Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial

Background: 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, anonymised public health driven online services such as Big White Wall which offers immediate peer support at low cost. The primary aim of the study is to determine the effectiveness of randomisation to Big White Wall (BWW) compared to online information compiled by the UK’s National Health Service (NHS Choices Moodzone) in people with mild to moderate depression and anxiety. The secondary aims are to determine cost effectiveness, the population reach of this service and adoption by services.

Method/Design: A pragmatic, parallel group, single blind RCT is being conducted using a fully automated trial website in which eligible participants are randomised 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, healthcare staff, large employers and third sector groups. People will refer themselves to the study and will eligible if they are over 16 years, have mild to moderate depression or anxiety and have access to the internet. The primary outcome will be mental well-being at six weeks. We will also explore secondary end points in terms of cost effectiveness from a health and social perspective. In addition, the reach and adoption of BWW will be recorded and possible mechanisms of action will be explored.

Discussion: This will be the first fully digital trial of a direct to public peer support programme 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 randomised controlled trial of two digital interventions using a fully automated digital enrolment and data collection process are considered for people with depression and anxiety.