Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000051549
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
22/01/2015
Date last updated
10/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a new iPhone Mood Management Application
Scientific title
Does the mobile phone app 'Music eScape' promote positive mental health and wellbeing in young people?
Secondary ID [1] 284267 0
Nil
Universal Trial Number (UTN)
U1111-1153-9539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion Regulation 291389 0
Positive Mental Health 291390 0
Wellbeing 291391 0
Condition category
Condition code
Mental Health 291753 291753 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Young people will be invited to use a new music and emotion based mobile phone application 'Music eScape' over a 1 month period. Participants' emotional identification and regulation, wellbeing and involvement in music will be measured before and after using the application.

The "Music eScape" application automatically tags the user's music library with moods. Users can draw a 'musical journey' through moods by identifying how they are currently feeling and how they would like to feel. Thus the application generates an automated playlist aiming to take the user through the chosen moods by using music.
Intervention code [1] 288974 0
Other interventions
Comparator / control treatment
A wait list control will be used whereby 50% of the sample will be provided the mobile phone application one month later than the experimental cohort.
Control group
Active

Outcomes
Primary outcome [1] 291688 0
Develop an understanding of emotion regulation and the impact this has on mental health and wellbeing in young people based on participants use of the eScape app and self reports of the success of the app assisting them to reach their target mood as well as on wellbeing and emotion regulation measures including the Difficulties in Emotion Regulation Scale (DERS), K10, Flourishing Scale, Mental Health Continuum Short Form (MHC-SF) and Satisfaction with Life Scale (SWLS)
Timepoint [1] 291688 0
Baseline, 1 month post, 2 months post, 3 months post, 6 months post
Primary outcome [2] 291689 0
Develop an understanding of the use of music and technology to promote positive mental health and wellbeing in young people based on participants use of the eScape app and self reports of their experience of using the mobile application, the success of the app assisting them to reach their target mood as well as on wellbeing and emotion regulation measures including the DERS, K10, Flourishing Scale, MHC-SF, and SWLS
Timepoint [2] 291689 0
Baseline, 1 month post, 2 months post, 3 months post, 6 months post
Secondary outcome [1] 307290 0
Nil
Timepoint [1] 307290 0
Nil

Eligibility
Key inclusion criteria
1. Aged 17-25 years
2. Have normal hearing
3. Have access to an iPhone 4 or later model
4. Experiencing mild levels of stress/distress
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have a hearing impairment
2. Do not have access to an iPhone 4 or later model
3. Not experiencing mild levels of stress/distress

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Half of the sample will be randomly allocated to a wait list control group. These participants will act as a control for themselves (one month without the intervention vs one month with the intervention) and for the immediate access group (effect of intervention vs no intervention over a one month period).
Phase
Type of endpoint/s
Statistical methods / analysis
Earlier, similarly structured research conducted by the same team has used samples of this size to observe outcomes in similar variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2014
Actual
9/09/2014
Date of last participant enrolment
Anticipated
Actual
23/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288889 0
Charities/Societies/Foundations
Name [1] 288889 0
Young and Well Collaborative Research Centre
Country [1] 288889 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Young and Well Collaborative Research Centre
Address
Unit 17, 71 Victoria Crescent
Abbotsford, VIC, 3067
Country
Australia
Secondary sponsor category [1] 287586 0
Individual
Name [1] 287586 0
Jessica Lewis
Address [1] 287586 0
School of Psychology, The University of Queensland
McElwain Building
University of Queensland
St Lucia, QLD, 4072
Country [1] 287586 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290718 0
QUT Human Research Ethics Committee
Ethics committee address [1] 290718 0
QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4059
Ethics committee country [1] 290718 0
Australia
Date submitted for ethics approval [1] 290718 0
24/10/2013
Approval date [1] 290718 0
08/04/2014
Ethics approval number [1] 290718 0
1300000803

Summary
Brief summary
This study will evaluate the usability, acceptability and impact of the Music eScape application and it’s capacity to promote wellbeing in young people. The eScape app is designed for users to identify their current and desired mood states and produce a playlist of mood-tagged music from their own music library that will help them achieve this.

Prototype testing will be conducted to inform the development of the Music eScape app. Two groups of five participants will each be asked to complete a 30 minute survey, then attend a focus group to explore the mobile application and test it’s functionality.

We are then seeking young people who experience at least mild levels of stress/distress to test the music-based mobile phone application. Young people will complete a brief 10-item screen questionnaire to determine their eligibility for participating in the study. 180 participants who report at least mild levels of stress/distress in the past month will be recruited for the outcome evaluation. Participants will be asked to complete an online survey, which will include questionnaires addressing emotion identification and regulation, wellbeing and involvement in music.

Half of the participants will be asked to download the free eScape app on their mobile devices and trial it for one month (referred to as the immediate access group), while logging in their current and target moods, along with the success rate of the application in assisting them to reach their target mood. During their use of the application, details of app usage (e.g., number of times used, duration of use, features used) will be recorded and automatically downloaded. Participants will be followed up at the end of their one month of app use, and again two, three and six months later to complete online surveys addressing emotion regulation, wellbeing and their experience of using the mobile application. Participants will receive 4 SMS’s over their initial first month of app use to remind them to use the app.

The remaining half will comprise a waitlist control, whose access to the application will be delayed by one month. Delayed app access provides a control group for comparison of mood regulation in absence of any intervention. Waitlisted participants will receive up to 4 SMS’s to minimise participant attrition. After this month, their involvement will replicate that of the immediate access group, outlined above.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46954 0
Dr Leanne Hides
Address 46954 0
QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069
Country 46954 0
Australia
Phone 46954 0
+617 3138 6144
Fax 46954 0
Email 46954 0
[email protected]
Contact person for public queries
Name 46955 0
Dr Leanne Hides
Address 46955 0
QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069
Country 46955 0
Australia
Phone 46955 0
+617 3138 6144
Fax 46955 0
Email 46955 0
[email protected]
Contact person for scientific queries
Name 46956 0
Dr Leanne Hides
Address 46956 0
QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069
Country 46956 0
Australia
Phone 46956 0
+617 3138 6144
Fax 46956 0
Email 46956 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.