Well-Being, PsychologicalNCT06378450
Dose-Response Effects of Mindfulness Meditation
A study testing Mindfulness meditation guided practice in people with Well-Being, Psychological and Depression, run by University of Melbourne at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Depression
- What is being tested?
- Mindfulness meditation guided practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Contemplative Studies Centre, The University of Melbourne
Carlton, Victoria
Nicholas Van Dam, PhD, +61 3 9035 5511, nicholas.vandam@unimelb.edu.au
About this study
Official title: Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Being tested
- Mindfulness meditation guided practice
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation guided practiceBehavioural
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
| Study group | Role | What they receive |
|---|---|---|
| 10-minute dose | Experimental | Daily guided mindfulness meditation practices of 10-minute duration. Receives: Behavioral: Mindfulness meditation guided practice |
| 20-minute dose | Experimental | Daily guided mindfulness meditation practices of 20-minute duration. Receives: Behavioral: Mindfulness meditation guided practice |
| 30-minute dose | Experimental | Daily guided mindfulness meditation practices of 30-minute duration. Receives: Behavioral: Mindfulness meditation guided practice |
| 3-4 minute minimal dose | Active comparator | 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). Receives: Behavioral: Mindfulness meditation guided practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological wellbeing
Psychological well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), which includes 14 positively worded items of mental well-being for the past 2-weeks, on a 5-point Likert scale from 1 (None of the time) to 5 (All of the time).
Measured: Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcomes (13)
Psychological Distress
Psychological distress will be assessed using the Kessler Psychological Distress Scale (K10), a 10-item self-report measure of psychological distress over the past month, on a 5-point Likert scale from 1 (None of the time) to 5 (All of the time)
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Anxiety
Anxiety will be assessed using (i) the PROMIS Anxiety Short Form, a 7-item measure of the pure domain of anxiety over the past 7 days, on a 5-point Likert scale from 1 (Never) to 5 (Always), and (ii) the Anxiety subscale of the Depression, Anxiety and Stress Scale (DASS-21), a 7-item measure of anxiety over the past 7 days, on a 4-point Likert scale from 0 (Did not apply to me at all - never) to 3 (Applied to me very much, or most of the time).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Depression
Depression (secondary outcome) will be assessed at T0, T0.5, T1, and T2 using the PROMIS Depression Short Form, an 8-item measure of depression over the past 7 days, on a 5-point Likert scale from 1 (Never) to 5 (Always).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Nonattachment
Nonattachment will be assessed using the Nonattachment Scale (NAS-7, which measures the Buddhist notion of nonattachment on a 7-point Likert scale from 1 (Disagree strongly) to 5 (Agree strongly).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Trait Mindfulness
Trait Mindfulness will be assessed with the Five Facet Mindfulness Questionnaire (FFMQ), a 15-item measure that includes five factors representing elements of mindfulness, on a 5-point Likert scale from 1 (Never or very rarely true) to 5 (Very often or always true)
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Decentering
Decentering (secondary outcome) will be assessed at T0, T0.5, T1, and T2 using the Experiences Questionnaire (EQ), an 11-item measure of decentering, on a 5-point Likert scale from 1 (Never) to 5 (All the time).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Equanimity
Equanimity will be assessed with the Two Factor Equanimity Scale (EQUA-S), a 14-item measure of equanimity, on a 5-point Likert scale from 1 (Never) to 5 (Very often or always).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Repetitive Negative Thoughts
Repetitive negative thoughts will be assessed with the Repetitive Negative Thoughts Questionnaire (RNTQ), a 22-item measure of repetitive negative thinking, on a 6-point Likert scale from 1 (Not at all typical of me) to 6 (Extremely typical of me)
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Emotional Regulation
Emotional Reactivity will be assessed using the Perth Emotional Reactivity - Short Form (PERS-S), an 18-item measure of the activation, intensity, and duration of one's emotional responses, on a 5-point Likert scale from 1 (Very unlike me) to 5 (Very like me)
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Attentional Control
Attention Control will be assessed with the Attention Control Scale - Short-Form (ATTC-SF), a 10-item measure that includes two subscales of attention (shifting and focusing), on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Always).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Emotional Reactivity
Emotional Regulation measured by the Perth Emotional Reactivity - Short Form (PERS-S), an 18-item measure of the activation, intensity, and duration of one's emotional responses on a 5-point Likert scale from 1 (Very unlike me) to 5 (Very like me).
Measured: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Social Anxiety
Social Anxiety will be assessed with the Social Anxiety Disorder Severity Scale (SAD-D), a 10-item measure assessing the severity of symptoms of social anxiety in the past 7 days on a 5-point Likert scale from 0 (Never) to 4 (All of the time).
Measured: Baseline, Post-intervention (4 weeks)
Sleep Quality
Sleep will be measured by the single-item Sleep Quality Scale on a 10-point Likert scale: Terrible (1), Poor (2-4), Fair (5-7), Good (7-9) to Excellent (10)
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Van Dam, University of Melbourne
- Investigators
- Nicholas T Van Dam, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378450
- Sponsor's protocol ID
- 2022-23892-31512-2
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant-level de-identified data will be shared via OSF as soon as is reasonably possible.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06378450
- Acronym / sponsor ID
- 2022-23892-31512-2
- Conditions
- Well-Being, Psychological, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10-minute dose | Experimental | Behavioral: Mindfulness meditation guided practiceDaily guided mindfulness meditation practices of 10-minute duration. |
| 20-minute dose | Experimental | Behavioral: Mindfulness meditation guided practiceDaily guided mindfulness meditation practices of 20-minute duration. |
| 30-minute dose | Experimental | Behavioral: Mindfulness meditation guided practiceDaily guided mindfulness meditation practices of 30-minute duration. |
| 3-4 minute minimal dose | Active comparator | Behavioral: Mindfulness meditation guided practiceShort 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditation guided practiceParticipants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program. | Behavioural | 10-minute dose, 20-minute dose, 3-4 minute minimal dose, 30-minute dose |
Primary outcome
Psychological wellbeing
Time frame: Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)
Psychological well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), which includes 14 positively worded items of mental well-being for the past 2-weeks, on a 5-point Likert scale from 1 (None of the time) to 5 (All of the time).
13 secondary outcomes
Psychological Distress
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Anxiety
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Depression
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Nonattachment
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Trait Mindfulness
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Decentering
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Equanimity
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Repetitive Negative Thoughts
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Emotional Regulation
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Attentional Control
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Emotional Reactivity
Time frame: Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Social Anxiety
Time frame: Baseline, Post-intervention (4 weeks)
Sleep Quality
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided. Individual participant-level de-identified data will be shared via OSF as soon as is reasonably possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas T Van Dam principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation guided practice in people with Well-Being, Psychological and Depression, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas T Van Dam, PhD (+61 3 8344 3644, nicholas.vandam@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological wellbeing (time frame: Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.