OUTdoor Swimming as a nature-based Intervention for DEpression (OUTSIDE): study protocol for a feasibility randomised control trial comparing an outdoor swimming intervention to usual care for adults experiencing mild to moderate symptoms of depression

BackgroundDepression is common and the prevalence increasing worldwide; at least 1 in 10 people will experience depression in their lifetime. It is associated with economic costs at the individual, healthcare and societal level. Recommended treatments include medication and psychological therapies. However, given the long waiting times, and sometimes poor concordance and engagement with these treatments, a greater range of approaches are needed. Evidence for the potential of outdoor swimming as an intervention to support recovery from depression is emerging, but randomised controlled trials (RCTs) evaluating clinical and cost-effectiveness are lacking. This study seeks to investigate the feasibility of conducting a definitive superiority RCT, comparing an 8-session outdoor swimming course offered in addition to usual care compared to usual care only, in adults who are experiencing mild to moderate symptoms of depression. Feasibility questions will examine recruitment and retention rates, acceptability of randomisation and measures, and identify the primary outcome measure that will inform the sample size calculation for a definitive full-scale RCT. This study will also explore potential facilitators and barriers of participation through evaluation questionnaires, focus-group discussions and interviews.Methods/designTo address these aims and objectives, a feasibility superiority RCT with 1:1 allocation will be undertaken. We will recruit 88 participants with mild to moderate symptoms of depression through social prescribing organisations and social media in three sites in England. Participants will be randomised to either (1) intervention (8-session outdoor swimming course) plus usual care or (2) usual care only. Both groups will be followed up for a further 8 weeks.DiscussionIf findings from this feasibility RCT are favourable, a fully powered RCT will be conducted to investigate the clinical- and cost-effectiveness of the intervention. Findings from the definitive trial will provide evidence about outdoor swimming for depression for policymakers and has the potential to lead to greater choice of interventions for adults experiencing symptoms of depression.

Automated summary

This study aims to investigate the feasibility of conducting a randomized controlled trial (RCT) to evaluate the clinical and cost-effectiveness of outdoor swimming as an intervention for depression. It will recruit 88 adults with mild to moderate symptoms of depression and randomize them into two groups: one receiving an 8-session outdoor swimming course in addition to usual care, and the other receiving usual care only. The study will assess recruitment and retention rates, acceptability of randomization and measures, and identify the primary outcome measure for a definitive RCT.