情绪能力自助应用程序与认知行为自助应用程序和自我监控应用程序对比,以预防风险较高的年轻人患抑郁症(ECoWeB PREVENT):一项国际、多中心、平行、开放标签、随机对照试验。

IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Lancet Digital Health Pub Date : 2024-10-04 DOI:10.1016/S2589-7500(24)00148-1
Edward R Watkins, Fiona C Warren, Alexandra Newbold, Claire Hulme, Timothy Cranston, Benjamin Aas, Holly Bear, Cristina Botella, Felix Burkhardt, Thomas Ehring, Mina Fazel, Johnny R J Fontaine, Mads Frost, Azucena Garcia-Palacios, Ellen Greimel, Christiane Hößle, Arpine Hovasapian, Veerle E I Huyghe, Kostas Karpouzis, Johanna Löchner, Guadalupe Molinari, Reinhard Pekrun, Belinda Platt, Tabea Rosenkranz, Klaus R Scherer, Katja Schlegel, Bjorn W Schuller, Gerd Schulte-Korne, Carlos Suso-Ribera, Varinka Voigt, Maria Voß, Rod S Taylor
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Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. 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引用次数: 0

摘要

背景:需要有效的、可扩展的干预措施来预防青少年的不良心理健康。虽然心理健康应用程序可以提供可扩展的预防措施,但很少有应用程序在建立在健康情绪功能模型基础上或根据个人情况量身定制的高功率试验中接受过严格测试。我们的目标是测试个性化情绪能力应用程序与认知行为疗法(CBT)自助应用程序和自我监控应用程序的对比,以防止青少年抑郁症状的增加:这项多中心、平行、开放标签、随机对照试验是在英国、德国、西班牙和比利时的四个大学试验点进行的,属于队列多重随机试验(包括一项促进健康的平行试验)的一部分。参与者分别从四个国家的学校、大学和社交媒体招募。符合条件的参与者年龄在 16-22 岁之间,根据基线情绪能力档案,他们的脆弱性有所提高,但目前或过去未被诊断出患有重度抑郁症。参与者通过一个独立的计算机系统被随机分配(1:1:1)到常规实践加个性化情绪能力自助应用程序、通用 CBT 自助应用程序或自我监控应用程序中,最小化国家、年龄和自我报告的性别,并在随机分配后随访 12 个月。结果评估人员对组别分配进行了屏蔽。主要结果是随访3个月时的抑郁症状(根据患者健康问卷-9 [PHQ-9]),对完成3个月随访评估的参与者进行分析。该研究已在 ClinicalTrials.gov 注册,编号为 NCT04148508,现已结束:2020年10月15日至2021年8月3日期间,共有1262名参与者注册,其中417人使用情绪能力应用程序,423人使用CBT应用程序,422人使用自我监控应用程序。平均年龄为 18-8 岁(SD 2-0)。在 1262 名自我报告性别的参与者中,984 人(78-0%)为女性,253 人(20-0%)为男性,15 人(1-2%)两者都不是,10 人(0-8%)两者都是。情绪能力应用程序组的 178 名参与者、CBT 应用程序组的 191 名参与者和自我监控应用程序组的 199 名参与者完成了 3 个月的跟踪评估。3 个月时,CBT 应用程序的抑郁症状低于自我监控应用程序(PHQ-9 的平均差异为 -1-18 [95% CI -2-01 to -0-34];p=0-006),但情绪能力应用程序与 CBT 应用程序(0-63 [-0-22 to 1-49];p=0-15)或自我监控应用程序与情绪能力应用程序(-0-54 [-1-39 to 0-31];p=0-21)之间的抑郁症状没有差异。在完成任何一项后续评估的 541 名参与者中,有 31 人接受了住院治疗,或因与干预无关的精神健康相关原因入院治疗(情绪能力应用程序组 8 人,CBT 应用程序组 15 人,自我监控应用程序组 8 人)。没有人死亡:与自我监控应用程序相比,CBT 应用程序延迟了高危青少年抑郁症状的增加,尽管这种益处在 12 个月后逐渐消失。与假设相反,情绪能力应用程序在减少抑郁症状方面并不比自我监控应用程序更有效。鉴于CBT自助应用程序的可扩展性、非消耗性和可负担性,它可能是针对年轻人的有价值的公共心理健康干预措施:欧盟委员会。
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Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial.

Background: Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people.

Methods: This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed.

Findings: Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths occurred.

Interpretation: The CBT app delayed increases in depression symptoms in at-risk young people relative to the self-monitoring app, although this benefit faded by 12 months. Against hypotheses, the emotional competence app was not more effective at reducing depression symptoms than the self-monitoring app. CBT self-help apps might be valuable public mental health interventions for young people given their scalability, non-consumable nature, and affordability.

Funding: European Commission.

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来源期刊
CiteScore
41.20
自引率
1.60%
发文量
232
审稿时长
13 weeks
期刊介绍: The Lancet Digital Health publishes important, innovative, and practice-changing research on any topic connected with digital technology in clinical medicine, public health, and global health. The journal’s open access content crosses subject boundaries, building bridges between health professionals and researchers.By bringing together the most important advances in this multidisciplinary field,The Lancet Digital Health is the most prominent publishing venue in digital health. We publish a range of content types including Articles,Review, Comment, and Correspondence, contributing to promoting digital technologies in health practice worldwide.
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