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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06378450




Registration number
NCT06378450
Ethics application status
Date submitted
17/04/2024
Date registered
22/04/2024

Titles & IDs
Public title
Dose-Response Effects of Mindfulness Meditation
Scientific title
Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial
Secondary ID [1] 0 0
2022-23892-31512-2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-Being, Psychological 0 0
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mindfulness meditation guided practice

Experimental: 10-minute dose - Daily guided mindfulness meditation practices of 10-minute duration.

Experimental: 20-minute dose - Daily guided mindfulness meditation practices of 20-minute duration.

Experimental: 30-minute dose - Daily guided mindfulness meditation practices of 30-minute duration.

Active comparator: 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).


BEHAVIORAL: Mindfulness meditation guided practice
Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psychological wellbeing
Timepoint [1] 0 0
Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [1] 0 0
Psychological Distress
Timepoint [1] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [2] 0 0
Anxiety
Timepoint [2] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [3] 0 0
Depression
Timepoint [3] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [4] 0 0
Nonattachment
Timepoint [4] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [5] 0 0
Trait Mindfulness
Timepoint [5] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [6] 0 0
Decentering
Timepoint [6] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [7] 0 0
Equanimity
Timepoint [7] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [8] 0 0
Repetitive Negative Thoughts
Timepoint [8] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [9] 0 0
Emotional Regulation
Timepoint [9] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [10] 0 0
Attentional Control
Timepoint [10] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [11] 0 0
Emotional Reactivity
Timepoint [11] 0 0
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)
Secondary outcome [12] 0 0
Social Anxiety
Timepoint [12] 0 0
Baseline, Post-intervention (4 weeks)
Secondary outcome [13] 0 0
Sleep Quality
Timepoint [13] 0 0
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
860
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Contemplative Studies Centre, The University of Melbourne - Carlton
Recruitment postcode(s) [1] 0 0
- Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas T Van Dam
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicholas T Van Dam, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8344 3644
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06378450