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创伤后应激障碍患者神经反馈自我调节训练的有效性、成本效益及安全性:一项随机对照试验

Effectiveness, Cost-Utility, and Safety of Neurofeedback Self-Regulating Training in Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial.

作者信息

Leem Jungtae, Cheong Moon Joo, Lee Hyeryun, Cho Eun, Lee So Young, Kim Geun-Woo, Kang Hyung Won

机构信息

Research Center of Traditional Korean Medicine, Wonkwang University, 460, Iksan-daero, Sin-dong, Iksan 54538, Jeollabuk-do, Korea.

Jangheung Integrative Medical Hospital, Wonkwang University, 121, Rohaseu-ro, Anyang-myeon, Jangheung-gun 59338, Jeollanam-do, Korea.

出版信息

Healthcare (Basel). 2021 Oct 11;9(10):1351. doi: 10.3390/healthcare9101351.

Abstract

Post-traumatic stress disorder (PTSD) is characterized by neurophysiological and psycho-emotional problems after exposure to trauma. Several pharmacological and psychotherapy limitations, such as adverse events and low adherence, increase the need for alternative therapeutic options. Neurofeedback is widely used for PTSD management. However, evidence of its clinical efficacy is lacking. We conducted a randomized, waitlist-controlled, assessor-blinded clinical trial to assess the effectiveness, cost-utility, and safety of 16 sessions of neurofeedback on people with PTSD for eight weeks. Eleven participants were allocated to each group. One and two subjects dropped out from the neurofeedback and control groups, respectively. The primary outcome was PTSD symptom change evaluated using the PTSD Checklist-5 (PCL-5-K). The PCL-5-K levels improved more in the neurofeedback group (44.3 ± 10.8 to 19.4 ± 7.75) than in the control group (35.1 ± 18.5 to 31.0 ± 14.92). The change value was significantly improved in the neurofeedback group (24.90 ± 13.13 vs. 4.11 ± 9.03). Secondary outcomes such as anxiety, depression, insomnia, and quality of life were also improved. In an economic analysis using EuroQol-5D, the incremental cost-per-quality-adjusted life-year was approximately $15,600, indicating acceptable cost-utility. There were no adverse events in either group. In conclusion, neurofeedback might be a useful, cost-effective, and safe intervention for PTSD management.

摘要

创伤后应激障碍(PTSD)的特征是在遭受创伤后出现神经生理和心理情绪问题。一些药物治疗和心理治疗存在局限性,如不良事件和依从性低,这增加了对替代治疗选择的需求。神经反馈被广泛用于PTSD的管理。然而,其临床疗效的证据尚缺。我们进行了一项随机、等待列表对照、评估者盲法的临床试验,以评估16节神经反馈治疗对PTSD患者进行为期八周治疗的有效性、成本效益和安全性。每组分配11名参与者。神经反馈组和对照组分别有1名和2名受试者退出。主要结局是使用创伤后应激障碍检查表-5(PCL-5-K)评估的PTSD症状变化。神经反馈组的PCL-5-K水平改善程度(从44.3±10.8降至19.4±7.75)高于对照组(从35.1±18.5降至31.0±14.92)。神经反馈组的变化值显著改善(24.90±13.13对4.11±9.03)。焦虑、抑郁、失眠和生活质量等次要结局也得到改善。在使用欧洲五维健康量表(EuroQol-5D)进行的经济分析中,增量成本效益比约为15,600美元,表明成本效益可接受。两组均未出现不良事件。总之,神经反馈可能是一种用于PTSD管理的有用、具有成本效益且安全的干预措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd46/8544423/be5156e972a7/healthcare-09-01351-g001.jpg

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