NCT06378450

Dose-Response Effects of Mindfulness Meditation

Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation. The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses. Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses. Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min. Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention.

Detailed description

The study will compare the efficacy of receiving different "doses" of mindfulness training over a 28-day period in a prospective 4-armed, parallel-group randomised controlled trial. Participants will be randomised into one of the 4 groups: 10 minutes of meditation per day, 20 minutes of meditation per day, 30 minutes of meditation per day, or a minimal dose of 3-4 minutes of meditation per day. All participants will be encouraged not to complete any further mindfulness training or practice during the intervention period, apart from informal practice during daily life. Self-reported biopsychosocial measures will be evaluated at four time points; before randomization (baseline; T0), 2 weeks after randomisation (mid-intervention, T0.5), 4 weeks after randomization (post-intervention; T1), and 2 months after randomization (post follow-up; T2). In addition, weekly and daily outcomes will be evaluated between T0 and T1. Individual adherence and meditation-related experiences (including adverse events) will be monitored and compared across treatments. The trial will consist of three main phases: the Run-in Period, the Intervention Period, and the Follow-up period, as described below.

Conditions

• Well-Being, Psychological
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness meditation guided practice	Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2024-04-22
• Last updated: 2025-03-30

Locations

1 site across 1 country: Australia