Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001175167
Ethics application status
Approved
Date submitted
15/08/2019
Date registered
20/08/2019
Date last updated
24/06/2021
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
uSing Meditation App to Reduce ED occupational sTress - SMART trial
Scientific title
A multi-site, parallel group, two-arm randomised controlled trial to test the effectiveness of using a Meditation App in managing occupational stress among ED staff – Trial Protocol
Secondary ID [1] 299028 0
Nil known
Universal Trial Number (UTN)
U1111-1238-7542
Trial acronym
SMART trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
occupational stress
 314036 0
burnout 314037 0
Condition category
Condition code
Mental Health 312425 312425 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised in equal proportions into one of two groups. The experimental group will use a meditation app (Headspace app®) to practice meditation for four weeks. Participants will be encouraged to practice daily, 10 minutes of guided mindfulness-meditation during the four weeks intervention period. The ‘wait to treat’ group will be given access to the app four months later.
In order to promote adherence to the intervention, participants will receive regular text message and email reminders to use the app during the study period by the principal investigator.
Intervention code [1] 315298 0
Treatment: Other
Intervention code [2] 315343 0
Behaviour
Comparator / control treatment
The ‘wait to treat’ group will receive no intervention during the first four months. But the ‘wait to treat’ group will receive same intervention four months later.
Control group
Active

Outcomes
Primary outcome [1] 321077 0
Occupational stress will be measured by the Perceived Occupational Stress Scale.
Timepoint [1] 321077 0
The experimental group will be requested to complete the survey before the intervention (T1), at end of the intervention period (T2) and three months later (T3).

The ‘Wait to treat’ group will be requested to complete the survey at the same time interval (T1, T2, T3) as the experimental group. They will be given same access to the app and instructed to practice daily 10 minutes meditation for four weeks. Participants in the ‘Wait to treat’ group will be requested to complete the survey at end of the intervention period (T4) and three months later (T5).
Secondary outcome [1] 373896 0
Burnout will be measured by the Maslach Burnout Inventory.
Timepoint [1] 373896 0
The experimental group will be requested to complete the survey before the intervention (T1), at end of the intervention period (T2) and three months later (T3).

The ‘Wait to treat’ group will be requested to complete the survey at the same time interval (T1, T2, T3) as the experimental group. They will be given same access to the app and instructed to practice daily 10 minutes meditation for four weeks. Participants in the ‘Wait to treat’ group will be requested to complete the survey at end of the intervention period (T4) and three months later (T5).
Secondary outcome [2] 374060 0
Mindfulness will be measured by the Mindfulness Attention Awareness Scale.
Timepoint [2] 374060 0
The experimental group will be requested to complete the survey before the intervention (T1), at end of the intervention period (T2) and three months later (T3).

The ‘Wait to treat’ group will be requested to complete the survey at the same time interval (T1, T2, T3) as the experimental group. They will be given same access to the app and instructed to practice daily 10 minutes meditation for four weeks. Participants in the ‘Wait to treat’ group will be requested to complete the survey at end of the intervention period (T4) and three months later (T5).
Secondary outcome [3] 374061 0
Wellness will be measured by the Warwick-Edinburgh Mental Well-being Scale.
Timepoint [3] 374061 0
The experimental group will be requested to complete the survey before the intervention (T1), at end of the intervention period (T2) and three months later (T3).

The ‘Wait to treat’ group will be requested to complete the survey at the same time interval (T1, T2, T3) as the experimental group. They will be given same access to the app and instructed to practice daily 10 minutes meditation for four weeks. Participants in the ‘Wait to treat’ group will be requested to complete the survey at end of the intervention period (T4) and three months later (T5).

