Massey Heather, Denton Hannah, Burlingham Amy, Violato Mara, Bibby-Jones Anna-Marie, Cunningham Rebecca, Ciccognani Sandy, Robertson Sam, Strauss Clara
Extreme Environments Laboratory, School of Sport, Health and Exercise Sciences, University of Portsmouth, Spinnaker Building, Portsmouth, PO1 2ER, UK.
R&D Department, Sussex Education Centre, Sussex Partnership NHS Foundation Trust, Nevill Avenue, Brighton & Hove, BN3 7HZ, UK.
Pilot Feasibility Stud. 2023 Jul 13;9(1):122. doi: 10.1186/s40814-023-01358-3.
Depression 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/DESIGN: To 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.
If 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.
Current controlled trial registration number is ISRCTN 90851983 registered on 19 May 2022.
抑郁症很常见,且在全球范围内患病率不断上升;至少每10人中就有1人在其一生中会经历抑郁症。它在个人、医疗保健和社会层面都与经济成本相关。推荐的治疗方法包括药物治疗和心理治疗。然而,鉴于等待时间长,且有时对这些治疗的依从性和参与度不佳,需要更多样化的方法。有证据表明户外游泳作为一种支持抑郁症康复的干预措施具有潜力,但缺乏评估其临床和成本效益的随机对照试验(RCT)。本研究旨在调查开展一项确定性优效性RCT的可行性,该试验将比较在常规护理基础上增加一个为期8节的户外游泳课程与仅接受常规护理,针对有轻度至中度抑郁症症状的成年人。可行性问题将考察招募和保留率、随机化和测量方法的可接受性,并确定将为确定性全面RCT的样本量计算提供依据的主要结局指标。本研究还将通过评估问卷、焦点小组讨论和访谈来探索参与的潜在促进因素和障碍。
方法/设计:为实现这些目标,将开展一项1:1分配的可行性优效性RCT。我们将通过社会处方组织和社交媒体在英格兰的三个地点招募88名有轻度至中度抑郁症症状的参与者。参与者将被随机分为两组:(1)干预组(为期8节的户外游泳课程)加常规护理或(2)仅接受常规护理。两组都将再随访8周。
如果这项可行性RCT的结果是有利的,将开展一项有充分效力的RCT来调查该干预措施的临床和成本效益。确定性试验的结果将为政策制定者提供关于户外游泳治疗抑郁症的证据,并有可能为有抑郁症症状的成年人带来更多的干预选择。
当前对照试验注册号为ISRCTN 90851983,于2022年5月19日注册。