Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001386325
Ethics application status
Approved
Date submitted
8/09/2017
Date registered
29/09/2017
Date last updated
8/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
App-based Mindfulness Training for Employee Stress Protection
Scientific title
Evaluating the effectiveness of app-based mindfulness training, with and without class-attendance, for reducing stress in a public service workforce.
Secondary ID [1] 291950 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 303297 0
Condition category
Condition code
Mental Health 302726 302726 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 304096 304096 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two intervention arms in this study are:

Arm 1. App group will use the Smiling Mind Workplace App for self-guided progression.

Arm 2. App+ group will use the Smiling Mind Workplace App, and attend four 1-hour seminars.

The Smiling Mind Workplace App (the App) is a complete online learning tool for mindfulness training. The App’s modules (Everyday Mindfulness, Calm, Clarity, Connection and Mindful Mastery) each include instructional videos, meditations (e.g. 7 and 15-minute sitting and body scan practices) and brief practices and activities to help bring moments of informal mindfulness into the everyday (e.g. 1 and 3-minute practices for moving with awareness between meetings, breathing techniques, and listening). In total, there are 41 different App elements. While the App provides user guidance, the amount of time spent each day engaging with App elements is at the discretion of participants. The App is supported by fortnightly email communications for the first 10 weeks, which include suggestions for how to use App elements, e.g. “Find a time that works for you each day, maybe it’s first thing in the morning, or before you go to sleep. Create a routine”; and “Listen to 'Brain Break: the breath' when you need a brief moment during your day to stop and reset”. The App can be used as a stand alone training program or can be offered in conjunction with face to face seminars, which are run in the initial 10 week period. Licences to the full App content last for 12-months.

The four seminars (attended by the App+ group) will be held at multiple locations at three different times in weeks 1, 2, 4 and 6, and be delivered by an experienced organisational consultant and mindfulness teacher. Attendance will be in-person or via video-conference. Each seminar has a key message: choosing to respond mindfully to stressors; remaining calm in the face of demands; managing attention wisely; and cultivating good relationships with the self and others.

Attendance at the seminars will be collected by self-report, and venue count data. User data from the Smiling Mind Servers will enable objective assessment of adherence to the App program. Participant ratings of the usefulness of the seminars and different elements of the App will also be collected.
Intervention code [1] 298075 0
Treatment: Other
Intervention code [2] 299199 0
Behaviour
Comparator / control treatment
The two interventions (App and App+) will be compared with each other and a wait-list control (WLC) group from Baseline (T0) to 3-months from baseline (T1). Following T1, the App and App+ groups will be compared with each other at 6-months (T2) and 12-months (T3) from Baseline. The WLC group will commence training with a single 2-hour seminar, followed by self=guided progression with the App.
Control group
Active

