DYD-RCT: On-line randomised controlled trial of an interactive web-based intervention for reducing alcohol consumption

We are investigating whether a website (Down Your Drink) can help heavy drinkers drink less alcohol. It is estimated that around 7.1 million people in England aged 16 - 64 (26% of the population) are drinking over the recommended safe levels. Although treatments do exist, there are many people in need of treatment that do not have access to it.

Some studies have found the use of websites for people with long-term conditions (such as heart disease) to be associated with improved knowledge, confidence, social support, health behaviours and clinical outcomes. Internet interventions are popular with users, as they are convenient (can be used at any time of day or night), accessible (can be used by anyone with Internet access), anonymous and confidential. They can be revisited as often as wanted, which may help to change behaviour and prevent relapse.

We have updated the existing Down Your Drink website inline with user feedback and research findings on user requirements of Internet interventions. To find out what features of Down Your Drink are responsible for changing behaviour, if any, our participants have access to different areas of the website. We hope to make Down Your Drink freely available in December 2009.

Excess alcohol consumption is a major public health problem with around one quarter of the UK population at risk of harm from excess alcohol. Brief interventions are known to be effective in reducing alcohol consumption, but often fail to reach those at risk. A pilot study found that an on-line intervention could reduce alcohol consumption in heavy drinkers. The aim of the study is to determine whether the fully interactive on-line intervention DYD: www.downyourdrink.org.uk leads to important reductions in alcohol consumption amongst members of the public at risk of harm from alcohol. The comparator for the study will be the minimially interactive website HYD: www.howsyourdrink.org.uk which will provide information only. The trial will be conducted entirely on-line, including registration, screening, recruitment, randomisation and baseline and follow-up assessments. This will be a 3.5-year complex intervention study, incorporating a Phase 2 development stage taking 15 months (optimization of intervention, on-line trial materials, and overall trial design, together with a pilot phase to determine the likely rates of recruitment and compliance), and a Phase 3 two-arm randomized controlled trial conducted on-line, with recruitment over 12 months and follow-up for 12 months. Stop-go criteria will be used for decisions regarding progression from Phase 2 to Phase 3. Trial closure, analysis and publication will take a further 3 months.