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近5年，数字疗法在失眠管理中的临床证据、患者依从性以及研究空白（研究机会）。
在过去的五年中，数字疗法（DTx）在失眠管理方面展现出显著的临床证据，其在改善睡眠结果方面的有效性得到了广泛支持。然而，患者依从性仍然是一个挑战，同时存在一些研究空白，为未来的研究提供了机会。
临床证据
数字疗法，特别是数字认知行为疗法（dCBT-I），已被证明在治疗失眠方面是有效且可及的解决方案。以下是近五年来的主要临床证据：
1. 显著的疗效：
- Insomnia Severity Index (ISI) 改善： 一项伞形回顾和元元分析（涵盖28项系统评价和荟萃分析，涉及118,970名参与者）发现，数字疗法显著改善了失眠症状（SMD = -0.42, p < 0.01），并且在随访期间效果更好（SMD = -0.69, p < 0.01）。另一项针对八种精神障碍的荟萃分析发现，数字干预对失眠有很大的效果（效应值 = 0.94）。
- 睡眠效率 (SE) 和睡眠潜伏期 (SOL) 改善： 一项结合两项多中心、双盲、安慰剂对照随机对照试验的分析显示，dCBT-I组在睡眠效率方面显著提高了7.69%，睡眠潜伏期缩短了16.77分钟，并且关于睡眠的非理性信念也显著降低。另一项研究中，WELT-I（一种基于dCBT-I的数字疗法）显著改善了睡眠效率（最小二乘差=8.28；P=.04）和与睡眠相关的非理性态度。
- 对特定人群的有效性：
- 倒班工作护士： 针对患有倒班工作睡眠障碍的护士进行的随机对照试验表明，数字SleepCare干预显著降低了失眠严重程度，在干预后和随访期均表现出更大的改善（d = 1.11 和 d = 0.97），并观察到发际皮质醇水平的降低。
- 武装部队和退伍军人： 一项系统回顾和荟萃分析发现，dCBT-I在减轻武装部队人员的失眠严重程度方面是有效的，尽管研究数量有限，但效果呈中到大程度，并且治疗效果可持续长达12个月。
- 老年人： 数字治疗模式有望增加老年人获得循证行为疗法的机会，解决失眠诊断和治疗的障碍。
- 亚阈值抑郁症患者： 一项针对社区成人亚阈值抑郁症患者的随机对照试验表明，实施五种CBT技能（包括失眠行为疗法）的智能手机CBT应用，其效果优于对照组，效应值介于-0.67至-0.16之间。
- 长期效果： 研究表明dCBT-I具有较大的短期效果和较小的长期效果，最长可达治疗后1.5年，且效果延伸至一系列心理健康因素。
2. 与传统疗法的比较：
- 与安慰剂应用比较： 多项研究表明，dCBT-I组的治疗结果优于使用安慰剂应用的对照组。
- 与药物比较： 一项探索性随机对照试验正在评估数字CBT应用（IIIP MED: Sleepy Med）与唑吡坦（一种常用安眠药）在治疗失眠症患者方面的有效性和安全性。
- 成本效益： 在韩国，一项成本效益分析发现，从卫生系统角度来看，通过Somzz进行的数字CBT与常规治疗相比，虽然成本略高，但健康结果有所改善，且ICER远低于韩国的支付意愿阈值。从社会角度来看，数字CBT具有成本节约效益，因为它减少了医疗利用、工作场所事故和生产力损失。日本也批准了针对失眠管理的SUSMED MedCBT-i数字疗法，并在随机对照试验中显示出显著改善。
3. 辅助治疗效果：
- 治疗师指导： 在治疗师指导下，数字疗法对失眠产生了更积极的影响（SMD = -1.05, p < 0.01）。对患者的定性研究表明，治疗师的支持对于坚持iCBT至关重要，具体体现在增强个人自主性、巩固治疗联盟以及协助情绪调节方面。
- 文化适应： 针对非西方、受教育、工业化、富裕、民主（non-WEIRD）人群，全面且参与式的文化适应与数字心理健康干预（DMHI）的参与度和有效性相关。结合文化调整和人工支持的研究报告了最有利的参与度和临床结果。
患者依从性
尽管数字疗法在有效性方面表现出色，但患者依从性仍然是影响其广泛应用和疗效的关键因素。
1. 依从性挑战：
- 相对较高的辍学率： 尽管数字干预的总体辍学率中等（≤20%），但在干预组中通常较高。
- 与自我指导模式相关： 自我指导的iCBTs通常表现出比治疗师辅助版本更高的辍学率，这表明一定程度的治疗师参与可能对提高参与度和治疗依从性是必要的。
- 依从性与疗效的关系： 对睡眠限制疗法（SRT）的依从性越差，睡眠效率越低，夜间觉醒次数越多。针对倒班工作护士的研究也指出，对于完成干预的参与者，观察到更大的效果，这表明开发有效的策略来促进治疗依从性是必要的。
2. 促进依从性的策略：
- 治疗师支持： 患者认为治疗师支持对于iCBT的依从性至关重要，即使是简短的文本沟通也能产生有意义的影响。
- 文化适应： 深度、参与式的文化适应，如语言翻译与文化共鸣内容相结合、利益相关者参与和迭代优化，与较低的辍学率（<11%）和较高的依从性（>75%）持续相关。相比之下，表面层面的适应（例如，仅翻译）则显示出较高的辍学率（高达56%）。
- 个性化指导： 在dCBT中融入个性化指导可以进一步提高其有效性。
- 识别依从性障碍： 及时识别参与障碍的策略对于提高CBT-I的影响力至关重要。
研究空白（研究机会）
尽管数字疗法在失眠管理方面取得了显著进展，但仍有几个领域需要进一步探索和发展：
1. 疗效的进一步确认与优化：
- 对照组设置： 针对某些适应症（特别是无指导治疗），需要更多高质量的试验和与常规护理的比较，以确认效果的稳健性。例如，很少有研究将dCBT-I与安慰剂应用进行比较。未来的研究可以更多地比较数字疗法与常规CBT-I、其他数字干预或非治疗对照组，以更全面地评估其相对优势。
- 非应答者和部分应答者： 需要开发针对CBT-I非应答者和部分应答者的诊断和治疗方法。例如，接受与承诺疗法（ACT-I）被认为是CBT-I非应答者的一个有前景的治疗方法，但仍需在实际的CBT-I非应答者中进行评估。
- 优化CBT-I协议： 通过深入理解治疗机制和开发适应性治疗策略来优化当前的CBT-I协议。此外，将体育锻炼或基于昼夜节律的干预作为附加方案，可能对某些失眠患者亚组有益。
- 特定CBT技能的贡献： 需要进一步研究CBT中所有组成部分是否都有益并有助于心理健康促进，以了解CBT主动成分，从而设计更有效和可扩展的心理疗法。
