Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial
BackgroundMindfulness 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 m...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-07-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e72786 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850076096755662848 |
|---|---|
| author | Nicholas Bowles Alexander Burger Jonathan N Davies Julie A Simpson Julieta Galante Simon Dennis Benjamin Stone Nicholas T Van Dam |
| author_facet | Nicholas Bowles Alexander Burger Jonathan N Davies Julie A Simpson Julieta Galante Simon Dennis Benjamin Stone Nicholas T Van Dam |
| author_sort | Nicholas Bowles |
| collection | DOAJ |
| description |
BackgroundMindfulness 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.
ObjectiveThe 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.
MethodsAt 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.
ResultsThis 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.
ConclusionsThis 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 |
| format | Article |
| id | doaj-art-1392d3e974364f3aae3028c06c877cc8 |
| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-1392d3e974364f3aae3028c06c877cc82025-08-20T02:46:06ZengJMIR PublicationsJMIR Research Protocols1929-07482025-07-0114e7278610.2196/72786Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled TrialNicholas Bowleshttps://orcid.org/0000-0003-3549-8032Alexander Burgerhttps://orcid.org/0009-0003-6664-4554Jonathan N Davieshttps://orcid.org/0000-0001-7838-126XJulie A Simpsonhttps://orcid.org/0000-0002-2660-2013Julieta Galantehttps://orcid.org/0000-0002-4108-5341Simon Dennishttps://orcid.org/0000-0002-1890-1187Benjamin Stonehttps://orcid.org/0009-0009-0091-0139Nicholas T Van Damhttps://orcid.org/0000-0002-1131-0739 BackgroundMindfulness 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. ObjectiveThe 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. MethodsAt 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. ResultsThis 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. ConclusionsThis 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)DERR1-10.2196/72786https://www.researchprotocols.org/2025/1/e72786 |
| spellingShingle | Nicholas Bowles Alexander Burger Jonathan N Davies Julie A Simpson Julieta Galante Simon Dennis Benjamin Stone Nicholas T Van Dam Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial |
| title_full | Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial |
| title_fullStr | Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial |
| title_short | Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial |
| title_sort | examining the dose response effects of mindfulness meditation interventions on well being protocol for a randomized controlled trial |
| url | https://www.researchprotocols.org/2025/1/e72786 |
| work_keys_str_mv | AT nicholasbowles examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT alexanderburger examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT jonathanndavies examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT julieasimpson examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT julietagalante examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT simondennis examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT benjaminstone examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial AT nicholastvandam examiningthedoseresponseeffectsofmindfulnessmeditationinterventionsonwellbeingprotocolforarandomizedcontrolledtrial |