Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001001583
Ethics application status
Approved
Date submitted
4/09/2015
Date registered
25/09/2015
Date last updated
10/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the usability, acceptability and impact of a gamification/mindfulness etool for young people
Scientific title
Evaluating the usability, acceptability and impact of a gamification/mindfulness e-tool for young people
Secondary ID [1] 286472 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The experience of stress & distress in young people. 294660 0
Condition category
Condition code
Mental Health 294961 294961 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Gamified and Non-Gamified version of the Mindfulness etool will be evaluated by young Australians (16 -25) who have regular access to a computer or smartphone, and are experiencing at least a mild to moderate level of distress. The outcome variables, psychological distress, emotional and psychological wellbeing, mindful attention awareness and frequency of mindful behaviours, will be assessed at baseline and at 6, 12 and 24 weeks follow-up for all participants.

The mindfulness e-tool will be in the form of an existing website ("Smiling Mind"), which has been adapted for gamification for some participants. Gamified elements include earning points and badges and accessing new levels. For non-gamified users, the existing mindfulness audio exercises and information will be available.

The mindfulness exercises available to all participants are audio exercises which guide participants through meditation, breathing exercises, body scans and other techniques which are designed to increase mindfulness. Mindfulness has been shown to alleviate symotoms of depression, stress, anxiety, addiction and to improve wellbeing.

Participants in the Gamification Mindfulness group and Non-Gamification Mindfulness group will be asked to trial one of two versions of the Mindfulness etool for 6 weeks. During this time data will be collected about the use of the Mindfulness etool (including the number of times it was used; the date, time and duration of each session of use; and the sections of the website accessed and data entered). Participants will also be requested to provide feedback on the objective and subjective quality and acceptability of the etool after 6 weeks of use and again at each follow-up.

Participants will be able to access the etool as many times as they want within the 6 week period after receiving access. Once receiving access participants will receive weekly SMS/email reminders to use the etool.
Intervention code [1] 291560 0
Treatment: Other
Comparator / control treatment
Delayed-acess control group: one third of participants will be randomly allocated to a wait-list control, and will receive access to the gamified version of the mindfulness etool after the 6 week follow up.
Control group
Active

Outcomes
Primary outcome [1] 294717 0
Psychological distress. This will be assessed by the Kessler
Psychological Distress Scale (K10)
Timepoint [1] 294717 0
Baseline, 6, 12, 24 weeks follow-up
Primary outcome [2] 294718 0
Emotional and psychological wellbeing. This will be assessed by the Mental Health Continuum Short Form (MHC-SF).
Timepoint [2] 294718 0
Baseline, 6, 12, 24 weeks follow-up
Primary outcome [3] 294719 0
Mindfulness. A combination of questions from the Kentucky Inventory of Mindfulness Scale (KIMS) and the Five Facet Mindfulness Questionnaire (FFMQ) will be used, as well a the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Timepoint [3] 294719 0
Baseline, 6, 12, 24 weeks follow-up
Secondary outcome [1] 313925 0
The navigation, aesthetics, information quality, engagement, purpose, aim and satisfaction with the Mindfulness etool. Assessed using an 18-item Mobile Application Rating Scale (MARS) adapted for a website. This is a composite secondary outcome.
Timepoint [1] 313925 0
6 week follow-up

Eligibility
Key inclusion criteria
1. Aged 16 - 25 years
2. Experience mild to moderate levels of distress
3. Have regular access to a computer or smartphone
4. Have not extensively engaged in Mindfulness activities in the recent past
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Do not experience mild level of distress
2. Do not have regular access to a computer or smartphone
3. Have engaged in regular or recent mindfulness practice

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
3/07/2015
Date of last participant enrolment
Anticipated
Actual
24/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291988 0
Other Collaborative groups
Name [1] 291988 0
Young and Well Cooperative Research Centre
Country [1] 291988 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Young and Well Cooperative Research Centre
Address
Unit 17, 71 Victoria Crescent
Abbotsford VIC 3067
Country
Australia
Secondary sponsor category [1] 290652 0
None
Name [1] 290652 0
Address [1] 290652 0
Country [1] 290652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293479 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 293479 0
Ethics committee country [1] 293479 0
Australia
Date submitted for ethics approval [1] 293479 0
Approval date [1] 293479 0
28/04/2015
Ethics approval number [1] 293479 0

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

Contacts
Principal investigator
Name 56278 0
A/Prof Daniel Johnson
Address 56278 0
Science and Engineering Faculty
Queensland University of Technology
Gardens Point
Brisbane QLD 4000
Country 56278 0
Australia
Phone 56278 0
+61 7 3138 9263
Fax 56278 0
Email 56278 0
[email protected]
Contact person for public queries
Name 56279 0
Daniel Johnson
Address 56279 0
Science and Engineering Faculty
Queensland University of Technology
Gardens Point
Brisbane QLD 4000
Country 56279 0
Australia
Phone 56279 0
+61 7 3138 9263
Fax 56279 0
Email 56279 0
[email protected]
Contact person for scientific queries
Name 56280 0
Daniel Johnson
Address 56280 0
Science and Engineering Faculty
Queensland University of Technology
Gardens Point
Brisbane QLD 4000
Country 56280 0
Australia
Phone 56280 0
+61 7 3138 9263
Fax 56280 0
Email 56280 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.