Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001113943
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
28/10/2020
Date last updated
28/10/2020
Date data sharing statement initially provided
28/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effect of an online mindfulness app on workplace-associated psychological and physiological stress levels of direct care workers in rural Australian aged care
Scientific title
Examination of the effect of an online mindfulness app on workplace-associated psychological and physiological stress levels and the retention of direct care workers in rural Australian aged care
Secondary ID [1] 302073 0
None
Universal Trial Number (UTN)
U1111-1257-1638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
workplace stress 318671 0
Condition category
Condition code
Public Health 316689 316689 0 0
Health service research
Public Health 317032 317032 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to engage in a 3-week mindfulness program delivered via a smartphone application (app), Smiling Mind (smilingmind.com.au). Smiling Mind is a free app available to download on iOS and Android devices and is accessible online. The app includes a variety of programs comprising of mindfulness meditations and activities ranging in duration from 1-45 minutes. For this study, participants will engage in the Healthcare Workers Program. The Healthcare Workers app was designed with easy to access information, resources and activities, developed to support users to “manage stress, improve focus and performance, and cultivate connection and resilience” (smilingmind.com.au). The Healthcare Workers Program contains 8 modules: Introduction – What is Mindfulness, Mindfulness Foundations, Managing Stress, Sleep, Thinking Clearly, Connection, Resilience, and Extending your Mindfulness Practice. The modules comprise of a total 51 sessions, 5 educational (e.g., What is mindfulness, Stress management), 8 activity (e.g., Exploring the breath, Journaling exercise), and 38 guided meditation (e.g. Body scan, Brain break) sessions. The majority of the in-app sessions are audio delivered, with some video and text delivered sessions. Participants will be asked to engage in guided mindfulness meditation for approximately 15 minutes three times a week for 3 weeks. Participants will be asked to complete and record a brief daily log of activities.’recording only the number of minutes spent using the app. To monitor adherence to the intervention, usage data (mins.) will be obtained from Smiling Mind (with participant permission).
Intervention code [1] 318371 0
Treatment: Other
Comparator / control treatment
The trial will use a waitlist control group. Participants will be allocated to one of two groups: immediate treatment group (ITG) or the waitlist control group (WCG). The ITG will immediately begin the intervention using the mindfulness application for three weeks. At the end of the three weeks, the WCG will crossover to the intervention arm and use the application for three weeks.
Control group
Active

Outcomes
Primary outcome [1] 324817 0
The primary measure of workplace stress as assessed by the Effort-Reward Imbalance Questionnaire (ERI-Q; Siegrist, 1996).
Timepoint [1] 324817 0
pre-intervention, post-intervention immediately following 3-week intervention (primary endpoint), 8 weeks post-intervention
Primary outcome [2] 324819 0
Changes in intentions to leave the job as assessed by the Turnover Intention Scale (TIS-6; Bothma & Roodt, 2013);
Timepoint [2] 324819 0
pre-intervention, post-intervention immediately following 3-week intervention (primary endpoint), 8 weeks post-intervention
Primary outcome [3] 324820 0
Changes in pre-clinical markers of ill-health as assessed by the concentration levels of salivary cortisol, salivary alpha amylase (sAA) and secretory immunoglobulin A (sIgA).
Timepoint [3] 324820 0
Timepoint: pre-intervention, post-intervention immediately following 3-week intervention (primary endpoint), 8 weeks post-intervention
Secondary outcome [1] 385845 0
Changes in levels of trait mindfulness as assessed by Freiburg Mindfulness Inventory - Short Form (FMI; Walach, Buchheld, Buttenmüller, Kleinknecht, & Schmidt, 2006)
Timepoint [1] 385845 0
pre-intervention, post-intervention immediately following 3-week intervention , 8 weeks post-intervention
Secondary outcome [2] 387165 0
Changes in levels of chronic stress as assessed by the Perceived Stress scale
Timepoint [2] 387165 0
baseline, immediately post 3-week intervention, 8 weeks post intervention
Secondary outcome [3] 387166 0
Changes in levels of mebtal and physical health as assessed by the Short Form General Health Questionairre
Timepoint [3] 387166 0
baseline, immediately post 3-week intervention, 8 weeks post intervention
Secondary outcome [4] 387167 0
workplace stress as assessed by the Job-Demands Resources Questionairre
Timepoint [4] 387167 0
baseline, immediately post 3-week intervention, 8 weeks post intervention