- 长期效果和维持机制： 虽然现有证据表明长期效果可持续，但仍需进一步研究数字疗法在更长时间跨度内的疗效维持机制和影响因素。
2. 依从性和参与度的提升：
- 混合人-数字交付模式： 未来研究应整合混合人-数字交付模型，以提高普遍性和可扩展性。将治疗师支持与数字平台相结合，可以帮助解决自我指导方案中较高的辍学率问题。
- 客观参与度指标： 需要更客观的参与度指标，而不是仅仅依赖自我报告，以更准确地评估患者的依从性。
- 个性化和适应性干预： 开发更具个性化和适应性的数字干预，以满足不同患者的需求和偏好，这可能有助于提高依从性。人工智能技术，特别是大型语言模型（LLM），被认为是未来治疗的重要方向，能够根据患者反馈提供个性化治疗建议，从而提高治疗效果和患者参与度。
- 文化适应的进一步研究： 尽管文化适应显示出积极效果，但仍需在更广泛的国家范围内确认这些结果，并确定最可行的dCBT交付模式，特别是与农村和偏远社区居民合作。
- 患者伴侣的参与： 考虑将患者伴侣纳入治疗过程，以促进对CBT-I治疗建议的依从性。
3. 实施和可及性挑战：
- 扩大覆盖范围： 尽管数字疗法具有可扩展性，但在临床实践中实施CBT-I仍然是一个主要挑战。需要通过提供简短治疗、针对性治疗以及数字治疗来改善实施。
- 法规和支付系统： 随着数字疗法日益商业化并成为可处方数字疗法，行业参与度的增加既带来机遇也带来新挑战。需要进一步研究其长期疗效、安全性和成本效益，并建立国际协调的监管审查和授权系统，以促进患者早期获得有前景的DTx产品。
- 数字素养和可及性： 解决与数字素养和患者参与度相关的挑战，尤其是在技术普及程度不同的地区和人群中。
- 多样化人群的研究： 尽管在特定人群（如武装部队人员和倒班工作护士）中取得进展，但仍需在更广泛、更多样化的患者群体中进行大型多中心试验，以提高结果的普遍性。
4. 机制研究和预测模型：
- 治疗机制： 进一步研究数字疗法的具体治疗机制，包括哪些成分对哪些患者最有效。
- 预测依从性和疗效： 开发模型以预测哪些患者最有可能从数字疗法中受益或面临依从性挑战，从而实现更精准的干预。
- 多源数据融合与隐私保护： 随着AI驱动的CBT-I发展，需要解决多源数据融合和隐私保护问题，以促进CBT-I的创新和发展。
5. 比较不同数字疗法的效果：
- 目前已有多款针对失眠的DTx产品获得监管机构授权，但尚未有产品在多个国家获得授权，这表明需要对不同产品之间的效果进行比较研究，并推动国际法规协调。
总之，近五年的证据充分支持数字疗法在失眠管理中的有效性，尤其是在改善失眠严重程度和睡眠质量方面。然而，为了充分发挥其潜力，未来的研究应着重于提高患者依从性、优化治疗方案、扩大应用范围，并解决实施过程中的挑战，同时深入探究治疗机制和利用新兴技术（如AI）来提供更个性化和高效的干预。
References
1Digital therapeutics for insomnia: an umbrella review and meta-meta-analysis.PubMed
Can Li, Qiyun Luo, Hong Wu
The growing burden of insomnia underscores the necessity for accessible and effective treatments, with digital therapeutics offering a promising solution. A systematic search was conducted across seven databases (PubMed, Web of Science, EMBASE, MEDLINE, ProQuest, Scopus, and the Cochrane Library) covering the period from the inception of each database until October 2024. A total of 28 systematic reviews and meta-analyses evaluating digital therapeutics with reported insomnia-related outcomes were included, encompassing 118,970 participants. The primary outcome, Insomnia Severity Index (ISI), indicated that digital therapeutics significantly improved insomnia (SMD = -0.42, p < 0.01), with better results observed during follow-up (SMD = -0.69, p < 0.01). Under the guidance of therapists, digital therapeutics exerted a more positive effect (SMD = -1.05, p < 0.01). The secondary outcomes also showed consistent results, with no significant differences observed in Total Sleep Time (TST) between the post-intervention and follow-up periods. Based on the assessment results, there is sufficient evidence to recommend the use of digital therapeutics.
2Effectiveness of digital interventions for eight mental disorders: A meta-analytic synthesis.PubMed
Mathias Harrer, Clara Miguel, Lingyao Tong, et al.
