Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001155987
Ethics application status
Approved
Date submitted
27/07/2020
Date registered
4/11/2020
Date last updated
4/11/2020
Date data sharing statement initially provided
4/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the impact of Smiling Mind App programs on the well-being of adult participants?
Scientific title
Investigating the impact of access to the Smiling Mind app for naive adult users on levels of stress, sleep quality, and relationship outcomes, as compared to a wait list-controlled group.
Secondary ID [1] 301884 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 318388 0
Stress 318389 0
Loneliness 318390 0
Condition category
Condition code
Public Health 316404 316404 0 0
Health promotion/education
Mental Health 316405 316405 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Smiling Mind app targets three primary areas of daily functioning: stress reduction, increase sleep quality, and reduced loneliness. The users are able to choose which program (or all) they would like to register for.
Once participants complete the consent form and baseline assessment (via online platform: REDcap), they will be randomised in to one of two conditions: waitlist/control group, or app treatment group. Respondents randomised to the app treatment group get sent an email with instructions on how to download and get started with the programs (of their choice).
The activities in the app includes audio guided meditations, which the participants are encouraged to engage with every day, however, the minimum number of meditations required is five over two weeks. The intervention duration is four weeks in total, with the baseline assessment given to participants at two weeks and four weeks.
Before the two- and four-week assessments are sent to participants in the treatment group, research team members from Smiling Mind (listed and approved on ethics) will check the registration and engagement in the app via the email address provided by the participant.
Participants allocated to the waitlist/control group will be asked to declare any engagement in mindfulness meditation at the beginning of the two- and four-week online surveys. Declaration of engagement deems them ineligible to continue with the project.
All participants who complete all three assessments go into the draw to win a $100 Amazon voucher, emailed to them at the conclusion of the project.
Intervention code [1] 318174 0
Lifestyle
Intervention code [2] 318175 0
Treatment: Other
Comparator / control treatment
The control/waitlist group will be 50% of the trial participants and will be given access to the Smiling Mind mindfulness application after the four weeks of the research study. The waitlist group will complete intermittent and four-week online assessments (same as the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 324557 0
Change stress scores, as measured by the Short Stress Overload Scale (SOS-short).
Timepoint [1] 324557 0
This will be measured at both the intermittent (2-week) and conclusion (4-week) assessments.
Secondary outcome [1] 384969 0
Change in sleep quality score as measured by the Sleep Disturbance Scale (SDS).
Timepoint [1] 384969 0
This will be measured at both the intermittent (2-week) and conclusion (4-week) assessments.
Secondary outcome [2] 387481 0
Change in loneliness score as measured by the UCLA loneliness scale.
Timepoint [2] 387481 0
This will be measured at both the intermittent (2-week) and conclusion (4-week) assessments.
Secondary outcome [3] 388447 0
Change in mindfulness scores, as measured by the five facet mindfulness questionnaire (FFMQ)
Timepoint [3] 388447 0
Baseline, 2 weeks (intermittent), and 4 weeks (conclusion)

Eligibility
Key inclusion criteria
Over 18 years old,
Australian resident,
English speaking,
Regular access to a smart phone with internet access,
Self-declared good physical and mental health, with no previous (within the past 3 years) or current diagnosis of a psychiatric illness such as depression or anxiety.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age,
Non-English speaking,
No smartphone with internet access,
A diagnosis of a psychiatric illness within the previous three years,
Having practiced mindfulness previously

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)
The randomisation model is completed by a statistician who is not involved in the recruitment or analysis of data for this project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed using an excel spreadsheet which will be uploaded to a researcher specific survey collection database (REDcap).
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
200 participants to complete the baseline survey (100 in each group) to retain 62 per group at follow-up to detect a moderate effect size difference between groups on the stress scale at follow-up assessment. This accounts for a 35% attrition rate.

The outcomes will be tested using ANOVA and if appropriate ANCOVA (i.e. if one or demographic variables have an influence on the participant outcomes). Descriptives and frequencies will also be analysed to test differences between groups within each treatment condition.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306304 0
Charities/Societies/Foundations
Name [1] 306304 0
NIB Foundation
Country [1] 306304 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 306797 0
Commercial sector/Industry
Name [1] 306797 0
Smiling Mind
Address [1] 306797 0
55 Cromwell St, Collingwood VIC 3066
Country [1] 306797 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306519 0
University of Newcastle's Human Research Ethics Committee (HREC)
Ethics committee address [1] 306519 0
University Drive, Callaghan, NSW, 2308.
Ethics committee country [1] 306519 0
Australia
Date submitted for ethics approval [1] 306519 0
29/05/2020
Approval date [1] 306519 0
24/07/2020
Ethics approval number [1] 306519 0
H-2020-0198

Summary
Brief summary
This study is a randomised controlled trial, comparing the participation in a Smiling Mind program with a waitlist/control group. Participants will be recruited through facebook and will be given the participation information statement outlining the research. Those agreeing to participate will be redirected to the initial survey (baseline data collection) which will be generated through REDcap survey software. Once the survey is complete participants will be
randomised to either the waitlist/control group, or participation in a Smiling Mind program of their choice (sleep, relationships, or stress). Participants allocated to the waitlist group will receive an email with detailing that they will need to wait to join the program. Participants allocated to participate in the program will be sent instructions for joining the program. Participants will be asked to complete the initial survey (minus questions asking about
demographics, and their experience with mindfulness practice) at two more time points: two weeks (half way), and four weeks (conclusion of the program).
The data collected from the surveys at each time-point will be analysed to assess if there is a difference between the experimental and control groups. As an incentive to complete follow up surveys participants who complete all of the surveys will go in the draw win one $100 Amazon gift voucher. Throughout the study the Smiling Mind team will monitor using participant email addresses provided at baseline whether intervention participants have downloaded the application and are participating. If after 5 days participants have not downloaded the app and started engaging in the program, then the University of
Newcastle team will send an email reminder. The email address will also be used to match participant responses between surveys. The data collected from interventions application usage will also be analysed to determine patterns of usage and engagement.
It is hypothesised that participants who engage in the Smiling Mind program will have significantly improved well-being in comparison to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104142 0
Prof Frances Kay-Lambkin
Address 104142 0
University of Newcastle, Faculty of Medicine and Public Health
Level 5, McAuley Center, Calvary Mater Hospital, Waratah, NSW 2298
Country 104142 0
Australia
Phone 104142 0
+61 422 620 385
Fax 104142 0
Email 104142 0
[email protected]
Contact person for public queries
Name 104143 0
Mrs Jessica Wilson
Address 104143 0
University of Newcastle, Faculty of Medicine and Public Health
Level 5, McAuley Center, Calvary Mater Hospital, Waratah, NSW 2298
Country 104143 0
Australia
Phone 104143 0
+61 422620385
Fax 104143 0
Email 104143 0
[email protected]
Contact person for scientific queries
Name 104144 0
Mrs Jessica Wilson
Address 104144 0
University of Newcastle, Faculty of Medicine and Public Health
Level 5, McAuley Center, Calvary Mater Hospital, Waratah, NSW 2298
Country 104144 0
Australia
Phone 104144 0
+61 422 620 385
Fax 104144 0
Email 104144 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


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.