique where participants receive real-time feedback about their brain activity and learn to modulate it. However, criticism of this technique evolved, and high heterogeneity of study designs complicates a valid evaluation of its effectiveness. This meta-analysis provides the first systematic overview over studies attempting to modulate frontal midline theta with neurofeedback in healthy human participants. Out of 1261 articles screened, 14 studies were eligible for systematic review and 11 for quantitative meta-analyses. Studies were evaluated following the DIAD model and the PRISMA guidelines. A significant across-study effect of medium size (Hedges' g = .66; 95%-CI [-0.62, 1.73]) with substantial between-study heterogeneity (Q(16) = 167.43, p < .001) was observed and subanalysis revealed effective frontal midline theta upregulation. We discuss moderators of effect sizes and provide guidelines for future research in this dynamic field.

Patient-reported outcomes provide evidence for increased depressive symptoms and increased mental impairment in giant cell arteritis.

Objectives: The spectrum of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) represents highly inflammatory rheumatic diseases. Patients mostly report severe physical impairment. Possible consequences for mental health have been scarcely studied. The aim of this study was to investigate psychological well-being in the context of GCA and PMR. Methods: Cross-sectional study with N = 100 patients with GCA and/or PMR (GCA-PMR). Patient-reported outcomes (PROs) were measured using the Short Form 36 Version 2 (SF-36v2) and visual analog scale (VAS) assessment. Moreover, the Patient Health Questionnaire 9 (PHQ-9) was used in 35 of 100 patients to detect depression. To compare PROs with physician assessment, VAS was also rated from physician perspective. To assess a possible association with inflammation itself, serological parameters of inflammation (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]) were included. Results: In all scales of the SF-36v2 except General Health (GH) and in the physical and mental sum score (PCS, MCS), a significant impairment compared to the German reference collective was evident (MCS: d = 0.533, p < 0.001). In the PHQ-9 categorization, 14 of the 35 (40%) showed evidence of major depression disorder. VAS Patient correlated significantly with PHQ-9 and SF-36 in all categories, while VAS Physician showed only correlations to physical categories and not in the mental dimensions. Regarding inflammatory parameters, linear regression showed CRP to be a complementary significant positive predictor of mental health subscale score, independent of pain. Conclusion: PRO show a relevant impairment of mental health up to symptoms of major depression disorder. The degree of depressive symptoms is also distinctly associated with the serological inflammatory marker CRP.

Feasibility study of a self-guided internet-based intervention for family caregivers of patients with cancer (OAse).

Despite high levels of distress, family caregivers of patients with cancer rarely seek psychosocial support and Internet-based interventions (IBIs) are a promising approach to reduce some access barriers. Therefore, we developed a self-guided IBI for family caregivers of patients with cancer (OAse), which, in addition to patients' spouses, also addresses other family members (e.g., adult children, parents). This study aimed to determine the feasibility of OAse (recruitment, dropout, adherence, participant satisfaction). Secondary outcomes were caregivers' self-efficacy, emotional state, and supportive care needs. N = 41 family caregivers participated in the study (female: 65%), mostly spouses (71%), followed by children (20%), parents (7%), and friends (2%). Recruitment (47%), retention (68%), and adherence rates (76% completed at least 4 of 6 lessons) support the feasibility of OAse. Overall, the results showed a high degree of overall participant satisfaction (96%). There were no significant pre-post differences in secondary outcome criteria, but a trend toward improvement in managing difficult interactions/emotions (p = .06) and depression/anxiety (p = .06). Although the efficacy of the intervention remains to be investigated, our results suggest that OAse can be well implemented in caregivers' daily lives and has the potential to improve family caregivers' coping strategies.

LNA oligonucleotide mediates an anti-inflammatory effect in autoimmune myocarditis via targeting lactate dehydrogenase B.

