Sparacio Alessandro, Davies Jonathan Nicholas, Lee Erin, Schmitt Jeroen Antonius Johannes
Human Development, Institute for Human Development and Potential (IHDP), Agency for Science, Technology and Research, Singapore, Singapore.
School of Psychology, The University of Queensland, St Lucia, Australia.
JMIR Ment Health. 2025 Aug 19;12:e77793. doi: 10.2196/77793.
Fully decentralized self-administered mindfulness interventions show promise for stress reduction, but rigorous evaluations of their feasibility, acceptability, and effectiveness using both self-report and physiological measures remain limited. In Singapore, where mental health concerns rank as the top health care priority (46%), ahead of cancer (38%) and stress-related issues (35%), accessible and scalable interventions are urgently needed to address the significant economic burden of mental health conditions.
This study aimed to evaluate a decentralized, 3-day self-administered mindfulness intervention with minimal supervision, compared with a sham control in Singaporean adults, examining effects on self-reported and physiologically measured stress responses. The inclusion of a sham control condition was intended to disentangle mindfulness-specific effects from demand characteristics and expectation effects, addressing a critical methodological gap in digital mindfulness research.
This was a purely smartphone-based, decentralized pilot trial with no face-to-face components. Participants were recruited using web-based methods and, after providing informed consent, 60 adults were randomized to either a mindfulness intervention or a structurally matched sham control. The daily 10-minute mindfulness sessions guided participants to focus on present-moment breath and body sensations, while the sham control omitted a focus on present-moment awareness. Outcomes were assessed remotely, using self-report questionnaires (State-Trait Anxiety Inventory-6) and physiological data from smartphone-based photoplethysmography (heart rate variability; HRV). The study incorporated three methodological innovations: (1) a structurally equivalent sham control to match expectancy and credibility, (2) remote collection of HRV as an objective physiological biomarker, and (3) full decentralization allowing unsupervised multiplatform delivery. Feasibility was evaluated through recruitment, retention rates, and data quality. Acceptability was assessed through quantitative ratings and qualitative feedback.
The study demonstrated excellent feasibility, with near-perfect retention (59/60, 98.3%) and moderate HRV data quality (231/331, 69.8% valid signals). Acceptability ratings were high (mean 4.17, SD 0.53), with comfort/engagement receiving the highest scores (mean 4.27, SD 0.57) on a 5-point scale, exceeding established usability benchmarks for digital health interventions. Qualitative feedback identified technical challenges (HRV instability and device overheating) and scheduling difficulties. While Bayesian analyses did not detect significant group differences in stress reduction (Bayes factor [BF]=0.03) or HRV improvement (BF=0.2), both groups showed significant stress reductions (BF=3.01×10), suggesting that observed benefits may stem from nonspecific factors common to both interventions.
This study demonstrates (1) the feasibility of conducting fully decentralized mindfulness trials with multimodal assessment, (2) the value of a mixed methods acceptability evaluation, and (3) the identification of key technical and control condition refinements necessary for future trials. By addressing methodological limitations through improved control conditions and objective measures, this study provides a foundation for more rigorous investigation of mindfulness-specific effects.
ClinicalTrials.gov NCT06765889; https://clinicaltrials.gov/study/NCT06765889.
完全去中心化的自我管理正念干预措施在减轻压力方面显示出前景，但使用自我报告和生理测量对其可行性、可接受性和有效性进行的严格评估仍然有限。在新加坡，心理健康问题被列为首要医疗保健重点（46%），高于癌症（38%）和与压力相关的问题（35%），因此迫切需要可及且可扩展的干预措施来应对心理健康状况带来的巨大经济负担。
本研究旨在评估一种去中心化的、为期3天的自我管理正念干预措施，该措施在最少监督的情况下实施，并与新加坡成年人中的假对照进行比较，研究其对自我报告和生理测量的压力反应的影响。纳入假对照条件旨在将正念特定效应与需求特征和期望效应区分开来，填补数字正念研究中的一个关键方法空白。
这是一项完全基于智能手机的去中心化试点试验，没有面对面的环节。使用基于网络的方法招募参与者，在获得知情同意后，60名成年人被随机分为正念干预组或结构匹配的假对照组。每天10分钟的正念课程引导参与者专注于当下的呼吸和身体感觉，而假对照组则忽略对当下意识的关注。使用自我报告问卷（状态-特质焦虑量表-6）和基于智能手机的光电容积脉搏波描记法（心率变异性；HRV）的生理数据进行远程评估结果。该研究纳入了三项方法创新：（1）结构等效的假对照以匹配期望和可信度，（2）远程收集HRV作为客观生理生物标志物，（3）完全去中心化允许无监督的多平台交付。通过招募、保留率和数据质量评估可行性。通过定量评分和定性反馈评估可接受性。
该研究显示出极佳的可行性，保留率近乎完美（59/60，98.3%），HRV数据质量中等（231/331，69.8%有效信号）。可接受性评分较高（平均4.17，标准差0.53），在5分制中，舒适度/参与度得分最高（平均4.27，标准差0.57），超过了数字健康干预措施既定的可用性基准。定性反馈确定了技术挑战（HRV不稳定和设备过热）和安排困难。虽然贝叶斯分析未检测到两组在压力减轻（贝叶斯因子[BF]=0.03）或HRV改善（BF=0.2）方面的显著差异，但两组均显示出显著的压力减轻（BF=3.01×10），这表明观察到的益处可能源于两种干预措施共有的非特异性因素。
本研究证明了（1）进行具有多模态评估的完全去中心化正念试验的可行性，（2）混合方法可接受性评估的价值，以及（3）确定未来试验所需的关键技术和对照条件改进。通过改进对照条件和客观测量来解决方法学局限性，本研究为更严格地研究正念特定效应奠定了基础。
ClinicalTrials.gov NCT06765889；https://clinicaltrials.gov/study/NCT06765889。
