Department for Psychosomatic Medicine and Psychotherapy, LVR-University Hospital Essen, University of Duisburg-Essen, Essen, Nordrhein-Westfalen, Germany
Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University of Duisburg-Essen, Essen, Germany.
BMJ Open. 2024 Apr 17;14(4):e079098. doi: 10.1136/bmjopen-2023-079098.
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.
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.
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.
Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.
脑电图神经反馈（NFB）作为一种非侵入性的脑波训练形式，已被证明在治疗各种心理健康障碍方面有效。然而，只有少数关于规范化和标准化 NFB 训练的结果存在。这使得研究的比较和复制变得困难。因此，我们为在身心科门诊就诊的心理健康障碍患者开发了 NFB 训练的标准手册。目前的研究旨在调查在心理健康障碍患者中进行标准化 NFB 训练手册的实施情况。如果成功，该研究将为在临床实践中以更具控制性和可比性的方式研究 NFB 提供新的机会。
将纳入 30 名被诊断为心理健康障碍的患者。在教育访谈后，患者将进行基线诊断（T0）。随后的干预包括 10 次 NFB 训练，旨在增加感觉运动节律和 alpha 频率幅度，降低 theta 频率和高 beta 频率幅度，以诱导放松并降低主观压力。所有患者将在治疗后进行诊断评估（T1），并在疗程结束后 8 周进行随访评估（T2）。在预评估、后评估和随访评估以及 NFB 疗程中，将通过脑电图记录振幅带的变化（主要结果）。在 T0、T1 和 T2 时评估生理（呼吸率、血容量脉搏、肌肉张力）和心理计量学参数（痛苦、感知压力、放松能力、抑郁和焦虑症状、失眠、自我效能和生活质量）。此外，在 NFB 训练后 T1 时评估满意度、接受度和可用性。此外，在研究开始后 6 个月，对 NFB 从业者进行关于干预体验的定性访谈。使用重复测量方差分析以及混合线性模型的中介分析来分析定量数据。使用 Mayring 的内容分析来分析定性数据。
该研究已获得杜伊斯堡-埃森大学医学系伦理委员会的批准（23-11140-BO），并于 2023 年 4 月开始招募患者。在参与之前，将要求每位参与者书面同意。研究结果将发表在同行评议的期刊和会议演讲中。
2023 年 3 月 28 日在德国临床试验注册中心前瞻性注册，DRKS00031497。
