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Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.
BMC Psychiatry ( IF 4.4 ) Pub Date : 2020-09-22 , DOI: 10.1186/s12888-020-02857-w
A Newbold 1 , F C Warren 2 , R S Taylor 2, 3 , C Hulme 2 , S Burnett 1 , B Aas 4 , C Botella 5, 6 , F Burkhardt 7 , T Ehring 8 , J R J Fontaine 9 , M Frost 10 , A Garcia-Palacios 5, 6 , E Greimel 4 , C Hoessle 8 , A Hovasapian 9 , Vei Huyghe 9 , J Lochner 4, 8 , G Molinari 6 , R Pekrun 11 , B Platt 4 , T Rosenkranz 8 , K R Scherer 12 , K Schlegel 13 , G Schulte-Korne 4 , C Suso 5 , V Voigt 4 , E R Watkins 1
Affiliation  

Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles. The Emotional Competence for Well-Being in Young Adults cohort multiple randomised controlled trial (cmRCT) involves a longitudinal prospective cohort to examine well-being, mental health and EC in 16–22 year olds across 12 months. Within the cohort, eligible participants are entered to either the PREVENT trial (if selected EC scores at baseline within worst-performing quartile) or to the PROMOTE trial (if selected EC scores not within worst-performing quartile). In both trials, participants are randomised (i) to continue with usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app. In total, 2142 participants aged 16 to 22 years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium. Assessments take place at baseline (pre-randomisation), 1, 3 and 12 months post-randomisation. Primary endpoint and outcome for PREVENT is level of depression symptoms on the Patient Health Questionnaire-9 at 3 months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale at 3 months. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored. The trial aims to provide a better understanding of the causal role of learning EC skills using interventions delivered via mobile phone apps with respect to promoting well-being and preventing poor mental health in young people. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective Mobile-health public health strategies for preventing poor mental health and promoting well-being. ClinicalTrials.gov ( www.clinicaltrials.org ). Number of identification: NCT04148508 November 2019.

中文翻译:

通过手机应用程序促进年轻人的心理健康:ECoWeB的研究方案(年轻人的幸福感的能力)可进行多项随机试验。

促进青年人的福祉和预防其不良的心理健康是全球主要的优先事项。通过移动应用程序建立情感能力(EC)技能可能是一种有效,可扩展且可接受的方法。但是,很少有大型对照试验检查过移动应用程序在促进年轻人心理健康方面的功效;没有人根据个人资料定制该应用程序。青年人情绪健康能力队列多项随机对照试验(cmRCT)涉及一项纵向前瞻性队列研究,以检查整个12个月内16-22岁儿童的健康,心理健康和EC。在同类群组中 符合条件的参与者将参加PREVENT试验(如果在基线时表现最差的四分位数中选择了EC分数)或PROMOTE试验(如果选择的EC分数不在表现最差的四分位数中)。在这两个试验中,参与者均被随机分组​​(i)继续常规练习,重复评估和自我监控应用程序;(ii)在应用中另外获得通用的认知行为治疗自助服务;(iii)在应用程序中另外获得个性化EC自助服务。总共将招募2142名年龄在16至22岁之间,没有当前或过去有严重抑郁,双相情感障碍或精神病史的参与者,他们遍布英国,德国,西班牙和比利时。评估在基线(随机前),随机后1、3和12个月进行。PREVENT的主要终点和结局是3个月患者健康问卷9上的抑郁症状水平;促进的主要终点和结果是根据Warwick-Edinburgh心理健康量表在3个月时评估的情绪健康。抑郁症状,焦虑,福祉,与健康相关的生活质量,功能和成本效益是次要结果。合规性,不良事件和潜在的中介变量将受到仔细监控。该试验旨在通过手机应用程序提供的干预措施,更好地了解学习EC技能的因果作用,以促进年轻人的幸福感和预防不良的心理健康。这些知识将用于开发和传播创新的,基于证据的,可行的,有效的流动健康公共卫生策略,以防止精神健康不良和促进幸福感。ClinicalTrials.gov(www.clinicaltrials.org)。识别号:NCT04148508 2019年11月。
更新日期:2020-09-22
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