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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]

Nil

Universal Trial Number (UTN)

U1111-1153-9539

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Emotion Regulation

Positive Mental Health

Wellbeing

Condition category

Condition code

Mental Health

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]

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]

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]

Baseline, 1 month post, 2 months post, 3 months post, 6 months post

Primary outcome [2]

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]

Baseline, 1 month post, 2 months post, 3 months post, 6 months post

Secondary outcome [1]

Nil

Timepoint [1]

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]

Charities/Societies/Foundations

Name [1]

Young and Well Collaborative Research Centre

Address [1]

Unit 17, 71 Victoria Crescent
Abbotsford, VIC, 3067

Country [1]

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]

Individual

Name [1]

Jessica Lewis

Address [1]

School of Psychology, The University of Queensland
McElwain Building
University of Queensland
St Lucia, QLD, 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

QUT Human Research Ethics Committee

Ethics committee address [1]

QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/10/2013

Approval date [1]

08/04/2014

Ethics approval number [1]

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

Dr Leanne Hides

Address

QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069

Country

Australia

Phone

+617 3138 6144

Fax

[email protected]

Contact person for public queries

Name

Leanne Hides

Address

QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069

Country

Australia

Phone

+617 3138 6144

Fax

[email protected]

Contact person for scientific queries

Name

Leanne Hides

Address

QUT
IHBI
60 Musk Ave
Kelvin Grove, QLD, 4069

Country

Australia

Phone

+617 3138 6144

Fax

[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.

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