Background: Effective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. One model, the Big White Wall (BWW), offers peer support at low cost. As these interventions are delivered digitally, we tested whether a randomized controlled trial (RCT) intervention could also be fully delivered and evaluated digitally. Objective: This study aims to determine the reach, feasibility, acceptability, baseline costs, and outcomes of a public health campaign for an automated RCT of the BWW, providing digital peer support and information, compared with a standard website used by the National Health Service Moodzone (MZ), to people with probable mild-to-moderate depression and anxiety disorder. The primary outcome was the change in self-rated well-being at 6 weeks, measured using the Warwick-Edinburgh Mental Well-Being Scale. Methods: An 18-month campaign was conducted across Nottinghamshire, the United Kingdom (target population 914,000) to advertise the trial directly to the public through general marketing, web-based and social media sources, health services, other public services, and third-sector groups. The population reach of this campaign was examined by the number of people accessing the study website and self-registering to the study. A pragmatic, parallel-group, single-blind RCT was then conducted using a fully automated trial website in which eligible participants were randomized to receive either 6 months of access to BWW or signposted to MZ. Those eligible for participation were aged >16 years with probable mild-to-moderate depression or anxiety disorders. Results: Of 6483 visitors to the study website, 1510 (23.29%) were eligible. Overall, 790 of 1510 (52.32%) visitors participated. Of 790 visitors, 397 (50.3%) were randomized to BWW and 393 (49.7%) to MZ. Their mean age was 38 (SD 13.8) years, 81.0% (640/790) were female, 93.4% (738/790) were White, and 47.4% (271/572) had no contact with health services in the previous 3 months. We estimated 3-month productivity losses of £1001.01 (95% CI 868.75-1133.27; US $1380.79; 95% CI 1198.35-1563.23) per person for those employed. Only 16.6% (131/790) participants completed the primary outcome assessment. There were no differences in the primary or secondary outcomes between the 2 groups. Conclusions: Most participants reached and those eligible for this trial of digital interventions were White women not in recent contact with health services and whose productivity losses represent a significant annual societal burden. A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention, primarily because it did not personally engage participants and explain how these unfamiliar interventions might benefit them. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 12673428; https://www.isrctn.com/ISRCTN12673428

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中文翻译：

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直接面向公众的同伴支持计划（大白墙）与基于网络的信息，以帮助抑郁和焦虑的自我管理：自动随机对照试验的结果和挑战

背景：对抑郁和焦虑的有效帮助惠及一小部分可能从中受益的人。问题的规模表明需要直接向公众提供有效、安全的基于网络的公共卫生服务。一种模型，即大白墙 (BWW)，以低成本提供对等支持。由于这些干预措施是以数字方式提供的，我们测试了随机对照试验 (RCT) 干预是否也可以完全以数字方式提供和评估。目的：本研究旨在确定 BWW 自动化 RCT 的公共卫生运动的范围、可行性、可接受性、基线成本和结果，提供数字同行支持和信息，与国家卫生服务局使用的标准网站进行比较心情区 (MZ), 对于可能患有轻度至中度抑郁症和焦虑症的人。主要结果是使用 Warwick-Edinburgh 心理健康量表测量的 6 周时自评幸福感的变化。方法：在英国诺丁汉郡（目标人口 914,000）开展了为期 18 个月的活动，通过一般营销、基于网络和社交媒体资源、卫生服务、其他公共服务和第三方直接向公众宣传试验。部门组。通过访问研究网站和自行注册研究的人数来检查该活动的人口覆盖面。然后使用完全自动化的试验网站进行务实的、平行组、单盲 RCT，其中符合条件的参与者随机接受 6 个月的 BWW 访问或 MZ 路标。符合参与条件的人年龄 > 16 岁，可能患有轻度至中度抑郁症或焦虑症。结果：在研究网站的 6483 名访问者中，1510 名（23.29%）符合条件。总体而言，1510 名参观者中有 790 人（52.32%）参加了此次活动。在 790 名访客中，397 名 (50.3%) 被随机分配到 BWW，393 名 (49.7%) 被随机分配到 MZ。他们的平均年龄为 38 (SD 13.8) 岁，81.0% (640/790) 为女性，93.4% (738/790) 为白人，47.4% (271/572) 在过去 3 个月内未接触过医疗服务. 我们估计在职人员每人 3 个月的生产力损失为 1001.01 英镑（95% CI 868.75-1133.27；1380.79 美元；95% CI 1198.35-1563.23）。只有 16.6% (131/790) 的参与者完成了主要结果评估。两组的主要或次要结局无差异。结论：大多数参与者和那些有资格参加这项数字干预试验的人是最近没有接触过卫生服务的白人女性，她们的生产力损失代表了重大的年度社会负担。直接从公众招募的全自动 RCT 未能招募和留住足够的参与者来测试这种数字干预的临床有效性，主要是因为它没有亲自参与参与者并解释这些不熟悉的干预如何使他们受益。试验注册：国际标准随机对照试验编号（ISRCTN）12673428；https://www.isrctn.com/ISRCTN12673428 直接从公众招募的全自动 RCT 未能招募和留住足够的参与者来测试这种数字干预的临床有效性，主要是因为它没有亲自参与参与者并解释这些不熟悉的干预如何使他们受益。试验注册：国际标准随机对照试验编号（ISRCTN）12673428；https://www.isrctn.com/ISRCTN12673428 直接从公众招募的全自动 RCT 未能招募和留住足够的参与者来测试这种数字干预的临床有效性，主要是因为它没有亲自参与参与者并解释这些不熟悉的干预如何使他们受益。试验注册：国际标准随机对照试验编号（ISRCTN）12673428；https://www.isrctn.com/ISRCTN12673428

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