Outcomes
Primary outcome [1] 302119 0
Perceived Stress Scale - 10 item
Timepoint [1] 302119 0
The primary time point for this study is post-intervention assessment (T1), 3 months from baseline.
Secondary outcome [1] 334867 0
Health-related lost productive time. This outcome is assessed using participant self reports of absenteeism and presenteeism days over the preceding 4-weeks. The number of inefficient days is calculated from the reported number of presenteeism days and self-rated productivity on those days (e.g. six presenteeism days at 60% productivity: [(100–60%) × 6 days] = 2.4 inefficient days. Total lost productive time is the sum of absenteeism days and inefficient days.
Timepoint [1] 334867 0
Health-related lost productive time will be collected for the 4-weeks prior to Baseline (T0), then 3 months (T1), 6 months (T2) and 12 months (T3) from baseline.
Secondary outcome [2] 334868 0
Mindful Attention and Awareness Scale
Timepoint [2] 334868 0
Baseline (T0) and post-intervention assessments at 3 months from baseline (T1). Follow-up assessments at 6 months (T2) and then 12 months (T3) from baseline
Secondary outcome [3] 334869 0
Kessler-10 Measure of Psychological Distress
Timepoint [3] 334869 0
Baseline (T0) and post-intervention assessments at 3 months from baseline (T1). Follow-up assessments at 6 months (T2) and then 12 months (T3) from baseline
Secondary outcome [4] 334873 0
Health-related quality of life will be assessed using the Assessment of Quality of Life 8 Dimension instrument (AQoL-8D), a multi-attribute utility instrument which provides data for Physical (independent living, senses, pain) and Psychosocial (mental health, relationships, coping, self-worth, happiness) domains.
Timepoint [4] 334873 0
The App, App+ and WLC groups will do the AQoL-8D at baseline (T0) and at post-intervention 3 months from baseline (T1); then the App and App+ groups only at 6 months (T2) and then 12 months (T3) from baseline.
Secondary outcome [5] 334874 0
Organisational citizenship behaviours, using Smith's 16-item Organizational Citizenship Behaviour questionnaire (Informant report)
Timepoint [5] 334874 0
Baseline (T0) and post-intervention assessments at 3 months from baseline (T1), then at 6 months (T2) and then 12 months (T3) from baseline.
Secondary outcome [6] 334907 0
Workplace incidents (safety, damage, conflict, achievement or success). The World Health Organization Health and Performance Questionnaire (HPQ) item A8 is used for this outcome.
Timepoint [6] 334907 0
Baseline (T0) and post-intervention assessments at 3 months from baseline (T1), then at 6 months (T2) and then 12 months (T3) from baseline.
Secondary outcome [7] 334908 0
Program adherence will be assessed using participant data from the Smiling Mind Servers throughout the 12 month App licence period. This covers usage during the active intervention phase and allows monitoring of ongoing engagement with the App. Seminar attendance will be measured by self-report and count data from seminar venues.
Timepoint [7] 334908 0
Post-intervention 3 months (T1), 6 months (T2) and 12 months (T3) from baseline.
Secondary outcome [8] 334909 0
Perceived usefulness of the program will be assessed using self-report ratings of the App elements, seminar attendance for the App+ group (whether, where and how they attended) and responses from all participants to an open question "Can you please take a few moments to share with us your general impressions of the Smiling Mind Workplace Program?".
Timepoint [8] 334909 0
The App and App+ usefulness data will be collected at post-intervention, 3-months from baseline (T1). The WLC will report usefulness data after they have completed their intervention period, at 6 months from baseline (T2); and all groups will provide responses to a general impressions question again at follow-up, 12 months from baseline (T3).
Secondary outcome [9] 338529 0
Observed Mindfulness Measure - informant reports of the presence and extent of mindfulness of study participants
Timepoint [9] 338529 0
Baseline (T0) and post-intervention assessments at 3 months from baseline (T1). Follow-up assessments at 6 months (T2) and then 12 months (T3) from baseline
Secondary outcome [10] 339037 0
Psychosocial job quality will draw on self-reports of job demand, control and support. Items from the Household, Income and Labour Dynamics (HILDA) Survey for Job Demand and Control; and Support items drawn from the Swedish Job Demand Control Support (JDCS) Survey will be used.
Timepoint [10] 339037 0
Baseline (T0), then at 3 months (T1) 6 months (T2) and 12 months (T3) from baseline

Eligibility
Key inclusion criteria
Inclusion criteria: current employees of Tasmanian Training Consortium (TTC) client organisations with approval to attend seminars, who are not participating in any concurrent health and wellbeing program(s) and who do not have an unmanaged mental health condition,

Eligibility criteria:
1) line managers’ approval to attend all seminars;
2) no concurrent participation in meditation or stress-management programs;
3) PHQ-9 scores less than or equal to 15, and no indication of suicide ideation;
4) evidence of appropriate management for pre-existing mental health condition (assessed by study psychologist)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: concurrent participation in another meditation or stress-management program; not able to attend seminars either in person or via web-link; responses on the baseline survey that indicate a history of borderline personality disorder, significant trauma, suicide ideation or a score greater than 15 on the Patient Health Questionnaire.

