Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT06378450
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Response Effects of Mindfulness Meditation
Sponsor:
University of Melbourne
Organization:
Study Overview
Official Title:
Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: