Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001306808
Ethics application status
Approved
Date submitted
1/09/2021
Date registered
27/09/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Mindfulness Meditation and Relaxation Training on Neural Correlates of Attention in Anxiety
Scientific title
The effects of Mindfulness Meditation and Relaxation Training on Neural Correlates of Attention in Adults aged 18 to 35 with Anxiety
Secondary ID [1] 300120 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 315652 0
Condition category
Condition code
Mental Health 313941 313941 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either a mindfulness meditation or relaxation (active control condition) training intervention. The intervention training will occur over a three-week period (daily exercises or at least 5 separate sessions a week) via a mobile phone app using a mobile phone device in the home setting (averaging 15 mins per day). Participants will have a choice of using their own mobile phone (if compatible), otherwise a mobile phone will be provided for loan by the researchers. Adherence will be determined through mobile phone app usage data, provided directly from the phone apps. In addition, participants will be asked to tick if they completed assigned exercises on a hardcopy form.

The mindfulness meditation training intervention will be delivered by the free mobile phone app ‘Smiling Mind©’. This app contains folders of brief audio recordings of mindfulness meditation exercises (e.g., ‘mindfulness of the breath’, ‘body scan’). Participants will be given instructions on the order of exercises to follow. Exercises assigned for practice on a given day will range from around 10-20 minutes of practice. It is estimated that the average amount of practice assigned per day will be approximately 15 minutes.

Both groups will also receive a mindfulness meditation induction at the pre- and post-intervention experimental sessions. This will include a 10-minute mindful breathing exercise. This will be delivered through a guided ‘mindfulness of the breath’ audio recording freely available on the Centre for Clinical Interventions website (CCI©, Government of Western Australia, 2021). This exercise guides listeners to build awareness of their breathing, notice when their mind wanders, and redirect their attention with a non-judgemental attitude.

Intervention code [1] 316395 0
Treatment: Other
Comparator / control treatment
The relaxation training intervention (active control) will be delivered by the mobile phone app ‘Relax Melodies©’. The Relax Melodies©’ app includes an exercise which assists users to practice slow breathing through a visual-audio timing feature (i.e., inhale for 4 counts, hold for 4, exhale for 4, and hold for 4 before the next breath). They will also be provided with a brief information summary to guide effective practice of the exercise, developed by the researchers. The Relax Melodies app contains musical pieces consistent with recommendations for music-assisted relaxation. Participants will be given a schedule of musical pieces to listen to throughout the intervention. Participants will be given the instructions “sit quietly and enjoy the relaxing music”. Musical pieces will be selected based on recommendations for music-assisted relaxation: “lower tempo, low pitches, containing primarily string composition, regular rhythmic patterns, no extreme changes in dynamics, and no lyrics” (p. 209, Pelletier, 2004). Participants will be instructed to practice the breathing exercise for 3 minutes and then immediately after listen to relaxing music with the Relax Melodies app for 10 minutes. Therefore, practice will be around 13 minutes a day.
Control group
Active

Outcomes
Primary outcome [1] 322333 0
A primary outcome will be EEG spectral data (i.e., alpha power, beta power, theta power, theta/beta ratio). Prior to raw EEG being collected during the 10-minute mindfulness meditation induction, baseline EEG will be collected via 2 cycles of eyes open (1 minute), eyes closed (1 minute) activity (4 minutes in total). The potential effects of meditation practice on EEG spectral data from pre- to post-training will be examined.
Timepoint [1] 322333 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively.
Primary outcome [2] 322334 0
A primary outcome will be mean reaction time on cognitive tasks.

