Supplementary Material for: Internet-Delivered Disease Management for Recurrent Depression: A Multicenter Randomized Controlled Trial

Background: Strategies to improve the life of patients suffering from recurrent major depression have a high relevance. This study examined the efficacy of 2 Internet-delivered augmentation strategies that aim to prolong symptom-free intervals. Methods: Efficacy was tested in a 3-arm, multicenter, open-label, evaluator-blind, randomized controlled trial. Upon discharge from inpatient mental health care, 232 adults with 3 or more major depressive episodes were randomized to 1 of 2 intervention groups (SUMMIT or SUMMIT-PERSON) or to treatment as usual (TAU) alone. Over 12 months, participants in both intervention arms received, in addition to TAU, intense monitoring via e-mail or a smartphone, including signaling of upcoming crises, assistance with personal crisis management, and facilitation of early intervention. SUMMIT-PERSON additionally offered regular expert chats. The primary outcome was ‘well weeks', i.e. weeks with at most mild symptoms assessed by the Longitudinal Interval Follow-Up Evaluation, during 24 months after the index treatment. Results: SUMMIT compared to TAU reduced the time with an unwell status (OR 0.48; 95% CI 0.23-0.98) through faster transitions from unwell to well (OR 1.44; 95% CI 0.83-2.50) and slower transitions from well to unwell (OR 0.69; 95% CI 0.44-1.09). Contrary to the hypothesis, SUMMIT-PERSON was not superior to either SUMMIT (OR 0.77; 95% CI 0.38-1.56) or TAU (OR 0.62; 95% CI 0.31-1.24). The efficacy of SUMMIT was strongest 8 months after the intervention. Conclusions: The fully automated Internet-delivered augmentation strategy SUMMIT has the potential to improve TAU by reducing the lifelong burden of patients with recurrent depression. The fact that the effects wear off suggests a time-unlimited extension.

背景：改善复发性重度抑郁症患者生存质量的相关策略具有重要临床意义。本研究旨在评估两种旨在延长无症状间歇期的互联网辅助干预策略的疗效。

方法：本研究采用三臂、多中心、开放标签、评价者设盲的随机对照试验，对干预疗效进行验证。研究纳入232名曾罹患3次及以上重度抑郁发作的成年患者，在其精神科住院治疗出院后，将其随机分配至两个干预组（SUMMIT或SUMMIT-PERSON）或仅接受常规治疗（treatment as usual, TAU）组。在12个月的随访周期内，两个干预组受试者除接受TAU外，还将通过电子邮件或智能手机接受强化监测服务，内容包括危机预警、个人危机管理协助以及早期干预的引导；其中SUMMIT-PERSON组额外提供定期专家咨询服务。本研究的主要结局指标为无症状周（well weeks），即经纵向间歇随访评估（Longitudinal Interval Follow-Up Evaluation）判定为症状至多为轻度的周数，观察周期为本次指数治疗后的24个月。

结果：相较于TAU组，SUMMIT组通过加快从症状发作到症状缓解的转换速度（比值比OR=1.44；95%置信区间CI=0.83~2.50）、减慢从症状缓解到症状发作的转换速度（OR=0.69；95%CI=0.44~1.09），缩短了患者的症状持续时长（OR=0.48；95%CI=0.23~0.98）。与研究假设相悖的是，SUMMIT-PERSON组的疗效并未优于SUMMIT组（OR=0.77；95%CI=0.38~1.56）或TAU组（OR=0.62；95%CI=0.31~1.24）。此外，SUMMIT组的干预疗效在干预后8个月时最为显著。

结论：全自动化的互联网辅助干预策略SUMMIT有望通过降低复发性抑郁症患者的终身疾病负担，优化常规治疗方案的临床效果。鉴于其疗效会随时间衰减，提示可开展无时限的干预方案延伸。