Kaylor-Hughes Catherine J, Rawsthorne Mat, Coulson Neil S, Simpson Sandra, Simons Lucy, Guo Boliang, James Marilyn, Moran Paul, Simpson Jayne, Hollis Chris, Avery Anthony J, Tata Laila J, Williams Laura, Morriss Richard K
National Institute for Health Research: Collaboration for Leadership in Applied Health Research and Care East Midlands, University of Nottingham, Nottingham, United Kingdom.
Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
JMIR Res Protoc. 2017 Dec 18;6(12):e231. doi: 10.2196/resprot.8061.
Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health-driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost.
Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK's National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder.
A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet.
The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods.
This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety.
International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a).
无论地理位置或收入情况如何，针对抑郁症和焦虑症的有效帮助仅惠及了一小部分可能从中受益的人群。问题的规模表明，诸如大白墙（BWW）这类有效、安全且匿名的以公共卫生为导向的网络服务可以发挥作用，它们能以低成本提供即时的同伴支持。
运用“覆盖、效果、采用、实施和维持”（RE-AIM）方法，本研究旨在确定与英国国家医疗服务体系（NHS，NHS选择情绪区）编制的网络信息相比，BWW在可能患有轻度至中度抑郁症和焦虑症的人群中的覆盖范围、效果、成本效益以及实施的障碍和驱动因素。
正在使用一个全自动试验网站进行一项实用的平行组单盲随机对照试验（RCT），符合条件的参与者被随机分配，要么获得6个月的BWW访问权限，要么被引导至NHS情绪区网站。一项涉及大众营销和社交媒体、基层医疗临床倡导者、医护人员、大型雇主和第三部门团体的公共卫生参与活动将助力招募2200人参与该研究。人们可自行报名参加研究，年龄超过16岁、可能患有轻度至中度抑郁症或焦虑症且能上网者符合条件。
主要结局指标将是6周时的沃里克 - 爱丁堡心理健康量表。我们还将运用一系列定性和定量方法，探究覆盖范围、维持情况、成本效益、实施的障碍和驱动因素以及可能的作用机制。
这将是首个针对常见精神障碍的直接面向公众的在线同伴支持项目的全数字化试验。对于患有抑郁症和焦虑症的人群，考虑了将其添加到当前NHS心理健康服务中的潜在优势，以及使用全自动数字注册和数据收集流程设计一项公共卫生活动和两项数字干预措施的随机对照试验所面临的挑战。
国际标准随机对照试验编号（ISRCTN）：12673428；http://www.controlled-trials.com/ISRCTN12673428/12673428（由WebCite存档于http://www.webcitation.org/6uw6ZJk5a）
