Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
860 participants
INTERVENTIONAL
2024-05-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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10-minute dose
Daily guided mindfulness meditation practices of 10-minute duration.
Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
20-minute dose
Daily guided mindfulness meditation practices of 20-minute duration.
Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
30-minute dose
Daily guided mindfulness meditation practices of 30-minute duration.
Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
3-4 minute minimal dose
Short daily meditation approximating 3-4 minute duration (akin to the breathing space practice in Mindfulness-based Cognitive Therapy or short practices in popular meditation apps).
Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
Interventions
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Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Melbourne
OTHER
Responsible Party
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Nicholas Van Dam
Associate Professor
Principal Investigators
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Nicholas T Van Dam
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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Contemplative Studies Centre, The University of Melbourne
Carlton, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-23892-31512-2
Identifier Type: -
Identifier Source: org_study_id
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