The cognitive tasks will be used to measure specific mechanisms of attention. An emotional Stroop task with threat-related (e.g., disease, murder), positive (e.g., beautiful, celebration), and neutral words (e.g., evening, request) will be used to measure hypervigilance and executive control processes. An emotional flanker task with neutral images as targets and neutral (e.g., cups, paper) or threatening (e.g., weapons, injury, explosions) images as distractors will be used to measure executive control processes. All tasks will be presented on a PC using STIM2 software. According to task instructions, participants will be asked to respond with button presses when particular stimuli (words or images) appear on the screen, providing measures of reaction time .
Timepoint [2] 322334 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively.
Primary outcome [3] 322335 0
A primary outcome will be EEG activity (Amplitude of P1, N2, P3 ERP components) time locked to stimuli during performance of the cognitive tasks. EEG activity will be recorded throughout the cognitive tasks to provide neural measures of attention processes.
Timepoint [3] 322335 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively.
Secondary outcome [1] 378147 0
Mean scores for a questionnaire measure of state anxiety (SUDS; Subjective Units of Distress Scale) will be compared from pre- to post-training/induction.
Timepoint [1] 378147 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [2] 378148 0
Mean scores for a questionnaire measure of state mindfulness (MAAS-State; Mindful Attention Awareness Scale - State Version) will be compared from pre- to post-training/induction.
Timepoint [2] 378148 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [3] 378150 0
Heart rate will be compared from pre- to post-training/induction. This will be measured via electrodes using electrocardiogram recording to verify physiological symptoms of anxiety.
Timepoint [3] 378150 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [4] 378151 0
Skin conductance response (small amounts of sweat from the fingers) will be compared from pre- to post-training/induction. This will be to verify physiological symptoms of anxiety and will be measured using a Powerlab psychophysiology system (ADI instruments, Australia) via LabChart software.
Timepoint [4] 378151 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [5] 378155 0
Mean scores for a questionnaire measure of generalised anxiety (GAD-7; Generalised Anxiety Disorder 7-item scale) will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [5] 378155 0
Initial screening survey, approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [6] 378156 0
Mean scores for a questionnaire measure of psychological distress (K10; Kessler Psychological Distress Scale) will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [6] 378156 0
Initial screening survey, approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [7] 378157 0
Mean scores for a questionnaire measure of worry (PSWQ; Penn State Worry Questionnaire) will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [7] 378157 0
Day 1 (pre-training experimental session), approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [8] 378158 0
Mean scores for the depression, anxiety and stress sub-scales of the DASS-21 (Depression, Anxiety and Stress Scales) questionnaire measure will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [8] 378158 0
Day 1 (pre-training experimental session), approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [9] 378159 0
Mean scores for a questionnaire measure of trait mindfulness (MAAS; Mindful Attention Awareness Scale) will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [9] 378159 0
Day 1 (pre-training experimental session), approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [10] 378161 0
Mean scores for a questionnaire measure of emotion regulation (DERS-18; Difficulties in Emotion Regulation Scale) will be compared from pre- to post-training and from post-training to follow-up.
Timepoint [10] 378161 0
Day 1 (pre-training experimental session), approximately Day 22 (post-training experimental session) and Day 50 (one-month follow-up).
Secondary outcome [11] 400396 0
The mean number of days and minutes of training completed will be calculated. This data will be obtained directly from the phone apps used for the participants' training intervention (i.e., Smiling Mind or Relax Melodies). We will also ask participants to complete a hardcopy practice log.
Timepoint [11] 400396 0
Days 1-21 during the training intervention period.
Secondary outcome [12] 401215 0
Mean scores for a questionnaire measure of the attention state 'Alert' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [12] 401215 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [13] 401216 0
Mean scores for a questionnaire measure of the attention state 'Distracted' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [13] 401216 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [14] 401217 0
Mean scores for a questionnaire measure of the mood state 'Calm' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [14] 401217 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [15] 401218 0
Mean scores for a questionnaire measure of the mood state 'Stressed' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [15] 401218 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [16] 401219 0
Mean scores for a questionnaire measure of the mood state 'Accepting' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [16] 401219 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [17] 401220 0
Mean scores for a questionnaire measure of the attention state 'Aware' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [17] 401220 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [18] 401221 0
Mean scores for a questionnaire measure of the attention state 'Present-Focused' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [18] 401221 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [19] 401222 0
Mean scores for a questionnaire measure of the mood state 'Disinterested' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [19] 401222 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [20] 401223 0
Mean scores for a questionnaire measure of the arousal state 'Fatigued' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [20] 401223 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [21] 401224 0
Mean scores for a questionnaire measure of the attention state 'Attentive' will be compared from pre- to post-training/induction using Visual Analogue Scales (VAS).
Timepoint [21] 401224 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively. Both before and after the mindfulness meditation induction exercises during the pre- and post-training experimental sessions.
Secondary outcome [22] 401225 0
Mean response accuracy on cognitive tasks.

