AIMS Anxiety, depression, and reduced quality of life (QoL) are common in patients with implantable cardioverter-defibrillators (ICDs). Treatment options are limited and insufficiently defined. We evaluated the efficacy of a web-based intervention (WBI) vs. usual care (UC) for improving psychosocial well-being in ICD patients with elevated psychosocial distress. METHODS AND RESULTS This multicentre, randomized controlled trial (RCT) enrolled 118 ICD patients with increased anxiety or depression [≥6 points on either subscale of the Hospital Anxiety and Depression Scale (HADS)] or reduced QoL [≤16 points on the Satisfaction with Life Scale (SWLS)] from seven German sites (mean age 58.8 ± 11.3 years, 22% women). The primary outcome was a composite assessing change in heart-focused fear, depression, and mental QoL 6 weeks after randomization to WBI or UC, stratified for age, gender, and indication for ICD placement. Web-based intervention consisted of 6 weeks' access to a structured interactive web-based programme (group format) including self-help interventions based on cognitive behaviour therapy, a virtual self-help group, and on-demand support from a trained psychologist. Linear mixed-effects models analyses showed that the primary outcome was similar between groups (ηp2 = 0.001). Web-based intervention was superior to UC in change from pre-intervention to 6 weeks (overprotective support; P = 0.004, ηp2 = 0.036), pre-intervention to 1 year (depression, P = 0.004, ηp2 = 0.032; self-management, P = 0.03, ηp2 = 0.015; overprotective support; P = 0.02, ηp2 = 0.031), and 6 weeks to 1 year (depression, P = 0.02, ηp2 = 0.026; anxiety, P = 0.03, ηp2 = 0.022; mobilization of social support, P = 0.047, ηp2 = 0.018). CONCLUSION Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.

中文翻译：

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基于网络的干预对改善植入式心脏复律除颤器患者社会心理健康的效果：随机对照 ICD-FORUM 试验

AIMS 焦虑、抑郁和生活质量下降 (QoL) 在植入式心脏复律除颤器 (ICD) 患者中很常见。治疗选择有限且定义不充分。我们评估了基于网络的干预 (WBI) 与常规护理 (UC) 对改善社会心理压力升高的 ICD 患者的社会心理健康的效果。方Life Scale (SWLS)] 来自七个德国站点（平均年龄 58.8 ± 11.3 岁，22% 女性）。主要结果是综合评估以心脏为中心的恐惧、抑郁、随机分配至 WBI 或 UC 后 6 周的心理生活质量和心理生活质量，根据年龄、性别和 ICD 放置指征进行分层。基于网络的干预包括 6 周访问结构化的基于网络的交互式程序（小组形式），包括基于认知行为疗法的自助干预、虚拟自助小组和训练有素的心理学家的按需支持。线性混合效应模型分析表明，各组之间的主要结果相似（ηp2 = 0.001）。基于网络的干预在干预前至 6 周（过度保护支持；P = 0.004，ηp2 = 0.036）、干预前至 1 年（抑郁，P = 0.004，ηp2 = 0.032；自我管理）的变化方面优于 UC ，P = 0.03，ηp2 = 0.015；过度保护支持；P = 0.02，ηp2 = 0.031）和 6 周至 1 年（抑郁，P = 0.02，ηp2 = 0.026；焦虑，P = 0。03, ηp2 = 0.022; 动员社会支持，P = 0.047，ηp2 = 0.018）。结论 虽然主要结果是中性的，但这是第一个显示 WBI 可以改善 ICD 患者的社会心理健康的 RCT。