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)
Allocation to group will be conducted after baseline surveys are completed, by a statistician independent of the study team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used to randomly allocate participants to group. The full list of participants will be stratified by the presence of an informant or not. Participants with informants will be randomly allocated first, followed by random allocation of participants without informants. This procedure will ensure even distribution of participant-informant pairs across groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In addition to self-report surveys, participants will be asked to invite a work-based person to join the study to act as their observer. Coinciding with the Participant surveys, Observers will complete 5 minute surveys that include two questionnaires about their paired participants (Observed Mindfulness and Organisational Citizenship).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations are based on achieving a Cohen's d effect size of 0.54 for PSS for each intervention arm compared with the WLC.

Intention to treat principles will be followed, using an original assigned group approach. All analyses will be done in R software with significance set at p < 0.05.

Group characteristics pre-intervention will be examined using Chi-squared and t-tests, and descriptive statistics will report recruitment, class attendance and program adherence. Free text reports, where provided, will be coded, categorised and emergent themes defined, and the number of responses per theme will be reported.

Differences between groups in PSS scores over time will be assessed using linear mixed models, fitted by maximum likelihood methods. Standardized mean difference (Cohen’s d) effect estimates will be reported. Secondary outcomes will be assessed in the same manner, and productive time, resource and AQoL data will be used to undertake an economic evaluation. Correlations between participant and informant reports will be examined.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/02/2018
Actual
Date of last participant enrolment
Anticipated
23/02/2018
Actual
Date of last data collection
Anticipated
28/06/2019
Actual
Sample size
Target
261
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 296463 0
University
Name [1] 296463 0
Australian Government Research Training Program Scholarship, University of Tasmania
Country [1] 296463 0
Australia
Funding source category [2] 296470 0
University
Name [2] 296470 0
TasNetworks Elite Mental Health and Wellbeing Scholarship, Menzies Institute for Medical Research, University of Tasmania
Country [2] 296470 0
Australia
Primary sponsor type
University
Name
Menzies Institute for Medical Research, University of Tasmania
Address
Private Bag 23
Hobart, Tasmania, 7000
Country
Australia
Secondary sponsor category [1] 295427 0
Government body
Name [1] 295427 0
Tasmanian State Service Management Office
Address [1] 295427 0
Tasmanian Government Department of Premier and Cabinet
GPO Box 123
Hobart Tasmania 7001
Country [1] 295427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297687 0
Tasmania Health and Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 297687 0
Ethics committee country [1] 297687 0
Australia
Date submitted for ethics approval [1] 297687 0
22/05/2017
Approval date [1] 297687 0
11/08/2017
Ethics approval number [1] 297687 0
H0016587

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

Contacts
Principal investigator
Name 74826 0
Dr Amanda Neil
Address 74826 0
C/- Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
Hobart Tasmania 7001
Country 74826 0
Australia
Phone 74826 0
+61 3 6226 4640
Fax 74826 0
Email 74826 0
[email protected]
Contact person for public queries
Name 74827 0
Larissa Bartlett
Address 74827 0
C/- Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
Hobart Tas 7001
Country 74827 0
Australia
Phone 74827 0
+61 3 6226 4723
Fax 74827 0
Email 74827 0
[email protected]
Contact person for scientific queries
Name 74828 0
Larissa Bartlett
Address 74828 0
C/- Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
Hobart Tas 7001
Country 74828 0
Australia
Phone 74828 0
+61 3 6226 4723
Fax 74828 0
Email 74828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo https://doi.org/10.2196/preprints.30272

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a Mindfulness App on Employee Stress in an Australian Public Sector Workforce: Randomized Controlled Trial.2022https://dx.doi.org/10.2196/30272
N.B. These documents automatically identified may not have been verified by the study sponsor.