Treatment of myocarditis is often limited to symptomatic treatment due to unknown pathomechanisms. In order to identify new therapeutic approaches, the contribution of locked nucleic acid antisense oligonucleotides (LNA ASOs) in autoimmune myocarditis was investigated. Hence, A/J mice were immunized with cardiac troponin I (TnI) to induce experimental autoimmune myocarditis (EAM) and treated with LNA ASOs. The results showed an unexpected anti-inflammatory effect for one administered LNA ASO MB_1114 by reducing cardiac inflammation and fibrosis. The target sequence of MB_1114 was identified as lactate dehydrogenase B (mLDHB). For further analysis, mice received mLdhb-specific GapmeR during induction of EAM. Here, mice receiving the mLdhb-specific GapmeR showed increased protein levels of cardiac mLDHB and a reduced cardiac inflammation and fibrosis. The effect of increased cardiac mLDHB protein level was associated with a downregulation of genes of reactive oxygen species (ROS)-associated proteins, indicating a reduction in ROS. Here, the suppression of murine pro-apoptotic Bcl-2-associated X protein (mBax) was also observed. In our study, an unexpected anti-inflammatory effect of LNA ASO MB_1114 and mLdhb-specific GapmeR during induction of EAM could be demonstrated in vivo. This effect was associated with increased protein levels of cardiac mLDHB, mBax suppression and reduced ROS activation. Thus, LDHB and LNA ASOs may be considered as a promising target for directed therapy of myocarditis. Nevertheless, further investigations are necessary to clarify the mechanism of action of anti-inflammatory LDHB-triggered effects.

The influence of motivation and emotion on sensorimotor rhythm-based brain-computer interface performance.

While decades of research have investigated and technically improved brain-computer interface (BCI)-controlled applications, relatively little is known about the psychological aspects of brain-computer interfacing. In 35 healthy students, we investigated whether extrinsic motivation manipulated via monetary reward and emotional state manipulated via video and music would influence behavioral and psychophysiological measures of performance with a sensorimotor rhythm (SMR)-based BCI. We found increased task-related brain activity in extrinsically motivated (rewarded) as compared with nonmotivated participants but no clear effect of emotional state manipulation. Our experiment investigated the short-term effect of motivation and emotion manipulation in a group of young healthy subjects, and thus, the significance for patients in the locked-in state, who may be in need of a BCI, remains to be investigated.

Wheelchair Control in a Virtual Environment by Healthy Participants Using a P300-BCI Based on Tactile Stimulation: Training Effects and Usability.

Tactile stimulation is less frequently used than visual for brain-computer interface (BCI) control, partly because of limitations in speed and accuracy. Non-visual BCI paradigms, however, may be required for patients who struggle with vision dependent BCIs because of a loss of gaze control. With the present study, we attempted to replicate earlier results by Herweg et al. (2016), with several minor adjustments and a focus on training effects and usability. We invited 16 healthy participants and trained them with a 4-class tactile P300-based BCI in five sessions. Their main task was to navigate a virtual wheelchair through a 3D apartment using the BCI. We found significant training effects on information transfer rate (ITR), which increased from a mean of 3.10-9.50 bits/min. Further, both online and offline accuracies significantly increased with training from 65% to 86% and 70% to 95%, respectively. We found only a descriptive increase of P300 amplitudes at Fz and Cz with training. Furthermore, we report subjective data from questionnaires, which indicated a relatively high workload and moderate to high satisfaction. Although our participants have not achieved the same high performance as in the Herweg et al. (2016) study, we provide evidence for training effects on performance with a tactile BCI and confirm the feasibility of the paradigm.

30+ years of P300 brain-computer interfaces.

Brain-computer interfaces (BCIs) directly measure brain activity with no physical movement and translate the neural signals into messages. BCIs that employ the P300 event-related brain potential often have used the visual modality. The end user is presented with flashing stimuli that indicate selections for communication, control, or both. Counting each flash that corresponds to a specific target selection while ignoring other flashes will elicit P300s to only the target selection. P300 BCIs also have been implemented using auditory or tactile stimuli. P300 BCIs have been used with a variety of applications for severely disabled end users in their homes without frequent expert support. P300 BCI research and development has made substantial progress, but challenges remain before these tools can become practical devices for impaired patients and perhaps healthy people.

Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist).

Neurofeedback has begun to attract the attention and scrutiny of the scientific and medical mainstream. Here, neurofeedback researchers present a consensus-derived checklist that aims to improve the reporting and experimental design standards in the field.

Hearing the needs of clinical users.

