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Trial registered on ANZCTR


Registration number
ACTRN12616000651482
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
19/05/2016
Date last updated
19/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Test of a mobile app to aid mindfulness and improve wellbeing in young people
Scientific title
Test of a mobile app for young people’s mindfulness – A randomised controlled trial
Secondary ID [1] 289206 0
None
Universal Trial Number (UTN)
U1111-1182-8423
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 298762 0
Mindfulness 298773 0
Distress 298774 0
Condition category
Condition code
Mental Health 298812 298812 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial uses an existing mindfulness app (Smiling Mind) which was identified as a high-quality app in a recent review*. The app is available for free on both Android and iOS platforms.

*Mani, M., Kavanagh, D. J., Hides, L., & Stoyanov, S. R. (2015). Review and evaluation of mindfulness-based iPhone apps. JMIR mHealth and uHealth, 3(3), e82.

The Smiling Mind app has a 10-week mindfulness program comprising 5-10 mins of voice-guided meditation for each week. The app recommends daily mindfulness practice for 2-7 days after each weekly session before proceeding with the next session.

Eligible participants are randomly allocated to Immediate access, Immediate access with Reminders or 6-week Delayed access to the Smiling Mind app. The immediate access groups will use the app upon completing the baseline survey while the wait-list controls will get the link to the app after 6-weeks. Participants will use the app for a period of 6 weeks. They won't be advised of frequency or duration of usage of the app. The Reminders group will receive weekly phone calls (lasting around 5 minutes) by the primary researcher to share their experience with the app and will be reminded about the importance of regular mindfulness practice.

Mental wellbeing, distress, mindfulness and happiness will be measured at baseline, 6, 12 and 18 weeks. App usage frequency will be collected by self-reports.
Intervention code [1] 294740 0
Prevention
Intervention code [2] 294786 0
Treatment: Devices
Comparator / control treatment
A waitlist control will be used for comparison. The app will be given to the waitlist controls 6 weeks later than the experimental groups.
Control group
Active

Outcomes
Primary outcome [1] 298282 0
Mental wellbeing (Mental Health Continuum - Short Form; MHC-SF)
Timepoint [1] 298282 0
Baseline
6 weeks (post intervention)
12 and 18 weeks (Follow Ups)
Secondary outcome [1] 323743 0
Distress (Kessler 10; K10)
Timepoint [1] 323743 0
Baseline
6 weeks (post intervention)
12 and 18 weeks (Follow Ups)
Secondary outcome [2] 323875 0
Mindfulness (Cognitive and Affective Mindfulness scale - Revised; CAMS-R)
Timepoint [2] 323875 0
Baseline
6 weeks (post intervention)
12 and 18 weeks (Follow Ups)
Secondary outcome [3] 323876 0
Happiness (Oxford Happiness Questionnaire; OHQ)
Timepoint [3] 323876 0
Baseline
6 weeks (post intervention)
12 and 18 weeks (Follow Ups)

Eligibility
Key inclusion criteria
Have access to iPhone or Android phone
At least mild level of distress (a score of at least 17 in Kessler-10 psychological distress scale)
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior mindfulness experience
Low distress
No access to an iPhone or Android phone

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293580 0
Charities/Societies/Foundations
Name [1] 293580 0
Young and Well Collaborative Research Centre
Address [1] 293580 0
Unit 17, 71 Victoria Crescent
Abbotsford, VIC, 3067
Country [1] 293580 0
Australia
Primary sponsor type
Individual
Name
Madhavan Mani
Address
Level 6, 62 Graham Street, South Brisbane, Queensland 4101.
Country
Australia
Secondary sponsor category [1] 292402 0
Individual
Name [1] 292402 0
Prof David Kavanagh
Address [1] 292402 0
Level 6, 62 Graham Street, South Brisbane, Queensland 4101.
Country [1] 292402 0
Australia
Secondary sponsor category [2] 292435 0
Individual
Name [2] 292435 0
A/Prof Leanne Hides
Address [2] 292435 0
Level 6, 62 Graham Street, South Brisbane, Queensland 4101.
Country [2] 292435 0
Australia
Secondary sponsor category [3] 292436 0
Individual
Name [3] 292436 0
Queensland University of Technology
Address [3] 292436 0
2 George St,
Brisbane,
QLD 4000.
Country [3] 292436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295027 0
QUT Human Research Ethics Committee
Ethics committee address [1] 295027 0
QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4059
Ethics committee country [1] 295027 0
Australia
Date submitted for ethics approval [1] 295027 0
30/06/2015
Approval date [1] 295027 0
13/07/2015
Ethics approval number [1] 295027 0
1400000827

Summary
Brief summary
There is now substantial evidence that mindfulness training improves wellbeing. Smartphones have become an integral part of young peoples’ daily life. Smartphone applications (apps) can potentially serve as an intervention medium to improve youth’s mental health. While there are many mobile phone apps on mindfulness, there is little evidence on the efficacy of these apps. The present study aims to evaluate the efficacy of a high qualtiy mindfulness app through a 6-week delayed treatment randomized controlled trial.

A sample of 150 young people who experience at least mild level of distress (scoring between 17 and 50 in Kessler 10) will be recruited for the trial. The primary outcome variable is wellbeing, measured by the Mental Health Continuum – Short Form (MHC-SF) and the secondary outcome variables are distress, measured by Kessler-10 (K10), mindfulness, measured by Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) and happiness, measured by Oxford Happiness Questionnaire - Short form (OHQ-SF). Outcomes will be assessed at baseline, 6, 12 and 18 weeks follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65502 0
Mr Madhavan Mani
Address 65502 0
Centre for Children’s Health Research (CCHR), Institute of Health & Biomedical Innovation (IHBI), QUT,
Level 6, 62 Graham Street, South Brisbane, Queensland 4101. Australia.
Country 65502 0
Australia
Phone 65502 0
+61 434 190 971
Fax 65502 0
Email 65502 0
m.mani@qut.edu.au
Contact person for public queries
Name 65503 0
Mr Madhavan Mani
Address 65503 0
Centre for Children’s Health Research (CCHR), Institute of Health & Biomedical Innovation (IHBI), QUT,
Level 6, 62 Graham Street, South Brisbane, Queensland 4101. Australia.
Country 65503 0
Australia
Phone 65503 0
+61 434 190 971
Fax 65503 0
Email 65503 0
m.mani@qut.edu.au
Contact person for scientific queries
Name 65504 0
Mr Madhavan Mani
Address 65504 0
Centre for Children’s Health Research (CCHR), Institute of Health & Biomedical Innovation (IHBI), QUT,
Level 6, 62 Graham Street, South Brisbane, Queensland 4101. Australia.
Country 65504 0
Australia
Phone 65504 0
+61 434 190 971
Fax 65504 0
Email 65504 0
m.mani@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary