Dose-Response Effects of Mindfulness Meditation

NCT06378450 | Recruiting

• 1 other identifier: 2022-23892-31512-2
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-Being, Psychological; Depression

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)

Secondary Outcomes (13)

• Psychological Distress

  Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)

• Anxiety

  Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)

• Depression

  Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)

• Nonattachment

  Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)

• Trait Mindfulness

  Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)

Other Outcomes (5)

• Momentary Mood

  Daily pre and post meditation session (i.e. Days 1 through 28 excluding 4 rest days)

• State Mindfulness

  1 of 4 measures randomly assigned on days 1 through 28 excl. rest days (i.e. random assignment occurs on 24 days)

• Attention

  1 of 4 measures randomly assigned on days 1 through 28 excl. rest days (i.e. random assignment occurs on 24 days)

Study Arms (4)

10-minute dose

EXPERIMENTAL

Daily guided mindfulness meditation practices of 10-minute duration.

Behavioral: Mindfulness meditation guided practice

20-minute dose

EXPERIMENTAL

Daily guided mindfulness meditation practices of 20-minute duration.

Behavioral: Mindfulness meditation guided practice

30-minute dose

EXPERIMENTAL

Daily guided mindfulness meditation practices of 30-minute duration.

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).

Behavioral: Mindfulness meditation guided practice

Interventions

Mindfulness meditation guided practice BEHAVIORAL

Participants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.

10-minute dose; 20-minute dose; 3-4 minute minimal dose; 30-minute dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

Contemplative Studies Centre, The University of Melbourne

Carlton, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Study Officials

• Nicholas T Van Dam

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas T Van Dam, PhD

CONTACT

+61 3 8344 3644; nicholas.vandam@unimelb.edu.au

Nicholas I Bowles

CONTACT

+61 3 8344 3644; nbowles@student.unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

AU (1)