Protocol for a pragmatic randomised controlled trial to evaluate effects of a brief intervention for emergency department attendees who present with moderate or high levels of non-specific psychological distress : A pilot study

Background: Screening and brief intervention in the emergency department (ED) has almost exclusively focused on individuals with alcohol-use problems. The early detection of mental health problems before problems become severe will enable early intervention and support which may improve health and prevent further deterioration. The main aim of this pilot study is to provide evidence of the acceptance of a telephone intervention aimed at ED attendees with moderate or high psychological distress. This will be determined by recruitment rates, retention rates and participant satisfaction with the intervention. Secondary outcomes include whether socio-demographic variables have an impact on retention rates, and whether the intervention had any impact on psychological distress. Methods/Design This study will be a single-site pragmatic randomised controlled pilot study. Consenting ED attendees will be screened with the Kessler Psychological Distress Scales (K10). There will be three arms to the study: a moderate/high psychological distress group with or without intervention, and a low psychological distress group. Those with severe psychological distress will be excluded. All included participants will be followed-up at 1, 3, 6 and 12 months post-recruitment. Retention rates will be determined by successful completion of surveys at the follow-up time-points. Psychological distress will be measured by the K10 at all follow-up time-points. Discussion This study will provide information regarding the potential for screening and recruitment at an opportunistic hospital presentation. It will provide data for a future larger study with regard to participants accepting to be included in this study. Participant acceptability will be measured in terms of recruitment rates and retention rates measured by successful follow-ups over the following 12 months post-recruitment. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12614000031662. Registered 10/01/2014.