NCT06378450 Dose-Response Effects of Mindfulness Meditation
| NCT ID | NCT06378450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Melbourne |
| Condition | Well-Being, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 860 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 860 participants in total. It began in 2024-05-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Reside in Australia, with no plans to relocate or travel overseas during the intervention period; * Sufficient comprehension of the English language to complete measures; * Register for an account and agree to the Terms and Conditions of Unforgettable.Me; * If suffering anxious or depressive symptoms of moderate severity (defined by \> 19 on the Patient-Reported Outcomes Measurement Information System \[PROMIS\] Level 2 Anxiety or \> 22 on the PROMIS Level 2 Depression), must agree to continue recommended routine medical treatment for eligible underlying mental and/or physical health conditions or the duration of the study and to seek additional treatment if indicated by deterioration of symptoms; * No or minimal experience with meditation, defined as less than 25 hours over the past 6 months; never attended a multi-day mindfulness course (e.g., Mindfulness-Based Stress Reduction, Vipassana). If 50% of our target sample size has not bee recruited within the first three months of active recruitment, the inclusion criteria will be broadened to include participants with up to 100 hours in the past 6 months. Exclusion Criteria: * Self-reported current or lifetime serious mental illness (e.g., neurodevelopmental, schizophrenia spectrum, bipolar, obsessive-compulsive, trauma-related, dissociative or personality disorder); * Anxious and depressive symptoms in the severe range (defined by \>27 on the PROMIS Level 2 Anxiety or \> 32 on the PROMIS Level 2 Depression); * Psychological distress symptoms in the severe range (Kessler Psychological Distress Scale \[K10\] \>= 30); * Threshold scores on pre-screening and follow-up measures exceeded for Mania, Suicidal Ideation, Psychosis, Repetitive Thoughts \& Behaviors, Dissociation * Moderate alcohol, tobacco, or drug use; * Self-reported diagnosis of neurological condition (e.g., traumatic brain injury, amnesia, epilepsy, stroke, etc.); * Self-reported presence of any serious medical condition (e.g., cancer, thyroid disorder, multiple sclerosis, etc.); * Recent bereavement or major loss; * History of unexplored, untreated traumatic experiences or adverse childhood events.
Contact & Investigator
Nicholas T Van Dam
PRINCIPAL INVESTIGATOR
University of Melbourne
Frequently Asked Questions
Who can join the NCT06378450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Well-Being, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378450 currently recruiting?
Yes, NCT06378450 is actively recruiting participants. Contact the research team at nicholas.vandam@unimelb.edu.au for enrollment information.
Where is the NCT06378450 trial being conducted?
This trial is being conducted at Carlton, Australia.
Who is sponsoring the NCT06378450 clinical trial?
NCT06378450 is sponsored by University of Melbourne. The principal investigator is Nicholas T Van Dam at University of Melbourne. The trial plans to enroll 860 participants.