The cognitive tasks will be used to measure specific mechanisms of attention. An emotional Stroop task with threat-related (e.g., disease, murder), positive (e.g., beautiful, celebration), and neutral words (e.g., evening, request) will be used to measure hypervigilance and executive control processes. An emotional flanker task with neutral images as targets and neutral (e.g., cups, paper) or threatening (e.g., weapons, injury, explosions) images as distractors will be used to measure executive control processes. All tasks will be presented on a PC using STIM2 software. According to task instructions, participants will be asked to respond with button presses when particular stimuli (words or images) appear on the screen, providing a measure of response accuracy.
Timepoint [22] 401225 0
Day 1 and approximately Day 22 for pre- and post-training experimental sessions, respectively.
Secondary outcome [23] 407024 0
Mean scores for a questionnaire measure of state anxiety (SUDS; Subjective Units of Distress Scale), administered before the cognitive tasks, will be compared from pre- to post-training.
Timepoint [23] 407024 0
Day 1 (pre-training experimental session) and approximately Day 22 (post-training experimental session), prior to the cognitive tasks.
Secondary outcome [24] 407025 0
Mean scores for a questionnaire measure of the mood state 'Present-focused', administered before the cognitive tasks, will be compared from pre- to post-training using Visual Analogue Scales (VAS).
Timepoint [24] 407025 0
Day 1 (pre-training experimental session) and approximately Day 22 (post-training experimental session), prior to the cognitive tasks.
Secondary outcome [25] 407026 0
Mean scores for a questionnaire measure of the mood state 'Stressed', administered before the cognitive tasks, will be compared from pre- to post-training using Visual Analogue Scales (VAS).
Timepoint [25] 407026 0
Day 1 (pre-training experimental session) and approximately Day 22 (post-training experimental session), prior to the cognitive tasks.
Secondary outcome [26] 407027 0
Mean scores for a questionnaire measure of the mood state 'Distracted', administered before the cognitive tasks, will be compared from pre- to post-training using Visual Analogue Scales (VAS).
Timepoint [26] 407027 0
Day 1 (pre-training experimental session) and approximately Day 22 (post-training experimental session), prior to the cognitive tasks.
Secondary outcome [27] 407028 0
Mean scores for a questionnaire measure of the mood state 'Unhappy', administered before the cognitive tasks, will be compared from pre- to post-training using Visual Analogue Scales (VAS).
Timepoint [27] 407028 0
Day 1 (pre-training experimental session) and approximately Day 22 (post-training experimental session), prior to the cognitive tasks.