OBJECTIVES: In this unified series of meta-analyses, we integrate the effects of digital interventions in adults with mental disorders compared to inactive controls. We cover eight indications: depressive disorder, insomnia, specific phobias, generalized anxiety, panic, social anxiety, obsessive-compulsive, and posttraumatic stress disorder. METHODS: Digital intervention trials in patients with a diagnosed mental disorder (confirmed by clinical interviews) were extracted from the Metapsy living databases for psychological treatments. Standardized meta-analyses were conducted to pool effects for each disorder, as well as separately for guided and unguided treatments. We also examined study dropout rates, conducted meta-regression analyses stratified by disorder, and identified treatments that have since become available as prescribable digital therapeutics in routine care. RESULTS: In total, 168 studies (22,144 patients) were included. Moderate effect sizes were observed for PTSD ( = 0.57), depression ( = 0.62), and obsessive-compulsive disorder ( = 0.68). Large effects emerged for generalized anxiety ( = 0.80), social anxiety ( = 0.84), insomnia ( = 0.94), panic disorder ( = 1.05), and specific phobias ( = 1.18). Pooled study dropout rates were generally moderate (≤20 %), but higher in intervention arms ( = 1.13-2.66). Trials with low risk of bias and care-as-usual comparisons were limited across indications. We found 16 trials evaluating a prescribable digital therapeutic ( = 0.33-1.60). CONCLUSIONS: Digital interventions can be effective across a wide range of diagnosed mental disorders. For some indications, more high-quality trials and comparisons against care-as-usual are needed to confirm the robustness of the effect, particularly for unguided treatments. Digital interventions are increasingly commercialized as prescribable digital therapeutics. Rising industry involvement may present both opportunities and new challenges for the field.
3Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness.PubMed
Suonaa Lee, Kyung Mee Park, Do Hyun Lee, et al.
PURPOSE: Although digital cognitive behavioral therapy for insomnia (dCBT-I) offers a promising solution to the accessibility limitations of traditional face-to-face CBT-I, few studies have examined dCBT-I against a sham app and adherence issues remain. This study assessed the efficacy of dCBT-I compared with a sham app and investigated whether adherence predicts sleep outcomes. MATERIALS AND METHODS: In this combined analysis of two multicenter, double-blind, sham-controlled randomized controlled trials, 120 patients with insomnia were randomized to use the dCBT-I app (n=60) or a sham app (n=60). The primary outcome was the change in sleep efficiency (SE) from baseline after the 6-week intervention. The relationship between adherence to sleep restriction therapy (SRT) and sleep outcomes post-intervention was assessed. RESULTS: After adjusting for age, sex, sleep medication use, and baseline levels of each outcome variable, the dCBT-I group demonstrated better treatment outcomes than the sham app group, with significant improvements of 7.69% in SE [95% confidence interval (CI), 3.09% to 12.30%; =0.001], -16.77 minutes in sleep onset latency (95% CI, -31.48 to -2.06 minutes; =0.026), and -0.97 in dysfunctional beliefs about sleep (95% CI, -1.46 to -0.48; <0.001) from baseline. Poorer adherence to SRT was associated with reduced SE (=0.006) and increased nighttime wakefulness (=0.002) after controlling for age, sex, years of education, and the baseline value of each outcome variable. CONCLUSION: This combined analysis demonstrates the efficacy of dCBT-I in improving sleep outcomes compared with a sham app and highlights the role of adherence to SRT in enhancing treatment efficacy. The two studies were registered with ClinicalTrials.gov (NCT05822999, NCT05809544).
4Retention and Engagement in Culturally Adapted Digital Mental Health Interventions: Systematic Review of Dropout, Attrition, and Adherence in Non-Western, Educated, Industrialized, Rich, Democratic Settings.PubMed
Tanya Tandon, Rajashree Biswas, Quentin Meteier, et al.
BACKGROUND: Digital mental health interventions (DMHIs) offer scalable and cost-effective support for mental health but are predominantly developed in WEIRD (western, educated, industrialized, rich, democratic) contexts, raising questions about their global applicability. Dropout, attrition, and adherence rates critically influence DMHI effectiveness yet remain poorly characterized in culturally adapted formats. OBJECTIVE: This systematic review aimed to (1) synthesize evidence on dropout, attrition, and adherence in culturally adapted DMHIs delivered to non-WEIRD adult populations and (2) assess the methodological quality of the included studies. METHODS: PsycINFO, PubMed, and ScienceDirect were systematically searched for randomized controlled trials published in English between January 2014 and April 2024. Screening and data extraction followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, and methodological quality was evaluated using the Appraisal Tool for Cross-Sectional Studies tool. Extracted variables included dropout, attrition, adherence, adaptation techniques, and clinical outcomes. RESULTS: Twenty-three randomized controlled trials (n=4656) from diverse regions met inclusion criteria. Attrition ranged from 5.3% to 87% (median 18.4%), dropout from 0% to 66% (median 18.7%), and adherence from 26.3% to 100% (median 71%). Deep, participatory adaptations-such as language translation combined with culturally resonant content, stakeholder engagement, and iterative refinement-were consistently associated with lower dropout (<11%) and higher adherence (>75%). In contrast, surface-level adaptations (eg, translation only) showed higher dropout (up to 56%). Studies that incorporated both cultural tailoring and human support reported the most favorable engagement and clinical outcomes (eg, reductions in insomnia, depression, and anxiety). Most studies (91%) were rated as "Good" quality, although some lacked representative sampling or objective engagement metrics. CONCLUSIONS: Comprehensive and participatory cultural adaptation is associated with engagement and effectiveness of DMHIs among non-WEIRD populations. Future research should integrate hybrid human-digital delivery models, objective engagement metrics, and larger multicenter trials to improve generalizability and scalability.
