Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000825156
Ethics application status
Approved
Date submitted
29/05/2019
Date registered
7/06/2019
Date last updated
21/06/2021
Date data sharing statement initially provided
7/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Mindfulness Meditation and Relaxation on Neural Correlates of Attention: A pilot study
Scientific title
The Effects of Mindfulness Meditation and Relaxation on Neural Correlates of Attention in Healthy Adults: A pilot study
Secondary ID [1] 298254 0
None
Universal Trial Number (UTN)
U1111-1233-5426
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 312856 0
Condition category
Condition code
Mental Health 311354 311354 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either the intervention group or the control group. The intervention group will complete Mindfulness Meditation practice via the Muse mobile phone application (including neurofeedback via brain sensing headband). Participants will complete daily 20-min sessions for 7 days in their own homes. Practice will be via the 10 lesson "Muse Essentials" introductory course included in the Muse mobile application (1. Intro to Muse, 2. Training a puppy, 3. Sensation of breath 4. Counting breaths, 5. Sitting comfortably, 6. Finding your soundscape, 7. Dealing with distraction, 8. working with discomfort, 9. Lowering the bar, 10. Bridging to daily life). During each 20 minute session, participants wear the Muse headband and listen to a brief tutorial on specific aspects of mindfulness meditation from the 10 lesson course (with two course tutorials covered in the first three sessions, and one in each session after) followed by mindfulness meditation practice (involving focused breath). During each meditation practice session, audio feedback is provided when brain signals are active (stormy weather), neutral (calm weather), or calm (bird sounds). This neurofeedback is argued to enhance ability to identify mind wandering and to refocus attention on the breath. The aim is to increase/maximise the number of ‘birds’ in each session. All sessions and progress are recorded within the app.
Intervention code [1] 314498 0
Behaviour
Intervention code [2] 314641 0
Treatment: Other
Comparator / control treatment
A separate control group will complete relaxation practice via a mobile phone application (including biofeedback via 'the Pip' skin conductivity device). Participants will complete daily 20-min sessions for 7 days in their own homes. Participants hold the device and measurement of electrodermal activity are transmitted via Bluetooth to a mobile phone app to determine progress in the app. A dragon racing app (Race and Relax) and the Loom app will be used. In the dragon racing app, the more relaxed an individual is (as indicated by reduced electrodermal activity) the more progress they make in the game (beating their previous race times). In the Loom app, as an individual becomes more relaxed (as indicated by reduced electrodermal activity) the visual scene slowly changes (e.g., snow melts to go from a winter to summer scene).
Control group
Active

Outcomes
Primary outcome [1] 320235 0
Reaction Time for the Attentional network task (i.e., behavioural performance related to orienting, alerting and executive control networks of attention)
Timepoint [1] 320235 0
Day 8 post-intervention
Primary outcome [2] 320236 0
N1 ERP amplitude time locked to stimuli during performance on Attentional Network Task (i.e., ERP measure of alerting and orienting networks)
Timepoint [2] 320236 0
Day 8 post-intervention
Primary outcome [3] 320237 0
N2/P3 ERP amplitude time locked to stimuli during performance on Attentional Network Task (i.e., ERP measures of executive Control)
Timepoint [3] 320237 0
Day 8 post-intervention
Secondary outcome [1] 370951 0
Reaction time to emotional stimuli for the emotional Stroop task (behavioural performance related to executive control over emotional stimuli). This is measured by the reaction time difference between emotional and neutral words during the performance of Stroop task in which participants word stimuli are presented and participants respond with a button press to the colour 'ink' that each word is presented, thereby measuring executive control over distraction from emotional stimuli.
Timepoint [1] 370951 0
Day 8 post-intervention
Secondary outcome [2] 370952 0
N2/P3 ERP amplitude time locked to stimuli during performance of the Emotional Stroop task (i.e., ERP measures of executive control over emotional stimuli). EEG activity will be recorded throughout performance of the Emotional Stroop task described above. Change in amplitude of the N2 and P3 ERP components will be measured from pre-to-post intervention, with difference in amplitude for emotional and neutral word stimuli analysed as a neural correlate of executive control over emotional stimuli.
Timepoint [2] 370952 0
Day 8 post-intervention
Secondary outcome [3] 370953 0
measures of brain activity (EEG) within the spectral domain (i.e., alpha power, theta power, alpha/beta ratio, and theta/beta ratio) during a focused breath task, indicative of relaxed but focused attention and enhanced cognitive control
Timepoint [3] 370953 0
Day 8 post-intervention
Secondary outcome [4] 370954 0
Questionnaire measures of trait mindfulness (MAAS) will be compared from pre- to post-training.
Timepoint [4] 370954 0
Day 8 post-intervention
Secondary outcome [5] 371061 0
Questionnaire measures of mood (Profile of Mood State questionnaire: POMS) will be compared from pre- to post-training. Mood
Timepoint [5] 371061 0
Day 8 post-intervention
Secondary outcome [6] 371062 0
Questionnaire measures of State Anxiety (STAI) will be compared from pre- to post-training.
Timepoint [6] 371062 0
Day 8 post-intervention
Secondary outcome [7] 371063 0
Questionnaire measures of State emotional regulation (DERS-S) will be compared from pre- to post-training.
Timepoint [7] 371063 0
Day 8 post-intervention
Secondary outcome [8] 371289 0
Questionnaire measure of trait mindfulness (CAMS-R) will be compared from pre- to post-training.
Timepoint [8] 371289 0
Day 8 post-training

