Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001393842
Ethics application status
Approved
Date submitted
22/09/2021
Date registered
15/10/2021
Date last updated
26/05/2024
Date data sharing statement initially provided
15/10/2021
Date results information initially provided
26/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictors of engagement in mindfulness meditation practice in people with high anxiety
Scientific title
Predictors of engagement in mindfulness meditation practice in adults aged 18-40 with high anxiety
Secondary ID [1] 305277 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 323573 0
Condition category
Condition code
Mental Health 321121 321121 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention training will occur over a two-week period via participants' own mobile phone device within the home context. Eligible participants will complete questionnaires and receive instructions relating to the app-based intervention on an online platform that they will self-enroll in. The training 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 to practice mindfulness meditation exercises using the app for at least 10 minutes daily. They will be encouraged to first watch three brief animated videos on the Smiling Mind app (about one minute in length each) that explain what mindfulness is, how it is beneficial, and how it can be practiced. However, they will be instructed that they will be free to decide which exercises they practice and if they practice for more than 10 minutes a day.

Adherence will be determined through mobile phone app usage data, provided to researchers directly from the phone app with the participants' consent. In addition, participants will
be asked to indicate the amount of minutes and days they practiced mindfulness during the intervention period in a post-treatment online questionnaire.
Intervention code [1] 321679 0
Treatment: Other
Comparator / control treatment
A control group will not be used in this investigation as the primary aim of the research is to identify predictors of engagement in an app-based mindfulness intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328911 0
A main primary outcome will be mean scores for symptoms of generalised anxiety using a questionnaire measure (GAD-7; Generalised Anxiety Disorder 7-item scale). Scores will be compared from pre- to post-training.
Timepoint [1] 328911 0
Initial screening survey (pre-intervention) and approximately Day 15 (post-intervention online questionnaire).
Primary outcome [2] 328912 0
Mean scores for the anxiety sub-scale of the DASS-21 (Depression, Anxiety and Stress Scales) questionnaire measure will be compared from pre- to post-intervention.
Timepoint [2] 328912 0
Day 1 (pre-intervention online questionnaire) and approximately Day 15 (post-intervention online questionnaire).
Primary outcome [3] 328913 0
Mean scores for a questionnaire measure of worry (PSWQ; Penn State Worry Questionnaire) will be compared from pre- to post-intervention.
Timepoint [3] 328913 0
Day 1 (pre-intervention online questionnaire) and approximately Day 15 (post-intervention online questionnaire).
Secondary outcome [1] 400850 0
Mean scores for the depression sub-scale of the DASS-21 (Depression, Anxiety and Stress Scales) questionnaire measure will be compared from pre- to post-intervention.
Timepoint [1] 400850 0
Day 1 (pre-intervention online questionnaire) and approximately Day 15 (post-intervention online questionnaire).
Secondary outcome [2] 400851 0
Mean scores for the stress sub-scale of the DASS-21 (Depression, Anxiety and Stress Scales) questionnaire measure will be compared from pre- to post-intervention.
Timepoint [2] 400851 0
Day 1 (pre-intervention online questionnaire) and approximately Day 15 (post-intervention online questionnaire).
Secondary outcome [3] 401175 0
Another outcome measure will be behavioural engagement in the mindfulness meditation intervention. The mean number of days and minutes of mindfulness meditation practice completed will be calculated. This data will be obtained directly from the phone app used for the participants' training intervention (i.e., Smiling Mind). We will also ask participants to report this information from their app history in a post-intervention online questionnaire.
Timepoint [3] 401175 0
Days 1-14 during the training intervention period.
Secondary outcome [4] 401176 0
Another outcome measure will be participants' intention to practice mindfulness meditation over the two-week intervention period. This will be measured using a Theory of Planned Behaviour questionnaire used in a previous study by Crandall, Cheung, Young, and Hooper (2019).
Timepoint [4] 401176 0
Day 1 at the pre-intervention online questionnaire.