5Novel psychotherapies for insomnia.PubMed
Marie Angelillo, Jaap Lancee, Elisabeth Hertenstein
Insomnia disorder, characterized by a complaint of reduced sleep quality or quantity and associated daytime impairment, is highly prevalent and associated with reduced quality of life and productivity. Cognitive behavioural therapy for insomnia (CBT-I) is the current first-line treatment for chronic insomnia disorder. Here, we outline our perspective for the future optimization of psychotherapeutic treatment for insomnia. We identified the following areas as the most promising: first, optimizing efficacy of the CBT-I protocol; second, developing diagnostic and therapeutic approaches for non-responders and partial responders; and third, advancing widespread implementation of psychotherapy for insomnia. More specifically, we outline how the current CBT-I protocol could be optimized through an improved understanding of treatment mechanisms, and discuss the potential of adaptive treatment strategies. Another promising approach for improving the current CBT-I protocol is using add-ons such as physical exercise or circadian-based interventions. Both may be promising in certain subgroups of patients with insomnia. In terms of non-response, we identify acceptance and commitment therapy for insomnia (ACT-I) as a promising treatment for non-responders to CBT-I. ACT-I, however, still needs to be evaluated in actual non-responders to CBT-I. Implementing CBT-I in clinical practice is still one of the major challenges at hand. We outline how brief treatment, targeted treatment for challenging patient groups, and digital treatment may help improve implementation. For a future research agenda, we suggest that further research into treatment mechanisms, randomized-controlled trials in non-responders to CBT-I, and a focus on implementation science have a potential to bring the field forward.
6Digital cognitive-behavioural therapy application compared with zolpidem for the treatment of insomnia: protocol for an exploratory randomised controlled trial.PubMed
Eiji Shimizu, Daisuke Sato, Yoshiyuki Hirano, et al.
INTRODUCTION: Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) as Software as a Medical Device for insomnia. This paper describes the study protocol for an exploratory randomised controlled trial (RCT) to evaluate effectiveness and safety of our developed digital CBT (dCBT) for 5 weeks compared with zolpidem tartrate for patients with insomnia disorder. METHODS AND ANALYSIS: This proposed multicentre exploratory RCT will be conducted at the outpatient clinic of Chiba University Hospital, Akita University Hospital and Yoyogi Sleep Disorder Center, Japan. The study population comprises two parallel groups (dCBT and zolpidem) consisting of 15 participants each (n=30 in total) diagnosed with insomnia disorder who remain symptomatic at 4 weeks after sleep hygiene education. We will evaluate the effectiveness at baseline, week 5 (post-intervention) and week 10 (follow-up). The primary outcome will be the change of subjective sleep onset latency at week 5 from baseline. Secondary outcomes include sleep-related outcomes, such as objective sleep onset latency measured by mobile electroencephalography, functional improvement during the daytime and quality of life. ETHICS AND DISSEMINATION: Ethics approval was granted by the Institutional Review Board of Chiba University Hospital (K2023001). All participants will be required to provide written informed consent. Results will be published in international journals. TRIAL REGISTRATION NUMBER: jRCT2032230353.
7Computerized Cognitive Behavior Therapy for Anxiety and Depression in Rural Areas: A Systematic Review.PubMed
Kari Dee Vallury, Martin Jones, Chloe Oosterbroek
BACKGROUND: People living in rural and remote communities have greater difficulty accessing mental health services and evidence-based therapies, such as cognitive behavior therapy (CBT), than their urban counterparts. Computerized CBT (CCBT) can be used to effectively treat depression and anxiety and may be particularly useful in rural settings where there are a lack of suitably trained practitioners. OBJECTIVE: To systematically review the global evidence regarding the clinical effectiveness and acceptability of CCBT interventions for anxiety and/or depression for people living in rural and remote locations. METHODS: We searched seven online databases: Medline, Embase Classic and Embase, PsycINFO, CINAHL, Web of Science, Scopus, and the Cochrane Library. We also hand searched reference lists, Internet search engines, and trial protocols. Two stages of selection were undertaken. In the first, the three authors screened citations. Studies were retained if they reported the efficacy, effectiveness or acceptability of CCBT for depression and/or anxiety disorders, were peer reviewed, and written in English. The qualitative data analysis software, NVivo 10, was then used to run automated text searches for the word "rural," its synonyms, and stemmed words. All studies identified were read in full and were included in the study if they measured or meaningfully discussed the efficacy or acceptability of CCBT among rural participants. RESULTS: A total of 2594 studies were identified, of which 11 met the selection criteria and were included in the review. The studies that disaggregated efficacy data by location of participant reported that CCBT was equally effective for rural and urban participants. Rural location was found to both positively and negatively predict adherence across studies. CCBT may be more acceptable among rural than urban participants—studies to date showed that rural participants were less likely to want more face-to-face contact with a practitioner and found that computerized delivery addressed confidentiality concerns. CONCLUSIONS: CCBT can be effective for addressing depression and anxiety and is acceptable among rural participants. Further work is required to confirm these results across a wider range of countries, and to determine the most feasible model of CCBT delivery, in partnership with people who live and work in rural and remote communities.
8Therapists' Role in Patient Adherence to Internet-Based Cognitive Behavioral Therapy: Qualitative Study.PubMed
Henriikka Anne-Mari Seittu, Tomas Falk, Kushagra Bhatnagar, et al.
BACKGROUND: Internet-based cognitive behavioral therapies (iCBTs) are typically categorized into 2 types: therapist-assisted and self-guided. Both formats have accumulated substantial evidence supporting their cost-effectiveness and efficacy in treating a range of mental health conditions. However, therapist-assisted iCBTs tend to show lower dropout rates than self-guided versions. The relatively high dropout rates in self-guided programs suggest that some degree of therapist involvement may be necessary to improve engagement and treatment adherence. Yet, the specific reasons for therapist support in iCBT and its functions in improving engagement and treatment adherence remain an underexplored area of research. OBJECTIVE: This study aimed to explore patients' experiences with therapist-assisted iCBT to identify the elements they perceive as important for treatment adherence and to clarify the role of therapist support in the iCBT process. METHODS: This study draws on 89 semistructured in-depth interviews with iCBT users. Patients took part in 9 different therapist-assisted iCBT programs (depression [n=32], anxiety disorder [n=17], obsessive-compulsive disorder [n=10], bipolar disorder [n=5], social phobia [n=5], bulimia [n=3], alcohol abuse [n=1], panic disorder [n=10], and insomnia [n=6]), all provided nationwide by Helsinki University Hospital in Finland. The interviews were transcribed verbatim and analyzed with the qualitative Gioia method. RESULTS: Three key categories help explain why users consider therapist support essential for adherence in iCBTs: (1) the strengthening of individual autonomy, (2) the therapist's commitment to strengthening the therapeutic alliance, and (3) assistance with emotion regulation. Therapist support was shown to be pivotal, often conveyed through small, text-based gestures that had a meaningful impact. CONCLUSIONS: The role of the therapist should not be diminished in the pursuit of digitalization, as human support remains a critical element of effective iCBT.
9Diagnosis, treatment, and associated outcomes of later-life insomnia: a narrative review.PubMed
Christopher N Kaufmann, Soomi Lee, Amy S Berkley, et al.
Insomnia is highly prevalent in older adults and is associated with a range of health outcomes. Over the past 10 years, there have been several reviews of the literature concerning insomnia and its outcomes among older individuals; however, there is a need for an updated review examining the emerging themes of research in this space to guide clinical practice and research. Accordingly, in this narrative review, we highlight recent research on insomnia in older adults, documenting the evolution of knowledge regarding insomnia and its consequences as people age. Our review describes trends in the prevalence of insomnia and related symptoms in older adults, as well as potential factors contributing to these trends. We also highlight the growing recognition of insomnia-associated outcomes, specifically focusing on brain and heart health. Given challenges in and barriers to identifying and ultimately treating insomnia, we describe shifts in the ways insomnia is treated with applicability to older adults, including through digital therapeutic modalities that have the potential to increase access to evidence-based behavioral therapies. Our review highlights significant advancements in the understanding of insomnia's role in older adults' health and underscores critical priorities for future research. Statement of Significance Insomnia is highly prevalent in older adults and is associated with a growing scope of adverse health outcomes. While barriers exist to its diagnosis and appropriate treatment in older persons, advancements in the field of sleep medicine, such as expanded pharmacological options and digital therapeutics for behavioral sleep treatments, may help address the unmet need for care. Our narrative review seeks to trace these developments in the hopes of spurring future research to address insomnia in the growing population of older adults.
10Digital Cognitive Behavioral Therapy for Chronic Insomnia in South Korea: Cost-Effectiveness Analysis Using Decision Tree and Markov Modeling Based on a Secondary Analysis of a Randomized Clinical Trial.PubMed
Jung Hyun Kim, Minjeong Sohn, Jimin Woo, et al.
BACKGROUND: Insomnia is a prevalent sleep disorder characterized by difficulty initiating or maintaining sleep and is associated with substantial health and economic burdens. Although cognitive behavioral therapy (CBT) is recommended as the first-line treatment, pharmacotherapy remains widely used despite adverse effects and significant indirect costs related to impaired productivity and workplace safety. Digital therapeutics delivering CBT through mobile platforms have emerged as scalable alternatives to improve access and outcomes. Somzz is a commercially available, domestically developed digital therapeutic that delivers CBT-based interventions for insomnia via a mobile app. OBJECTIVE: This study evaluated the cost-effectiveness of Somzz compared with conventional insomnia treatment combining CBT and pharmacotherapy from both health care system and societal perspectives in South Korea. METHODS: A decision-analytic model integrating a short-term decision tree with a Markov model was developed to compare costs and outcomes of digital CBT via Somzz versus conventional care in 2023. The model simulated a 27-week time horizon (three treatment cycles) and applied an annual discount rate of 4.5%. Clinical inputs, including remission probabilities and health utility values, were derived from a published randomized clinical trial comparing digital CBT delivered via Somzz with sleep hygiene education. Additional inputs, including health care resource use and unit costs, were obtained from published literature and national sources. Health outcomes were measured in quality-adjusted life years (QALYs). The cost analysis included direct medical costs and indirect costs related to absenteeism, productivity loss, and workplace accidents attributable to insomnia. Incremental cost-effectiveness ratios (ICERs) were estimated in 2023 South Korean Won (KRW). Deterministic one-way and probabilistic sensitivity analyses were conducted to assess uncertainty. RESULTS: From a health care system perspective, digital CBT via Somzz resulted in modestly higher costs and improved health outcomes compared with standard care. Over approximately 6.5 months, Somzz generated an additional 0.0092 QALYs per patient at an incremental cost of KRW 79,691 (US $61.87), yielding an ICER of KRW 8,719,727 (US $990,883) per QALY gained. This estimate was well below the Korean willingness-to-pay threshold of KRW 30,000,000 (US $23,192.91) per QALY. From a societal perspective, digital CBT was cost-saving, producing a negative ICER due to reductions in health care utilization, workplace accidents, and productivity losses associated with higher remission rates. Sensitivity analyses identified intervention costs and remission probabilities as key drivers; however, digital CBT remained cost-effective across all scenarios under willingness-to-pay thresholds of KRW 30,000,000 and KRW 15,000,000 per QALY. CONCLUSIONS: Digital CBT for insomnia offers favorable clinical and economic value in South Korea. Using Korean clinical trial data and locally relevant societal cost inputs, this study provides policy-relevant evidence supporting early integration of digital CBT into routine insomnia care, employer health strategies, and national digital health policy. TRIAL REGISTRATION: World Health Organization International Clinical Trials Registry Platform KCT0007292; https://trialsearch.who.int/Trial2.aspx?TrialID=KCT0007292.