In the past 10 years, brain-computer interfaces (BCIs) for controlling assistive devices have seen tremendous progress with respect to reliability and learnability, and numerous exemplary applications were demonstrated to be controllable by a BCI. Yet, BCI-controlled applications are hardly used for patients with neurologic or neurodegenerative disease. Such patient groups are considered potential end-users of BCI, specifically for replacing or improving lost function. We argue that BCI research and development still faces a translational gap, i.e., the knowledge of how to bring BCIs from the laboratory to the field is insufficient. BCI-controlled applications lack usability and accessibility; both constitute two sides of one coin, which is the key to use in daily life and to prevent nonuse. To increase usability, we suggest rigorously adopting the user-centered design in applied BCI research and development. To provide accessibility, assistive technology (AT) experts, providers, and other stakeholders have to be included in the user-centered process. BCI experts have to ensure the transfer of knowledge to AT professionals, and listen to the needs of primary, secondary, and tertiary end-users of BCI technology. Addressing both, usability and accessibility, in applied BCI research and development will bridge the translational gap and ensure that the needs of clinical end-users are heard, understood, addressed, and fulfilled.

External Validity of the Multicomponent Group Treatment KiSS for School-Aged Children With Insomnia.

Background: Insomnia is common in school-aged children and often associated with other mental disorders. Here, we investigated the effectiveness and acceptance of the KiSS program in an "all-comer" pediatric insomnia clinic. Participants/Methods: Forty-five families (children: 5-10 years, 57.8% female) were randomly assigned to the multicomponent six-session KiSS treatment (CBT-I, hypnotherapy, and imaginations) or a wait-list control group. A sleep diary was recorded before intervention or waiting time, immediately after, as well as 3, 6, and 12 months postintervention (primary outcome: sleep efficiency, SE; sleep-onset latency, SOL). Results: Sleep improved significantly after the KiSS intervention. Three to 12 months after the intervention, only 1.75% of treated children still met the diagnostic criteria for insomnia. SE improved to 96%, and both SOL (reduced to 23 min) and total sleep time were normalized. All improvements were stable for at least one year after the intervention. KiSS was well accepted (0% dropout during intervention) and well tolerated. Conclusions: Treatment with the multimodal sleep training KiSS leads to positive changes in the sleep of children with insomnia, including a subset of children that presented with comorbid mental disorders. With only three sessions for parents and three sessions for children, the treatment can be readily implemented as a stand-alone treatment or be combined with other interventions. Dismantling studies and studies with an active control group are ongoing.

Mental imagery for brain-computer interface control and communication in non-responsive individuals.

BACKGROUND: People who survive severe brain damage may eventually develop a prolonged consciousness disorder. Others can regain full consciousness but remain unable to speak or move because of the severity of the lesions, as for those with locked-in syndrome (LIS). Brain-computer interface techniques can be useful to disentangle these states by detecting neurophysiological correlates of conscious processing of information to enable communication with these individuals after the diagnosis. OBJECTIVE: The goal of our study was to evaluate with a user-centered design approach the usability of a mental imagery task to detect signs of voluntary information processing and enabling communication in a group of severely disabled individuals. METHODS: Five individuals with LIS participated in the study. Participants were instructed to imagine hand, arm or feet movements during electroencephalography (EEG) to detect patterns of event-related synchronization/desynchronization associated with each task. After the user-centered design, usability was evaluated (i.e., efficiency, effectiveness and satisfaction). RESULTS: Two participants achieved significant levels of accuracy in 2 different tasks. The associated workload and levels of satisfaction perceived by the users were moderate and were mainly related to the time demand of the task. CONCLUSION: Results showed lack of effectiveness of the task to detect voluntary brain activity and thus detect consciousness or communicate with non-responsive individuals. The application must be modified to be sufficiently satisfying for the intended end-users and suggestions are made in this regard.

A comparison of implicit and explicit reward learning in low risk alcohol users versus people who binge drink and people with alcohol dependence.

Chronic alcohol use leads to specific neurobiological alterations in the dopaminergic brain reward system, which probably are leading to a reward deficiency syndrome in alcohol dependence. The purpose of our study was to examine the effects of such hypothesized neurobiological alterations on the behavioral level, and more precisely on the implicit and explicit reward learning. Alcohol users were classified as dependent drinkers (using the DSM-IV criteria), binge drinkers (using criteria of the USA National Institute on Alcohol Abuse and Alcoholism) or low-risk drinkers (following recommendations of the Scientific board of trustees of the German Health Ministry). The final sample (n = 94) consisted of 36 low-risk alcohol users, 37 binge drinkers and 21 abstinent alcohol dependent patients. Participants were administered a probabilistic implicit reward learning task and an explicit reward- and punishment-based trial-and-error-learning task. Alcohol dependent patients showed a lower performance in implicit and explicit reward learning than low risk drinkers. Binge drinkers learned less than low-risk drinkers in the implicit learning task. The results support the assumption that binge drinking and alcohol dependence are related to a chronic reward deficit. Binge drinking accompanied by implicit reward learning deficits could increase the risk for the development of an alcohol dependence.

