Howlett N, Bottoms L, Chater A, Clark A B, Clarke T, David L, Irvine K, Jones A, Jones J, Mengoni S E, Murdoch J, Pond M, Sharma S, Sims E J, Turner D A, Wellsted D, Wilson J, Wyatt S, Trivedi D
Department of Psychology, Sport, and Geography, University of Hertfordshire, College Lane, Hatfield, Herts, AL10 9AB, UK.
Institute for Sport and Physical Activity Research (ISPAR), School of Sport Science and Physical Activity, Faculty of Health, Education, Sport and Social Science, University of Bedfordshire, Polhill Avenue, Bedford, MK41 9EA, UK.
Pilot Feasibility Stud. 2021 Jan 4;7(1):6. doi: 10.1186/s40814-020-00734-7.
Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery.
The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13-17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a 'healthy living' behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness.
UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression.
ISRCTN, ISRCTN66452702 . Registered 9 April 2020.
年轻人中抑郁症的患病率正在上升，因此需要开发和评估行为干预措施，这些措施可能带来等同于或优于谈话疗法或药物疗法的益处。运动可能对患有抑郁症的年轻人有益，但缺乏关于有效性和运动强度影响的有力的大规模试验。本研究旨在通过确定是否有可能招募和留住年轻人、按计划开发和实施干预措施以及评估培训和实施情况，来测试针对患有抑郁症的年轻人的干预措施的随机对照试验（RCT）是否可行。
该设计为一项带有嵌入式过程评估的三臂整群随机对照可行性试验。参与者将是年龄在13至17岁、有轻度至中度情绪低落或抑郁症且正在寻求帮助的年轻人，他们来自英格兰的三个县。干预措施将由注册运动专业人员在心理健康支持人员的支持下实施，每周两次，共12周。三个组分别为高强度运动组、低强度运动组和社交活动对照组。所有组在每次运动课程之前都会接受一次“健康生活”行为改变课程，并且两个运动组的能量消耗相当。观察指标包括转诊率、招募率和保留率；运动课程的出勤率；运动课程期间达到强度的依从性和能力；缺失数据的比例；不良事件，所有这些指标均在基线、3个月和6个月时进行测量；资源使用情况；以及覆盖范围和代表性。
英国国家医疗服务体系（NHS）的政策是向年轻人提供关于通过运动帮助治疗抑郁症的建议，但目前尚无基于证据的运动干预措施来补充药物治疗或谈话疗法，或作为其替代方案。英国国家卫生与临床优化研究所（NICE）指南表明运动可以是一种有效的治疗方法，但证据基础相对薄弱。这项可行性试验将提供证据，证明招募和留住年轻人参加全面的RCT以评估运动干预对抑郁症的有效性和成本效益是否可行。
ISRCTN，ISRCTN66452702。于2020年4月9日注册。