Eligibility
Key inclusion criteria
Participants will be screened for inclusion/exclusion using an online screening questionnaire. Females and males aged 18-35 years with high (>10) generalised anxiety symptoms over the past two weeks (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006) will be included. Participants with low meditation and relaxation experience (no more than 15 minutes during an average week over the past year, and less than 20 hours in total over their lifetime), with the exception of movement-based practices (e.g., Tai Chi, yoga for exercise), will be selected based on their responses to a customised meditation / relaxation experience questionnaire. 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 need to speak English as a first language and be able to read English fluently so that they can accurately read words in the Stroop task.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 psychiatric (other than depressive or anxiety disorder) 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 (no more than six occasions in the last six months), current use of prescription medications (excluding the contraceptive pill or antidepressant medication), current sleep disorders, and pregnancy/breast feeding or a high likelihood of pregnancy. Those who report colour blindness will also be excluded as participants will need to be able to distinguish colours to complete the Stroop task. Those with risk of alcohol dependence (scores greater than 16 on the Alcohol Use and Disorders Identification Test; AUDIT; Babor, Higgins-Biddle, Saunders, & Monteiro, 2001) will also be excluded. As the relaxation condition involves deep breathing exercises which can lead to light headedness if not done properly, participants who indicate they have low blood pressure, giddiness or asthma, will need to indicate that this is currently managed in order to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligibility will be determine by an online survey. Those eligible to participant will be allocated to a condition according to a randomisation schedule that will be prepared in advance by the Chief Investigator. Therefore, researchers will not have input or decide what condition a participant is allocated to as this will be determined by the pre-existing schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by the Chief Investigator using an online randomisation program (randomization.com). The randomisation schedule will then be uploaded to Redcap for implementation within the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation conducted in G*Power 3.1.9.2 indicates that 17 participants for each group (total N = 34 participants) is adequate to detect a moderate effect (f=0.25) for within/between interactions (power=0.8, p<.05). Given, the paucity of research using similar specific methodology and primary outcome measures to the current study, a moderate effect size was chosen, as an effect of this size is likely to be psychologically or clinically meaningful (i.e., indicative of observable changes in functioning). To account for likely exclusions during standard data cleaning procedures, we will aim to recruit a total of 50 participants.

Mixed models analyses will be conducted with participants included as random factors. The variables Intervention (mindfulness meditation, relaxation), Time (pre, post, follow-up), Image/word (threatening, neutral, pleasant) and Trial (congruent, incongruent) will be included as fixed factors. Comparable analyses will be performed for P1, N2 and P3 amplitude, RT and accuracy for each task. EEG spectral data will be analysed with the fixed factors Exercise Time (baseline, during induction), Resting State (eyes open, eyes closed) and Intervention (mindfulness meditation, relaxation). Repeated measures ANOVA will be used to examine pre to post differences on the VAS, SUDS, heart rate and skin conductance response.

Repeated measures ANOVA will be used to examine pre to post differences on the following questionnaire measures: MAAS, DERS, GAD-7, DASS-21, PSWQ and K10. Analyses to examine differences for follow-up (one month) will also be performed for the GAD-7. DASS-21. PSWQ, K10, DERS and MAAS.

A secondary follow up analysis will include linear single regression analyses to examine the relationships between predictor (e.g., IPIP, FFMQ, MAAS, DERS) and outcome (e.g., psychological self-report measures, attention changes, intervention adherence/engagement) variables. These will be of an exploratory nature to provide insights and inform future research with larger samples.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This study was planned as part of PhD project, and was delayed and now withdrawn due to the impacts of Covid-19 on the ability to conduct lab-based research.
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 304561 0
University
Name [1] 304561 0
University of Tasmania
Country [1] 304561 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] 304842 0
None
Name [1] 304842 0
Address [1] 304842 0
Country [1] 304842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304987 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 304987 0
Ethics committee country [1] 304987 0
Australia
Date submitted for ethics approval [1] 304987 0
16/12/2019
Approval date [1] 304987 0
27/08/2021
Ethics approval number [1] 304987 0
18592

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

Contacts
Principal investigator
Name 98870 0
Dr Allison Matthews
Address 98870 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 98870 0
Australia
Phone 98870 0
+61 3 62267236
Fax 98870 0
Email 98870 0
[email protected]
Contact person for public queries
Name 98871 0
Allison Matthews
Address 98871 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 98871 0
Australia
Phone 98871 0
+61 3 62267236
Fax 98871 0
Email 98871 0
[email protected]
Contact person for scientific queries
Name 98872 0
Allison Matthews
Address 98872 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 98872 0
Australia
Phone 98872 0
+61 3 62267236
Fax 98872 0
Email 98872 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.