Ethical Principles in Patient-Centered Medical Care to Support Quality of Life in Amyotrophic Lateral Sclerosis.

It is one of the primary goals of medical care to secure good quality of life (QoL) while prolonging survival. This is a major challenge in severe medical conditions with a prognosis such as amyotrophic lateral sclerosis (ALS). Further, the definition of QoL and the question whether survival in this severe condition is compatible with a good QoL is a matter of subjective and culture-specific debate. Some people without neurodegenerative conditions believe that physical decline is incompatible with satisfactory QoL. Current data provide extensive evidence that psychosocial adaptation in ALS is possible, indicated by a satisfactory QoL. Thus, there is no fatalistic link of loss of QoL when physical health declines. There are intrinsic and extrinsic factors that have been shown to successfully facilitate and secure QoL in ALS which will be reviewed in the following article following the four ethical principles (1) Beneficence, (2) Non-maleficence, (3) Autonomy and (4) Justice, which are regarded as key elements of patient centered medical care according to Beauchamp and Childress. This is a JPND-funded work to summarize findings of the project NEEDSinALS (www.NEEDSinALS.com) which highlights subjective perspectives and preferences in medical decision making in ALS.

Neural mechanisms of training an auditory event-related potential task in a brain-computer interface context.

Effective use of brain-computer interfaces (BCIs) typically requires training. Improved understanding of the neural mechanisms underlying BCI training will facilitate optimisation of BCIs. The current study examined the neural mechanisms related to training for electroencephalography (EEG)-based communication with an auditory event-related potential (ERP) BCI. Neural mechanisms of training in 10 healthy volunteers were assessed with functional magnetic resonance imaging (fMRI) during an auditory ERP-based BCI task before (t1) and after (t5) three ERP-BCI training sessions outside the fMRI scanner (t2, t3, and t4). Attended stimuli were contrasted with ignored stimuli in the first-level fMRI data analysis (t1 and t5); the training effect was verified using the EEG data (t2-t4); and brain activation was contrasted before and after training in the second-level fMRI data analysis (t1 vs. t5). Training increased the communication speed from 2.9 bits/min (t2) to 4 bits/min (t4). Strong activation was found in the putamen, supplementary motor area (SMA), and superior temporal gyrus (STG) associated with attention to the stimuli. Training led to decreased activation in the superior frontal gyrus and stronger haemodynamic rebound in the STG and supramarginal gyrus. The neural mechanisms of ERP-BCI training indicate improved stimulus perception and reduced mental workload. The ERP task used in the current study showed overlapping activations with a motor imagery based BCI task from a previous study on the neural mechanisms of BCI training in the SMA and putamen. This suggests commonalities between the neural mechanisms of training for both BCI paradigms.

Psychological Predictors of Visual and Auditory P300 Brain-Computer Interface Performance.

Brain-Computer Interfaces (BCIs) provide communication channels independent from muscular control. In the current study we used two versions of the P300-BCI: one based on visual the other on auditory stimulation. Up to now, data on the impact of psychological variables on P300-BCI control are scarce. Hence, our goal was to identify new predictors with a comprehensive psychological test-battery. A total of N = 40 healthy BCI novices took part in a visual and an auditory BCI session. Psychological variables were measured with an electronic test-battery including clinical, personality, and performance tests. The personality factor "emotional stability" was negatively correlated (Spearman's rho = -0.416; p < 0.01) and an output variable of the non-verbal learning test (NVLT), which can be interpreted as ability to learn, correlated positively (Spearman's rho = 0.412; p < 0.01) with visual P300-BCI performance. In a linear regression analysis both independent variables explained 24% of the variance. "Emotional stability" was also negatively related to auditory P300-BCI performance (Spearman's rho = -0.377; p < 0.05), but failed significance in the regression analysis. Psychological parameters seem to play a moderate role in visual P300-BCI performance. "Emotional stability" was identified as a new predictor, indicating that BCI users who characterize themselves as calm and rational showed worse BCI performance. The positive relation of the ability to learn and BCI performance corroborates the notion that also for P300 based BCIs learning may constitute an important factor. Further studies are needed to consolidate or reject the presented predictors.