Eligibility
Key inclusion criteria
Participants will need to be over 18 years in age, employed in aged care, working primarily in a direct-care role. Participants will be required to be working a minimum of 20 hours per week and have been employed for at least three months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals using hormone replacement therapy will be asked to self-exclude from the study as these medications can confound the physiological measures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss to decide which centres go in intervention and waiting list 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
Efficacy
Statistical methods / analysis
A power analysis using G*Power 3 revealed that with an f2 = .45 effect size for the largest 2 x 3 ANCOVA model a minimum of 29 participants per group (waitlist control vs experimental) was required to achieve a statistical power of .80.
IBM SPSS statistics computer package (Version 23.0) will be used for statistical analysis.
Analysis of enduring effects of the mindfulness application: A series of repeated measures ANCOVAs will be used to assess if using the mindfulness application for 3 weeks had improved workplace stress (ERI, JDR), chronic stress, physical and mental health, trait mindfulness, turnover intentions, and physiology, after controlling for active participation in the mindfulness program. The ANCOVAs with physiological outcomes will also include the covariate of adherence to the saliva protocol.
Assessing the impact of improved mindfulness: A series of mediated regressions with 5000 bootstrap resamples will be conducted using the SPSS PROCESS macro as outlined by Hayes (2013) to assess if changes in mindfulness mediate the association between changes in workplace stress (ERI, JDC) with physiology, and job-turnover intentions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2020
Date of last participant enrolment
Anticipated
7/11/2020
Actual
Date of last data collection
Anticipated
28/12/2020
Actual
Sample size
Target
60
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30994 0
3699 - Mount Beauty
Recruitment postcode(s) [2] 30992 0
3700 - Tallangatta
Recruitment postcode(s) [3] 30995 0
3737 - Myrtleford
Recruitment postcode(s) [4] 30993 0
3747 - Beechworth

Funding & Sponsors
Funding source category [1] 306491 0
University
Name [1] 306491 0
La Trobe University
Country [1] 306491 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd Bundoora, VIC, 3083
Country
Australia
Secondary sponsor category [1] 307016 0
None
Name [1] 307016 0
Address [1] 307016 0
Country [1] 307016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306697 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 306697 0
Plenty Rd Bundoora, VIC 3083
Ethics committee country [1] 306697 0
Australia
Date submitted for ethics approval [1] 306697 0
13/07/2020
Approval date [1] 306697 0
14/08/2020
Ethics approval number [1] 306697 0
HEC19183

Summary
Brief summary
The project will examine workplace stress experienced by aged care workers. The experience of stress may cause physiological changes in immune and hormonal systems, and these changes can affect our mental and physical health. The project aims to extend the knowledge of the relationship between workplace stress, turnover intentions, and physiological markers of stress: salivary cortisol, salivary alpha-amylase (sAA), and secretory immunoglobulin A (sIgA). Using a waitlist control design, participants will engage with a mindfulness smartphone intervention for three weeks. It will establish the relationships between mindfulness, stress and pre-clinical markers of diease. Participants will provide saliva samples and complete questionnaires at three time-points: pre-intervention, post-intervention, and 2-months post-intervention. This information is important as it will improve our understanding of the effects of workplace stress on the immune and hormonal systems and self-reported intentions to leave a vocation..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104706 0
Dr Bradley Wright
Address 104706 0
School of Psychology and Public Health
La Trobe University
Plenty Rd,
Bundoora, VIC 3086
Country 104706 0
Australia
Phone 104706 0
+61 394792348
Fax 104706 0
Email 104706 0
b.wright@latrobe.edu.au
Contact person for public queries
Name 104707 0
Bradley Wright
Address 104707 0
School of Psychology and Public Health
La Trobe University
Plenty Rd,
Bundoora, VIC 3086
Country 104707 0
Australia
Phone 104707 0
+61 394792348
Fax 104707 0
Email 104707 0
b.wright@latrobe.edu.au
Contact person for scientific queries
Name 104708 0
Bradley Wright
Address 104708 0
School of Psychology and Public Health
La Trobe University
Plenty Rd,
Bundoora, VIC 3086
Country 104708 0
Australia
Phone 104708 0
+61 394792348
Fax 104708 0
Email 104708 0
b.wright@latrobe.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?




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.