Eligibility
Key inclusion criteria
Participants with low video game experience (0-1 hours per week in last year) and low meditation/relaxation experience (no experience, or none in last year and less than 5 hours in lifetime) will be selected based on their responses to the Video Game Playing Questionnaire (VGPQ) (Bediou et al., 2018), and a customised meditation / relaxation experience questionnaire. Participants will be male and female, aged between 18 and 35. Only right-handed individuals will be recruited due to their more consistent lateralisation of brain areas. Participants will have normal or corrected-to-normal vision and hearing, so they are able to see the stimuli and hear instructions clearly. In addition, all participants will speak English as a first language to account for differences in processing language related stimuli such as the letter/symbol stimuli used in the cognitive tasks.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Standard exclusion criteria for EEG/ERP research will also apply, so that any differences in brain activity are not attributable to other factors. These exclusion criteria include: any history of major psychiatric or neurological disorders (including epilepsy), severe head injury, seizure, giddiness or loss of consciousness (>2 mins), a heart condition or any other serious physical condition, current daily tobacco use, recent history of illicit drug use, current use of prescription medications (excluding the contraceptive pill), current sleep disorders, and pregnancy or a high likelihood of pregnancy. Those with high levels of Psychological distress (scores >30 on the Kessler Psychological Distress Scale – K10) or risk of alcohol dependence (scores greater 16 on the Alcohol Use and Disorders Identification Test (AUDIT) will also be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligibility will be determine by online survey prior to randomisation of participants according to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated by the Chief Investigator using an online randomisation program (randomization.com).

Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is parallel groups randomised design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To analyse the effects of training group on EEG measures during the focused breath task, a mixed models analysis will be conducted with fixed factors of Training group (either AVG/nonAVG or mindfulness/relaxation), Session (pre and post training) and Condition (eyes open, eyes closed, focused breath). Participants will be included as random factors. Comparable analyses will be conducted on RT, accuracy, and ERP measures for the Stroop task (Fixed factors: Group, Session, Word valence) and ANT task (Fixed factors: Group, Session, Cue type, Target Congruency). Repeated measures ANOVA will be used to examine pre to post differences on the following questionnaire measures: Trait mindfulness (CAMS, MAAS), DERS-S, POMS, and STAI-S.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
20/07/2019
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
40
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 302794 0
University
Name [1] 302794 0
University of Tasmania
Country [1] 302794 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
University of Tasmania
Private Bag 30
Hobart, TAS, 7001
Country
Australia
Secondary sponsor category [1] 302742 0
None
Name [1] 302742 0
Address [1] 302742 0
Country [1] 302742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303385 0
University of Tasmania Health and Medical HREC
Ethics committee address [1] 303385 0
Ethics committee country [1] 303385 0
Australia
Date submitted for ethics approval [1] 303385 0
18/03/2019
Approval date [1] 303385 0
24/05/2019
Ethics approval number [1] 303385 0
H0017994

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

Contacts
Principal investigator
Name 93490 0
Dr Allison Matthews
Address 93490 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 93490 0
Australia
Phone 93490 0
+61 3 62267236
Fax 93490 0
Email 93490 0
[email protected]
Contact person for public queries
Name 93491 0
Allison Matthews
Address 93491 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 93491 0
Australia
Phone 93491 0
+61 3 62267236
Fax 93491 0
Email 93491 0
[email protected]
Contact person for scientific queries
Name 93492 0
Allison Matthews
Address 93492 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 93492 0
Australia
Phone 93492 0
+61 3 62267236
Fax 93492 0
Email 93492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no current plans regarding data sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.