Eligibility
Key inclusion criteria
• Either permanent or causal staff in the EDs
• Have a daily access to a smartphone with Internet access`
• Able to commit to the four weeks intervention period
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Agency staff or external staff
• Self-reported with a previous diagnosis of psychiatric disease(s) or severe depression
• Have practiced meditation or yoga regularly (practice at least once a week) in the past three months

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A centralized randomisation website (https://www.random.org/) will be used. Randomisation will be in a 1:1 ratio between the two study groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Cleaned survey data will then be transferred from online survey to SPSS Version 25 (IBM Corporation, Armonk, New York, USA). Results will be analysed and reported on an intention to treat (ITT) basis. A statistical significance level of p = 0.05 will be used. Participant characteristics data will be presented in tables using descriptive statistics. Chi-square, t tests or non-parametric tests will be used to compare group difference at baseline demographic and work characteristics. Mixed analysis of covariance (ANCOVA) will be used to compare differences in between the experimental group and the 'wait to treat' group in the amount of change on psychometric scores. The correlation between the mindfulness practice time with psychometric scores will be analysed by using the Pearson correlations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2019
Actual
26/08/2019
Date of last participant enrolment
Anticipated
29/09/2019
Actual
30/09/2019
Date of last data collection
Anticipated
19/06/2020
Actual
20/07/2020
Sample size
Target
100
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14552 0
Logan Hospital - Meadowbrook
Recruitment hospital [2] 14554 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 27566 0
4131 - Meadowbrook
Recruitment postcode(s) [2] 27568 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 303562 0
Hospital
Name [1] 303562 0
Logan Hospital
Country [1] 303562 0
Australia
Funding source category [2] 303611 0
Hospital
Name [2] 303611 0
Redland Hospital
Country [2] 303611 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 303641 0
Hospital
Name [1] 303641 0
Logan Hospital
Address [1] 303641 0
Armstrong Rd &, Loganlea Rd, Meadowbrook QLD 4131
Country [1] 303641 0
Australia
Secondary sponsor category [2] 303702 0
Hospital
Name [2] 303702 0
Redland Hospital
Address [2] 303702 0
Weippin St, Cleveland QLD 4163
Country [2] 303702 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304092 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 304092 0
Ethics committee country [1] 304092 0
Australia
Date submitted for ethics approval [1] 304092 0
Approval date [1] 304092 0
21/03/2019
Ethics approval number [1] 304092 0
Ethics committee name [2] 304094 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 304094 0
Ethics committee country [2] 304094 0
Australia
Date submitted for ethics approval [2] 304094 0
Approval date [2] 304094 0
09/05/2019
Ethics approval number [2] 304094 0

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

Contacts
Principal investigator
Name 95790 0
Mrs Hui (Grace) Xu
Address 95790 0
School of Nursing, Midwifery and Social Work, Level 3 Chamberlain Building, St Lucia campus, University of Queensland, St Lucia QLD 4072
Country 95790 0
Australia
Phone 95790 0
+61 7 3346 6787
Fax 95790 0
Email 95790 0
h.xu1@uq.edu.au
Contact person for public queries
Name 95791 0
Hui (Grace) Xu
Address 95791 0
School of Nursing, Midwifery and Social Work, Level 3 Chamberlain Building, St Lucia campus, University of Queensland, St Lucia QLD 4072
Country 95791 0
Australia
Phone 95791 0
+61 7 3346 6787
Fax 95791 0
Email 95791 0
h.xu1@uq.edu.au
Contact person for scientific queries
Name 95792 0
Hui (Grace) Xu
Address 95792 0
School of Nursing, Midwifery and Social Work, Level 3 Chamberlain Building, St Lucia campus, University of Queensland, St Lucia QLD 4072
Country 95792 0
Australia
Phone 95792 0
+61 7 3346 6787
Fax 95792 0
Email 95792 0
h.xu1@uq.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


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
SourceTitleYear of PublicationDOI
EmbaseEffects of mobile mindfulness on emergency department work stress: A randomised controlled trial.2022https://dx.doi.org/10.1111/1742-6723.13836
N.B. These documents automatically identified may not have been verified by the study sponsor.