Needs and Demands for e-Health Interventions in Patients Attending a Psychosomatic Outpatient Clinic: A Baseline Assessment for a User-Centered Design Approach.

Objective: Increased utilization of e-health services can help to meet shortages of psychotherapeutic treatment. e-Health interventions can be effective if tailored according to the individual needs and demands of the target group. To gather comprehensive data for the development of a user-centered e-health intervention, a cross-sectional study was conducted among a heterogeneous cohort of 309 patients seeking treatment or consultation at psychosomatic university hospital in a densely populated region of Germany. Methods: Sociodemographic data, psychometric dimensions of mental burden, as well as needs and demands regarding an e-health intervention were assessed. A descriptive statistical analysis and a cluster analysis were performed to examine distribution of preferences and differences based on level of burden regarding needs and demands for e-health interventions. Results: Two hundred thirty-nine (N = 239) participants were included in the final data analysis. Among this primarily urban target group smartphone availability was favored by 77.8% of the participants. The cluster analysis revealed significant differences dependent on mental burden. 75.2% of participants with a high mental burden preferred longer interventions of 1-4 months compared with 49% in the low burden group, which also considered short interventions of up to 1 month (46%). Differences were also identified for content preferences and daily-life integration and were consistent irrespective of the initial reason for consultation. Conclusion: The findings of this study can provide a foundational framework for developing user-centered psychosomatic interventions. The potential relationship between individual burden and individual needs and demands highlights the crucial role of preliminary research to tailor interventions to effectively address diverse needs and preferences.

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.