A Multifunctional Brain-Computer Interface Intended for Home Use: An Evaluation with Healthy Participants and Potential End Users with Dry and Gel-Based Electrodes.

Current brain-computer interface (BCIs) software is often tailored to the needs of scientists and technicians and therefore complex to allow for versatile use. To facilitate home use of BCIs a multifunctional P300 BCI with a graphical user interface intended for non-expert set-up and control was designed and implemented. The system includes applications for spelling, web access, entertainment, artistic expression and environmental control. In addition to new software, it also includes new hardware for the recording of electroencephalogram (EEG) signals. The EEG system consists of a small and wireless amplifier attached to a cap that can be equipped with gel-based or dry contact electrodes. The system was systematically evaluated with a healthy sample, and targeted end users of BCI technology, i.e., people with a varying degree of motor impairment tested the BCI in a series of individual case studies. Usability was assessed in terms of effectiveness, efficiency and satisfaction. Feedback of users was gathered with structured questionnaires. Two groups of healthy participants completed an experimental protocol with the gel-based and the dry contact electrodes (N = 10 each). The results demonstrated that all healthy participants gained control over the system and achieved satisfactory to high accuracies with both gel-based and dry electrodes (average error rates of 6 and 13%). Average satisfaction ratings were high, but certain aspects of the system such as the wearing comfort of the dry electrodes and design of the cap, and speed (in both groups) were criticized by some participants. Six potential end users tested the system during supervised sessions. The achieved accuracies varied greatly from no control to high control with accuracies comparable to that of healthy volunteers. Satisfaction ratings of the two end-users that gained control of the system were lower as compared to healthy participants. The advantages and disadvantages of the BCI and its applications are discussed and suggestions are presented for improvements to pave the way for user friendly BCIs intended to be used as assistive technology by persons with severe paralysis.

A Pilot Study on the Effects of Slow Paced Breathing on Current Food Craving.

Heart rate variability biofeedback (HRV-BF) involves slow paced breathing (approximately six breaths per minute), thereby maximizing low-frequent heart rate oscillations and baroreflex gain. Mounting evidence suggests that HRV-BF promotes symptom reductions in a variety of physical and mental disorders. It may also positively affect eating behavior by reducing food cravings. The aim of the current study was to investigate if slow paced breathing can be useful for attenuating momentary food craving. Female students performed paced breathing either at six breaths per minute (n = 32) or at nine breaths per minute (n = 33) while watching their favorite food on the computer screen. Current food craving decreased during a first resting period, increased during paced breathing, and decreased during a second resting period in both conditions. Although current hunger increased in both conditions during paced breathing as well, it remained elevated after the second resting period in the nine breaths condition only. Thus, breathing rate did not influence specific food craving, but slow paced breathing appeared to have a delayed influence on state hunger. Future avenues are suggested for the study of HRV-BF in the context of eating behavior.

Basic discriminative and semantic processing in patients in the vegetative and minimally conscious state.

Patients who survive injuries to the brain following accidents or diseases often acquire a disorder of consciousness (DOC). Assessment of the state of consciousness in these patients is difficult since they are usually incapable of reproducible motor movements. The application of event-related potentials (ERP) recorded via EEG constitutes one promising approach to complement the assessment of cognitive functions in DOC patients. For these assessments, a hierarchical approach was suggested which means that paradigms aiming at higher order ERPs are only presented if early responses were found. In this study, 19 behaviorally unresponsive or low-responsive DOC patients were presented with three auditory paradigms using passive instructions. The paradigms aimed at eliciting the Mismatch Negativity (MMN) and N400 and were applied at two time points. One oddball paradigm (MMN) and two semantic paradigms (word-pairs: N400 Words; sentences: N400 Sentences) were included. The majority of patients (n=15) did not show any response to the stimulation. In the MMN paradigm, an MMN was identified in two patients, in the N400 Words paradigm, only an N1 was identified in one patient, and in the N400 Sentences paradigm, a late positive complex (LPC) was identified in two patients. These data contradict the hierarchical approach since the LPC was identified in patients who did not exhibit an MMN. They further support the notion that even higher information processing as addressed with the N400 paradigms is preserved in a minority of DOC patients. Thus, in this sample, around 10% of the DOC patients exhibited indicators of preserved consciousness.