Bowles Nicholas, Burger Alexander, Davies Jonathan N, Simpson Julie A, Galante Julieta, Dennis Simon, Stone Benjamin, Van Dam Nicholas T
Melbourne School of Psychological Sciences, The University of Melbourne, Melbourne, Australia.
JMIR Res Protoc. 2025 Jul 29;14:e72786. doi: 10.2196/72786.
Mindfulness meditation has demonstrated modest benefits for mental health and well-being, although the relationship between practice dose and outcomes is unclear. Meta-analyses and randomized controlled trials have shown mixed results so far, although such results may stem from methodological issues rather than reflecting the absence of an underlying effect. Research outside structured programs suggests that long-term practice time is linked to positive outcomes, but bias due to self-selection over time may explain these results.
The proposed trial aims to test dose-response effects for an online mindfulness meditation course, examining outcomes and participant engagement across different practice doses. In this pragmatic randomized controlled trial, we hypothesize that larger doses of mindfulness training will yield significantly larger effects and different doses will be significantly associated with variation in participant engagement, with lower engagement evident for higher doses.
At least 688 healthy adults aged between 18 and 65 years will be randomized to join one of three 4-week online mindfulness courses with daily practices of varying lengths (ie, 10, 20, or 30 min) against a minimally active control condition (4 min). Psychological well-being will be measured using the Warwick-Edinburgh Mental Wellbeing Scale at the baseline, midintervention, and postintervention time points and at 1-month follow-up. Secondary outcomes are psychological distress, anxiety, depression, social anxiety, nonattachment, trait mindfulness, decentering, equanimity, repetitive negative thoughts, emotion regulation, attention control, and emotional reactivity. Other outcomes will be collected weekly and daily during the intervention period. The primary analysis will be undertaken following the intention-to-treat approach. We will also conduct per-protocol secondary analyses on all outcomes (ie, primary and secondary). In addition, we will systematically monitor for possible adverse experiences.
This study began screening and recruitment in May 2024. Recruitment was paused approximately 6 weeks later after a substantial number of participants were identified as being fraudulent and not meeting the eligibility criteria. Recruitment reopened in October 2024, and by the end of 2024, a total of 70 eligible participants were enrolled. Recruitment recommenced in early 2025 and will continue until the end of March 2025 or until the target sample is reached. We estimate that the results will be published by March 2026.
This study will contribute to the evidence base for mindfulness meditation and the question of how much practice people need to engage in to improve well-being and other psychological outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72786.
正念冥想已被证明对心理健康和幸福感有一定益处，尽管练习时长与效果之间的关系尚不清楚。荟萃分析和随机对照试验目前显示出的结果参差不齐，不过这些结果可能源于方法学问题，而非反映潜在效应不存在。结构化项目之外的研究表明，长期练习时间与积极结果相关，但随着时间推移自我选择导致的偏差可能解释了这些结果。
拟进行的试验旨在测试在线正念冥想课程的剂量反应效应，研究不同练习剂量下的结果及参与者参与度。在这项实用随机对照试验中，我们假设更大剂量的正念训练将产生显著更大的效果，且不同剂量与参与者参与度的变化显著相关，高剂量时参与度较低。
至少688名年龄在18至65岁之间的健康成年人将被随机分配，加入为期4周的三个在线正念课程之一，每天进行不同时长（即10、20或30分钟）的练习，并与最低限度活动的对照条件（4分钟）进行对比。在基线、干预中期、干预后期以及1个月随访时，使用沃里克 - 爱丁堡心理健康量表测量心理健康状况。次要结果包括心理困扰、焦虑、抑郁、社交焦虑、非执着、特质正念、去中心化、平静、重复性消极思维、情绪调节、注意力控制和情绪反应性。在干预期内，每周和每天还将收集其他结果。主要分析将采用意向性分析方法。我们还将对所有结果（即主要和次要结果）进行符合方案的次要分析。此外，我们将系统监测可能的不良体验。
本研究于2024年5月开始筛选和招募。大约6周后，由于大量参与者被认定为欺诈且不符合资格标准，招募暂停。2024年10月招募重新开始，到2024年底，共招募了70名符合条件的参与者。2025年初招募再次开始，并将持续到2025年3月底或达到目标样本量。我们估计结果将于2026年3月公布。
本研究将为正念冥想的证据基础以及人们需要进行多少练习才能改善幸福感和其他心理结果的问题做出贡献。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/72786
