Effectiveness of app-based cognitive behavioral therapy for insomnia on preventing major depressive disorder in youth with insomnia and subclinical depression: A randomized clinical trial.

IF 15.8 1区 医学 Q1 Medicine
PLoS Medicine Pub Date : 2025-01-21 eCollection Date: 2025-01-01 DOI:10.1371/journal.pmed.1004510
Si-Jing Chen, Jian-Yu Que, Ngan Yin Chan, Le Shi, Shirley Xin Li, Joey Wing Yan Chan, Weizhen Huang, Chris Xie Chen, Chi Ching Tsang, Yuen Lam Ho, Charles M Morin, Ji-Hui Zhang, Lin Lu, Yun Kwok Wing
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引用次数: 0

Abstract

Background: Increasing evidence suggests that insomnia plays an important role in the development of depression, supporting insomnia intervention as a promising approach to prevent depression in youth. This randomized controlled trial evaluated the effectiveness of app-based cognitive behavioral therapy for insomnia (CBT-I) in preventing future onset of major depressive disorder (MDD) in youth.

Methods and findings: This was a randomized, assessor-blind, parallel group-controlled trial in Chinese youth (aged 15-25 years) with insomnia disorder and subclinical depressive symptoms. Participants were randomly assigned (1:1) to 6-week app-based CBT-I or 6-week app-based health education (HE) delivered through smartphones. Online assessments and telephone clinical interviews were conducted at baseline, post-intervention, 6- and 12-month follow-ups. The primary outcome was time to onset of MDD. The secondary outcomes included depressive symptoms and insomnia at both symptom and disorder levels. Between September 9, 2019, and November 25, 2022, 708 participants (407 females [57%]; mean age, 22.1 years [SD = 1.9]) were randomly allocated to app-based CBT-I group (n = 354) or app-based HE group (n = 354). Thirty-seven participants (10%) in the intervention group and 62 participants (18%) in the control group developed new-onset MDD throughout the 12-month follow-up, with a hazard ratio of 0.58 (95% confidence interval 0.38-0.87; p = 0.008). The number needed to treat to prevent MDD at 1 year was 10.9 (6.8-26.6). The app-based CBT-I group has higher remission rates of insomnia disorder than the controls at post-intervention (52% versus 28%; relative risk 1.83 [1.49-2.24]; p < 0.001) and throughout 12-month follow-up. In addition, the CBT-I group reported a greater decrease in depressive (adjusted difference -1.0 [-1.6 to -0.5]; Cohen's d = 0.53; p < 0.001) and insomnia symptoms (-2.0 [-2.7 to -1.3], d = 0.78; p < 0.001) than the controls at post-intervention and throughout 6-month follow-up. Insomnia was a mediator of intervention effects on depression. No adverse events related to the interventions were reported.

Conclusions: App-based CBT-I is effective in preventing future onset of major depression and improving insomnia outcomes among youth with insomnia and subclinical depression. These findings highlight the importance of targeting insomnia to prevent the onset of MDD and emphasize the need for wider dissemination of digital CBT-I to promote sleep and mental health in the youth population.

Trial registration: ClinicalTrials.Gov (NCT04069247).

基于app的认知行为治疗失眠症对青少年重度抑郁症伴失眠和亚临床抑郁症的预防效果:一项随机临床试验
背景:越来越多的证据表明,失眠在抑郁症的发展中起着重要作用,支持失眠干预是预防青少年抑郁症的一种有希望的方法。这项随机对照试验评估了基于app的失眠认知行为疗法(CBT-I)在预防青少年未来发生重度抑郁症(MDD)方面的有效性。方法和发现:这是一项随机、评估盲、平行组对照试验,研究对象为患有失眠障碍和亚临床抑郁症状的中国青年(15-25岁)。参与者被随机(1:1)分配到6周基于应用程序的CBT-I或6周通过智能手机提供的基于应用程序的健康教育(HE)。在基线、干预后、6个月和12个月随访时进行在线评估和电话临床访谈。主要结果是到重度抑郁症发病的时间。次要结局包括抑郁症状和失眠的症状和障碍水平。2019年9月9日至2022年11月25日期间,708名参与者(407名女性[57%];平均年龄22.1岁[SD = 1.9]),随机分为基于app的CBT-I组(n = 354)和基于app的HE组(n = 354)。在12个月的随访中,干预组37名(10%)参与者和对照组62名(18%)参与者出现了新发重度抑郁症,风险比为0.58(95%可信区间0.38-0.87;P = 0.008)。1年内需要治疗以预防重度抑郁症的人数为10.9(6.8-26.6)。在干预后,基于应用程序的CBT-I组失眠的缓解率高于对照组(52%对28%;相对危险度1.83 [1.49-2.24];P < 0.001)和12个月的随访。此外,CBT-I组抑郁症的下降幅度更大(调整差值为-1.0[-1.6至-0.5];Cohen’s d = 0.53;P < 0.001)和失眠症状(-2.0[-2.7至-1.3],d = 0.78;P < 0.001),在干预后和6个月的随访中均高于对照组。失眠是抑郁症干预效果的中介。没有与干预措施相关的不良事件报告。结论:基于app的CBT-I可有效预防青少年失眠症合并亚临床抑郁症患者的重性抑郁未来发作,改善失眠症结局。这些发现强调了以失眠为目标预防重度抑郁症发作的重要性,并强调了更广泛地传播数字CBT-I以促进青少年人群的睡眠和心理健康的必要性。试验注册:临床试验。政府(NCT04069247)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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