11Effectiveness of digital cognitive behavioral therapy for insomnia in nurses with shift work sleep disorder: Results of a randomized controlled trial.PubMed
Hanna A Brückner, Johanna Ell, Lina Kalon, et al.
BACKGROUND: Shift work is associated with many adverse effects on health and, in particular, affects sleep. In nurses, one of the most common forms of insomnia is shift work sleep disorder. Traditional face-to-face cognitive behavioral therapy for insomnia is often impractical for shift-working nurses due to irregular work schedules. Digital therapy presents a promising alternative to provide nurses with access to cognitive behavioral therapy for insomnia. OBJECTIVE: To investigate the effectiveness of the digital SleepCare intervention for reducing insomnia in nurses being affected by shift work sleep disorder. DESIGN: Randomized controlled trial. PARTICIPANTS: 74 nurses affected by shift work sleep disorder. METHODS: In a two-armed randomized controlled trial, SleepCare was compared to shift work-specific psychoeducation published digitally by the German Sleep Society. The diagnosis of shift work sleep disorder was established through a clinical interview. The primary outcome was insomnia severity as measured by the Insomnia Severity Index at baseline before randomization, at 8 weeks, and 3 months after randomization. Further indicators of mental health and long-term hair cortisol concentration were evaluated as secondary endpoints. RESULTS: Intention-to-treat analysis of covariance showed a greater reduction in insomnia severity in the intervention group versus psychoeducation, at both post-intervention (d = 1.11[0.7-1.6]) and follow-up (d = 0.97 [0.5-1.4]), corresponding to between-group differences of 5.0 and 5.3 points on the Insomnia Severity Index, respectively. 56 % completed at least five of the six sessions and results indicated larger effects for these intervention completers with d = 1.49 and d = 1.28, respectively. Statistically significant effects were observed for sleep-related, but not other mental health indicators, for example, stress and depression. Reduced hair cortisol levels were observed post-intervention in the SleepCare group (V = 82, p = .008; Δ = -1.8 pg/mg, 44 % reduction from baseline). CONCLUSIONS: SleepCare was effective in reducing insomnia symptoms to a clinically meaningful extent and is one of the first digitally delivered programs to adapt cognitive behavioral therapy for insomnia with specific exercises to address nurses' needs for shift work. The development of effective strategies to promote treatment adherence seems necessary, as substantially larger effects were observed for intervention completers. REGISTRATION: German Clinical Trials Register - DRKS; DRKS00027411 (https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00027411). Registration date: March 9, 2022. Start of recruitment: May 13, 2022.
12Digital therapeutics in Japan: Present and future directions.PubMed
Akihiro Nomura
Digital therapeutics (DTx) represent an innovative approach to healthcare, leveraging software applications (apps) delivered through digital devices to treat medical conditions. This review focuses on three DTx apps approved in Japan, targeting nicotine dependence, hypertension, and insomnia. CureApp SC, the DTx system for nicotine dependence, comprises a patient smartphone app, an Internet of Things device for exhaled carbon monoxide measurement, and a Web-based physician app. A clinical trial demonstrated significantly higher rates of continuous abstinence in the intervention group than in the controls (63.9 % vs. 50.5 %, p = 0.001) at 24 weeks, with effects persisting through 52 weeks. For hypertension management, CureApp HT focuses on lifestyle modifications with daily home blood pressure monitoring. The HERB-DH1 trial showed a significant reduction in 24-h systolic blood pressure (between-group difference, -2.4 mmHg; p = 0.024) and morning home blood pressure (between-group difference, -4.3 mmHg; p < 0.001) in the intervention group compared with those in the controls. This hypertension DTx app also exhibits potential lifetime cost-effectiveness. Regarding insomnia management, SUSMED MedCBT-i supports physician-delivered cognitive behavioral therapy for insomnia. In a randomized controlled trial, Athens Insomnia Scale scores significantly improved in the intervention group compared with those in the controls (between-group difference, -3.4 point; p < 0.001) at 8 weeks. These DTx apps represent a significant advancement in managing chronic conditions, offering scalable and accessible methods for delivering evidence-based interventions. They also address the challenges in implementing lifestyle modifications and behavioral therapies in traditional healthcare settings. As DTx become more integrated into routine clinical practice, ongoing research is crucial to evaluate their long-term efficacy, safety, and cost-effectiveness. The success of these initial DTx apps in Japan paves the way for more comprehensive digital health solutions, potentially improving individual patient outcomes and contributing to larger-scale public health improvements in managing chronic conditions.
13Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities.PubMed
Takashi Hosono, Yuki Niwa, Masuo Kondoh
BACKGROUND: Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the number of DTx products authorized with the regulatory reviews of the clinical evidence is increasing. Insomnia is one of the major targets of the DTx due to the benefit from cognitive behavioral interventions and several products have been launched in the market with regulatory reviews. However, common features of the products and the clinical evidence required by each regulatory agency have not been investigated. METHODS: In this study, we identified the DTx products with the primary indication of insomnia authorized with regulatory reviews of clinical evidence by literature and website searches, and investigated the common features of the products and of the study designs for the pivotal clinical trials. RESULTS: The total of 6 DTx products were identified. The components of cognitive behavioral therapy for insomnia (CBT-I) were identified as common features of the products. All the pivotal clinical trials were randomized, parallel-group, blind studies against insomnia patients. No products have been authorized in multiple countries regardless of the similarity of the features of the products and of the study designs for the pivotal clinical trials. CONCLUSIONS: Our study revealed that the components of CBT-I and gold standard design in pivotal clinical trials were adopted in all the DTx products for insomnia authorized with reviews of clinical evidence. At the same time, our findings suggest the needs of internationally harmonized regulatory review and authorization system to facilitate the early patient access to the promising DTx products.
14Cognitive behavioral therapy skills via a smartphone app for subthreshold depression among adults in the community: the RESiLIENT randomized controlled trial.PubMed
Toshi A Furukawa, Aran Tajika, Rie Toyomoto, et al.
Subthreshold depression, defined as a depressive status falling short of the diagnostic threshold for major depression, is common, disabling and constitutes a risk factor for future depressive episodes. Cognitive behavioral therapies (CBT) have been shown to be effective but are usually provided as packages of various skills. Little research has been done to investigate whether all their components are beneficial and contributory to mental health promotion. We addressed this issue by developing a smartphone CBT app that implements five representative CBT skills (behavioral activation, cognitive restructuring, problem solving, assertion training and behavior therapy for insomnia), and conducting a master randomized study that included four 2 × 2 factorial trials to enable precise estimation of skill-specific efficacies. Between September 2022 and February 2024, we recruited 3,936 adult participants with subthreshold depression. Among those randomized, the follow-up rate was 97% at week 6 and adherence to the app was 84%. The study showed that all included CBT skills and their combinations differentially beat all three control conditions of delayed treatment, health information or self-check, with effect sizes ranging between -0.67 (95% confidence interval: -0.81 to -0.53) and -0.16 (-0.30 to -0.02) for changes in depressive symptom severity from baseline to week 6, as measured with the Patient Health Questionnaire-9 scores. Knowledge of the active ingredients of CBT can better inform the design of more effective and scalable psychotherapies in the future. (UMIN Clinical Trials Registry UMIN000047124 ).
15Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia.PubMed
Frances P Thorndike, Richard B Berry, Robert Gerwien, et al.
Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. igital eal-world vidence trial for dults with insomnia treated via obile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. NCT04325464 (ClinicalTrials.gov).
16Perspectives on increasing the impact and reach of CBT-I.PubMed
Rachel Manber, Norah Simpson, Nicole B Gumport
Cognitive behavioral therapy for insomnia is now recognized as the front-line treatment for chronic insomnia, yet many challenges remain in improving its impact and reach. This manuscript describes our perspective on some of these challenges. Based on the literature that maladaptive cognitions predict low adherence and that high levels of cognitive-emotional hyperarousal may be associated with poor outcomes, we propose added focus on cognitive therapy strategies in CBT-I. Specifically, we propose broadening the range of traditional cognitive therapy strategies, utilizing acceptance-based strategies, and fuller integration of the broadened range of cognitive strategies into CBT-I throughout the course of treatment. We also highlight a few other promising emerging approaches to enhance the impact of CBT-I. These include involving partners to promote adherence with CBT-I treatment recommendations, using culturally relevant treatment adaptations to increase retention of patients in treatment, and using strategies for timely identification of barriers to engagement. We propose broadening the public health impact of CBT-I by integrating support for reduction in long-term use of hypnotic sleep medications, which is in line with current medical guidelines. We advocate for a case conceptualization-based approach for implementing CBT-I in a patient-centered manner, flexibly, yet with fidelity, to enhance its impact by addressing the factors above. For increasing the reach of CBT-I, we discuss the need to train more clinicians and ways to combine therapist and digital deliveries of CBT-I, highlighting stepped care strategies.
17Efficacy of digital cognitive behavioural therapy for insomnia in Armed Forces and Veteran populations - A systematic review and meta-analysis of randomised controlled trials.PubMed
Alex J Rawcliffe, Sofia Isabel Ribeiro Pereira
BACKGROUND: Insomnia is highly prevalent in Armed Forces (AF) and veteran populations and undermines readiness and quality of life. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is first-line, access is limited in military settings, and although digital CBT-I offers a scalable alternative, evidence in this population remains limited and not systematically synthesised. The aim of this systematic review and meta-analysis is to evaluate the efficacy of digital CBT-I on insomnia severity in AF personnel. METHODS: Four electronic databases (PubMed, CENTRAL, Ovid MEDLINE, Ovid PsycINFO, Ovid Embase, Web of Science) were searched between July 12th 2025 to 30th August 2025, supplemented by grey literature searching. Randomised controlled trials (RCT) of AF personnel with insomnia diagnosed via DSM-5 criteria (n = 5) or Insomnia Severity Index (ISI) ≥ 14 (n = 1) were included. Digital CBT-I interventions were compared with minimum contact controls. Participants were included regardless of age, duty status, comorbidities, intervention modality, or setting. Change in ISI scores at post-treatment were meta-analysed using random-effects models, with follow-up assessed descriptively. Risk of bias was assessed using RoB 2, and certainty of evidence was evaluated using GRADE. RESULTS: Five RCTs (n = 309 intervention; n = 249 control) met inclusion criteria. Pooled post-treatment effects showed a statistically significant moderate-to-large reduction in insomnia severity favouring digital CBT-I, with substantial heterogeneity (I = 74%). Leave-one-out sensitivity analyses indicated that this heterogeneity was largely driven by Chao et al.; removal of this study resulted in a considerable reduction in heterogeneity while the overall effect remained robust. Available follow-up ISI scores indicated maintenance of treatment gains up to 12 months. Three studies reported clinically meaningful ISI reductions (≥6 points). Overall risk of bias was unclear or high, primarily due to limited reporting and attrition. Certainty of evidence was rated moderate. CONCLUSION: Despite limited study numbers, digital CBT-I was shown to be effective in reducing insomnia severity in AF personnel with complex health needs. Future research should address engagement and attrition within digital therapeutics to optimise implementation and treatment efficacy in military settings.
