Outcomes of a public health campaign and automated randomised controlled trial of a direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study). (Preprint)
Authors: Morriss Richard , Kaylor-Hughes Catherine , Rawsthorne Matthew , Coulson Neil , Simpson Sandra , Guo Boliang , James Marilyn , Lathe James , Moran Paul , Tata Laila , Williams Laura 
Published: August 2020

BACKGROUND

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 public health online services delivered directly to the public. One model is Big White Wall, which offers peer support at low cost. Since these interventions are delivered digitally, we tested whether a randomised controlled trial (RCT) intervention could also be fully delivered and evaluated digitally.

OBJECTIVE

To determine the reach, feasibility, acceptability, baseline costs and outcomes of a public health campaign for an automated randomised controlled trial of Big White Wall (BWW) providing digital peer support and information, compared with a standard website used by the National Health Service (NHS Choices Moodzone, MZ) in people with probable mild to moderate depression and anxiety disorder. The primary outcome was change in self-rated well-being at 6 weeks, measured by the Warwick-Edinburgh Mental Well-Being Scale.

METHODS

An 18 month campaign was performed across Nottinghamshire, United Kingdom (target population 914,000) to advertise the trial direct to the public through general marketing, online and social media sources, health services, other public services and third sector groups. The population reach of this campaign was examined by numbers accessing the study website and self-registering to the study. A pragmatic, parallel group, single blind RCT (ISRCTN ) was then conducted using a fully automated trial website in which eligible participants were randomised to receive either 6 months access to BWW or signposted to MZ. Those eligible for participation were over 16 years with probable mild to moderate depression or anxiety disorders.

RESULTS

Of 6483 visitors to the study website, only 1,510 were eligible. 790 (52.3% of eligible) participated, 397 randomised to BWW and 393 to MZ. Their mean age (sd) was 38.0 (13.8) years, 640 (82.0%) were female, 738 (93.7%) were white, all had educational qualifications, and 271 (47.4%) had no contact with health services in the previous three months. We estimated 3-month productivity losses of £1019.05 (1057.70) per person for those employed. Only 131 (16.6%) participants completed the primary outcome assessment. There were no differences in primary nor secondary outcomes between the two groups.

CONCLUSIONS

Most participants reached and eligible for this trial of digital intervention providing information and/or support for mild to moderate depression and anxiety were educated women of white ethnicity 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.

CLINICALTRIAL

International Standard Randomized Controlled Trial Number (ISRCTN) 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428.

INTERNATIONAL REGISTERED REPORT

RR2-10.2196/resprot.8061