Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-17
Brief Title:
Dose-Response Effects of Mindfulness Meditation
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 T05 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 T05 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:
None
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?:
None