Eligibility
Key inclusion criteria
Participants will be screened for inclusion/exclusion using an online screening questionnaire. In order to be included in the study, participants will need to indicate that they are between 18-40 years old, live in Australia, and have normal or corrected-to-normal vision. They will need to indicate that they are able to read and understand English fluently (so they are able to read task stimuli and instructions clearly). Participants will also need to meet a questionnaire cut-off for high levels of generalised anxiety (>8 on Generalised Anxiety Disorder 7-item Scale/GAD-7). Participants will also need to have their own Android or iPhone smartphone in order to download and use the mindfulness meditation app (Smiling Mind).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they indicate they have epilepsy, other neurological or psychiatric disorders (with the exception of a depressive or anxiety disorder, OCD, or sleep disorder), serious physical health conditions, or have had brain injury or surgery. Those who undertook a Stroop task were excluded if they reported colour blindness, as they needed to be able to distinguish colours to complete the Stroop task. Participants will be asked not to participate if they have used illicit substances on more than 6 occasions in the past 6 months. At the first online component, participants will be asked to refrain from participating if they are intoxicated from, or have recently (i.e., in last two hours) used, alcohol or other substances. Those who undertook a Stroop task were asked to refrain from using nicotine or caffeine during (i.e., while completing) the initial online session.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will include a linear multiple regression analysis to examine the relationship between predictor (i.e., questionnaire measures of generalised anxiety, intolerance of uncertainty, negative problem orientation, cognitive avoidance, positive beliefs about worry, intentions, attitudes, subjective norms, perceived behavioural control, stages of readiness for change, perfectionism, trait mindfulness, meditation experience, and an attentional bias to threat score calculated from a Stroop reaction time task) and outcome (minutes practiced, number of days practiced, intentions to practice, pre-post change in GAD-7 and PSWQ scores) variables.

Initially, a correlation matrix will be estimated, and the univariate regression coefficient will be examined for each independent variable. Coefficients that are relevant to the hypothesised variables that reach statistical significance (p<.05) and are of a small-moderate effect size (r>.2) will be included in a hierarchical regression analysis. G*Power 3.1.9.4 estimates indicates a sample size of 55 (single coefficient) and 135 (full model), is sufficient to detect moderate effects (f2=0.15, a=.05, power=.80) for multiple regression with up to 14 predictors. Given the analysis approach, it was unknown how many predictors would be included in each model. We will aim to recruit a total of 100 participants.

Additionally, paired-samples t-tests will be used to examine pre to post differences on the following questionnaire measures: GAD-7, DASS-21, and PSWQ.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2021
Actual
20/12/2021
Date of last participant enrolment
Anticipated
26/05/2023
Actual
11/05/2023
Date of last data collection
Anticipated
10/06/2023
Actual
28/05/2023
Sample size
Target
100
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309650 0
University
Name [1] 309650 0
University of Tasmania
Country [1] 309650 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] 310664 0
None
Name [1] 310664 0
Address [1] 310664 0
Country [1] 310664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309418 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 309418 0
Research Integrity and Ethics Unit | Research Division University of Tasmania
301 Sandy Bay Road
Hobart TAS 7001
Ethics committee country [1] 309418 0
Australia
Date submitted for ethics approval [1] 309418 0
29/03/2021
Approval date [1] 309418 0
04/08/2021
Ethics approval number [1] 309418 0
24623

Summary
Brief summary
This study aims to identify predictors of engagement in, and outcomes following, a two-week app-based mindfulness intervention in a sample of adults with high levels of generalised anxiety. On an online platform, participants will complete a cognitive task and questionnaires regarding aspects of their mental health, personality traits and patterns in thinking and behaviour. They will then be asked to use the Smiling Mind app to practice mindfulness meditation daily for the next two weeks. App usage data will be obtained directly from Smiling Mind to gain a measure of participant engagement in the intervention. Psychological predictors of engagement in the intervention (minutes and days of practice) and outcome (pre-post change in generalised anxiety symptoms) will then be examined. It is expected that psychological factors related to the maintenance of generalised anxiety will predict poorer engagement outcomes. Outcomes related to anxiety, depression, stress and worry will be examined from pre to post intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114090 0
Dr Allison Matthews
Address 114090 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 114090 0
Australia
Phone 114090 0
+61 3 62267236
Fax 114090 0
Email 114090 0
Allison.Matthews@utas.edu.au
Contact person for public queries
Name 114091 0
Dr Allison Matthews
Address 114091 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 114091 0
Australia
Phone 114091 0
+61 3 62267236
Fax 114091 0
Email 114091 0
Allison.Matthews@utas.edu.au
Contact person for scientific queries
Name 114092 0
Dr Allison Matthews
Address 114092 0
University of Tasmania
Private Bag 30
Hobart, Tas, 7001
Country 114092 0
Australia
Phone 114092 0
+61 3 62267236
Fax 114092 0
Email 114092 0
Allison.Matthews@utas.edu.au

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.