Examining the Dose-Response Effects of Mindfulness Meditation Interventions on Well-Being: Protocol for a Randomized Controlled Trial

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: dose-response; internet- and mobile-based interventions; meditation; mindfulness; well-being.

Figure 1

CONSORT (Consolidated Standards of Reporting Trials) flow diagram.

Figure 2

Study timeline. Momentary measures collected daily between T0 and T1 are excluded. T0, T0.5, T1, and T2 represent time points before randomization, midintervention (2 weeks after randomization), postintervention (4 weeks after randomization), and follow-up (8 weeks after randomization). ATTC-SF: Attention Control Scale–Short Form; DASS-21: Depression, Anxiety, and Stress Scale; DERS-SF: Difficulties in Emotion Regulation Scale–Short Form; EQ: Experiences Questionnaire; EQUA-S: Two-Factor Equanimity Scale; FFMQ: Five Facet Mindfulness Questionnaire; K10: Kessler Psychological Distress Scale; MRAE: Meditation-Related Adverse Effects Scale; NAS-7: Nonattachment Scale; PERS-S: Perth Emotional Reactivity Scale–Short Form; PROMIS: Patient-Reported Outcomes Measurement Information System; RNTQ: Repetitive Negative Thoughts Questionnaire; SAD-D: Social Anxiety Disorder Severity Scale; SQS: Sleep Quality Scale; WEMWBS: Warwick-Edinburgh Mental Wellbeing Scale.