Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial.
Nicholas Bowles, Alexander Burger, Jonathan N. Davies, Julie A Simpson, Julieta Galante, Simon Dennis, Benjamin Stone, Nicholas T. van Dam
JMIR Research Protocols July 29, 2025 DOI: 10.2196/72786 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 688 |
| Population | Healthy adults aged between 18 and 65 years |
| Intervention | Mindfulness meditation |
| Duration | 4-week intervention, 1-month follow-up |
| Topics | Meditation |
| Keywords | Mindfulness meditation mindfulness Practice time Courses Dose-response relationship dose-response Duration Ideal dose Longer sessions Well-being well-being Positive results Enhance well-being Boosting well-being Digital interventions Mobile interventions Online interventions |
| Key findings | The trial hypothesizes that larger doses of mindfulness training will yield significantly larger effects on well-being and that higher doses will be associated with lower participant engagement. |
Abstract
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. DERR1-10.2196/72786.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 23
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Meditation Programs for Psychological Stress and Well-being JAMA Internal Medicine January 6, 2014
- The toronto mindfulness scale: Development and validation Journal of Clinical Psychology 2006
- Long-term meditators self-induce high-amplitude gamma synchrony during mental practice Proceedings of the National Academy of Sciences November 8, 2004
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
and 18 more in the library