Dose-Response Effects of Mindfulness Meditation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Melbourne
About this 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.
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness meditation guided practice
BehavioralParticipants will listen to recordings of mindfulness meditation practices from a newly developed 28-day program.
Treatment groups
860 Participants
are divided into 4 treatment groupsGroup A: 10-minute doseExperimental treatment 1 intervention
Group B: 20-minute doseExperimental treatment 1 intervention
Group C: 30-minute doseExperimental treatment 1 intervention
Group D: 3-4 minute minimal doseActive comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline, Post-intervention (4 weeks), Follow-up (8 weeks)Secondary outcomes
1
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)
Time frame
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)2
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).
Time frame
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)3
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).
Time frame
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)4
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).
Time frame
Baseline, Mid-intervention (2 weeks), Post-intervention (4 weeks), Follow-up (8 weeks)Other outcomes
1
Momentary Mood
Momentary mood will be assessed daily, before and after each meditation session with a modified English version of the Multidimensional Mood Questionnaire (MDMQ). The MDMQ assesses valence, arousal, and calmness dimensions of momentary mood using six items on a 7-point Likert scale (with end-points labelled "very"). Participants will respond to the statement "At this moment I feel:" 1. tired-awake; 2. content-discontent; 3. agitated-calm; 4. energetic-lacking energy; 5. well-unwell; 6. relaxed-tense.
Time frame
Daily pre and post meditation session (i.e. Days 1 through 28 excluding 4 rest days)2
State Mindfulness
State mindfulness will be assessed with a brief 6-item version of the State Mindfulness Scale (SMS) on a 5-point Likert scale with options ranging from 1 (Not at all) to 5 (Very well).
Time frame
1 of 4 measures randomly assigned on days 1 through 28 excl. rest days (i.e. random assignment occurs on 24 days)3
Attention
Attention will be assessed with the attention regulation and self-regulation subscales of the Multidimensional Assessment of Interoceptive Awareness (MAIA) on a 6-point Likert scale ranging from 1 (Never) to 6 (Always).
Time frame
1 of 4 measures randomly assigned on days 1 through 28 excl. rest days (i.e. random assignment occurs on 24 days)4
Decentering
Decentering will be assessed with a brief 5-item version of the Decentering Subscale of the Toronto Mindfulness Scale (TMS) on a 6-point Likert scale ranging from 1 (Not at all) to 6 (Very much).
Time frame
1 of 4 measures randomly assigned on days 1 through 28 excl. rest days (i.e. random assignment occurs on 24 days)Sponsors and contacts
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Source ClinicalTrials.gov