18Digital Delivery of Cognitive Behavioral Therapy for Insomnia.PubMed
Annemarie I Luik, Tanja van der Zweerde, Annemieke van Straten, et al.
PURPOSE OF REVIEW: Digital cognitive behavioral therapy (dCBT) has been available for over a decade. We reviewed the evidence that accumulated over the past 5 years and discuss the implications for introducing dCBT into standard healthcare. RECENT FINDINGS: Studies have consistently supported the use of dCBT to treat insomnia. Evidence is now demonstrating large short-term effects and smaller long-term effects up to 1.5 years after treatment across populations with various co-occurring health problems. The effects also extend into a range of psychological well-being factors. Mediators and moderators have been studied to understand mechanisms and create new opportunities to enhance effectiveness and reduce dropout. Incorporating personalized guidance in dCBT may further enhance effectiveness. The evidence for dCBT for insomnia is strong and suggests that dCBT is ready for application in standard healthcare. Further research, digital innovation, and development of effective implementation methods are required to ensure dCBT fulfills its potential.
19Internet-delivered cognitive behavioral therapy for insomnia: The future of insomnia treatment with large language models.PubMed
Chenxing Lin, Chen Cheng, Yu Xia, et al.
With the rise in the prevalence of insomnia, cognitive behavioral therapy for insomnia (CBT-I) has become an important non-pharmacological approach to the treatment of insomnia patients. Traditional CBT-I faces challenges such as low patient acceptance and long treatment cycles. To address these issues, Internet-delivered Cognitive Behavioral Therapy for Insomnia (eCBT-I) emerged as a digital treatment modality with greater flexibility, accessibility and cost-effectiveness. However, eCBT-I still faces issues such as digital literacy and patient engagement. With the development of artificial intelligence (AI) technology, especially the application of large language models (LLM), AI-driven CBT-I is becoming an important direction for future therapy. The LLM is able to provide personalized treatment recommendations based on patient feedback, improving treatment outcomes and patient engagement. This paper reviews the application status and challenges of CBT-I and eCBT-I, focuses on the potential and prospect of LLM in CBT-I therapy, and proposes future research directions, including multi-source data fusion and privacy protection issues, to promote the innovation and development of CBT-I.
20Validating the Efficacy of a Mobile Digital Therapeutic for Insomnia (WELT-I): Randomized Controlled Decentralized Clinical Trial.PubMed
Kyung Mee Park, Suonaa Lee, Yujin Lee, et al.
BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) has proven to be an effective treatment; however, its accessibility is limited. To address this issue, digital therapeutics for insomnia (DTx-Is), which are software-driven interventions designed to treat insomnia based on CBT-I, have emerged as a potential solution to enhance access. OBJECTIVE: This study aimed to verify the efficacy and safety of WELT-I, a DTx-I. Due to the impact of the global pandemic during the study period, we thought that a decentralized clinical trial (DCT) design that does not require visits to institutions would be appropriate for a clinical study of a digital therapeutic for patients with insomnia. Thus, we also examined the potential of the DCT design as an effective method for validating DTx-Is. METHODS: A double-blind, sham-controlled randomized DCT was conducted with participants who met the diagnostic criteria for insomnia. Participants were recruited through advertisements posted on an open-access website. WELT-I is a DTx-I based on CBT-I. A sham app was engineered to mirror WELT-I's installation, login, user engagement, and content delivery processes while maintaining double-blind protocols. After randomization, participants were asked to use WELT-I or the sham app for 6 weeks. All treatment processes were fully automated. Sleep parameters were measured through an app-based sleep diary. Self-report questionnaires on sleep, depression, and anxiety were administered via the app at baseline and the end of the study. The primary outcome was sleep efficiency. To investigate the feasibility of the DCT design, compliance, retention rate, participant satisfaction, and time to reach the recruitment goal were evaluated. RESULTS: A total of 89 participants provided consent and underwent screening, and 68 participants were randomly assigned to the WELT-I group (n=33) or control group (n=35). Among them, 14 participants discontinued the trial, leaving 54 participants who completed the study and were included in the final analysis (28 in the WELT-I group and 26 in the control group). WELT-I significantly improved sleep efficiency (least-squares difference=8.28; P=.04) and dysfunctional beliefs about sleep (least-squares difference=-1.03; P=.008) compared with the sham app. The study completed recruitment in 73 days, and the compliance rate was 95% (186/196) in the WELT-I group and 91% (165/182) in the control group. Moreover, the retention rate was 82% (23/28), and the average satisfaction score was 7.2 out of 10. CONCLUSIONS: WELT-I showed significant therapeutic efficacy and safety in improving sleep efficiency and sleep-related dysfunctional attitudes in cases of insomnia. In addition, this study demonstrated the feasibility of DCTs, and the findings of rapid recruitment, high compliance and retention rates, and strong participant satisfaction suggest that DCTs have sufficient potential to be expanded to clinical studies verifying the efficacy of other DTx-Is in the future.