具有和没有文本的重复性跨脑磁性刺激4 支持治疗抗性抑郁症:以患者为中心的多中心随机控制试验试验协议
Medard Kofi Adu1, Raquel da Luz Dias1, Belinda Agyapong2
1Department of Psychiatry, Dalhousie University, Halifax, NS, Canada.
JMIR research protocols
|December 7, 2023
概括
这项研究调查了添加Text4Support到重复性跨磁刺激 (rTMS) 中是否可以改善治疗耐药性抑郁症 (TRD) 的结果. 研究人员假设,结合疗法将与单独使用rTMS相比,产生更好的结果.
科学领域:
- 神经科学是一个神经科学.
- 精神病学是一个精神病学.
- 数字健康数字健康
背景情况:
- 耐治疗抑郁症 (TRD) 缺乏缓解与标准抗抑郁药试验.
- 重复性跨磁刺激 (rTMS) 和像Text4Support这样的数字治疗是新兴的策略.
- 目前尚不清楚RTMS和Text4Support对TRD的联合疗效.
研究的目的:
- 为了比较rTMS的临床有效性与没有Text4Support的TRD管理.
- 评估一个创新的,以患者为中心的干预TRD.
主要方法:
- 一个多中心的,双臂的,评估者盲目的随机控制的试点试验.
- 200名TRD参与者被随机分配到单独rTMS或rTMS加Text4Support.
- 主要结局:患者健康问卷-9 (PHQ-9) 在6个月内得分的变化.
主要成果:
- 研究结果预计将在招募后18个月.
- 假设:rTMS加上Text4Support将显示优越的结果与单独的rTMS相比.
- 二次结果包括通用焦虑障碍 (GAD-7) 和自杀严重程度等级.
结论:
- 这是第一次研究rTMS和Text4Support的组合.
- 该试验旨在提供关于这种新型综合治疗方法的实际应用和疗效的基础数据.
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