Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001005741
Ethics application status
Approved
Date submitted
1/07/2022
Date registered
18/07/2022
Date last updated
17/10/2022
Date data sharing statement initially provided
18/07/2022
Date results information initially provided
17/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Efficacy and Engagement of 'Hey Lemonade' App in Healthy Adults
Scientific title
Evaluation of Efficacy and Engagement of 'Hey Lemonade' App in Healthy Adults
Secondary ID [1] 307471 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being
 326862 0
Condition category
Condition code
Mental Health 324079 324079 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will evaluate the efficacy and usability of a mobile app targeted at every day stress that delivers short tailored motivational or inspirational talks.

The intervention period will last four weeks with participants randomized into one of the two research conditions. The Intervention Condition (N=60) will
- Use the Hey Lemonade app on an as-needed basis to reflect real world use conditions. Participants will watch short motivational and inspirational talks.
-Participants will watch short (2-3 min) motivational/inspirational videos delivered by voice actors and public figures discussing strategies to cope with everyday stressors when they encounter them. They can access and watch these as needed – there is no prescribed dose. For the trial, participants will have access for the full 4 weeks. Use of the app will be monitored using app analytics and identified through participant codes.
-Daily mood monitoring will be delivered by the Smartphone Ecological Momentary Assessment (SEMA) app and will take approximately 5 minutes per day.

The app currently has 30-40 uniquely written talks recorded by well-known voice actors or public figures such as Zoe Terakes, Susie Youssef, Dylan Alcott, Chief Brabon and Tony Armstrong.
Intervention code [1] 323927 0
Lifestyle
Comparator / control treatment
Control Condition (N=60): Control group will not use the Hey Lemonade app.
Daily mood monitoring will be conducted via an in-app study specific survey delivered via SEMA and will take approximately 5 minutes per day.
Control group
Active

Outcomes
Primary outcome [1] 331871 0
Change in coping self-efficacy as per the Coping self-efficacy scale (26 items)
Timepoint [1] 331871 0
week 0 (pre-intervention), week 4 (end of intervention)
Primary outcome [2] 331873 0
App engagement levels: number of interactions. Collected using app analytics.
Timepoint [2] 331873 0
Continuous, over the 4 weeks of app usage.
Primary outcome [3] 331874 0
App engagement levels: time per use. Collected using app analytics.
Timepoint [3] 331874 0
Continuous, over the 4 weeks of app usage.
Secondary outcome [1] 411452 0
Subjective wellbeing, Satisfaction with life scale (6 items).
Timepoint [1] 411452 0
week 0 (pre-intervention), week 4 (end of intervention)
Secondary outcome [2] 411453 0
Positive and Negative Affect Schedule (20 items)
Timepoint [2] 411453 0
week 0 (pre-intervention), week 4 (end of intervention)
Secondary outcome [3] 411454 0
Perceived Stress Scale (14 items)
Timepoint [3] 411454 0
week 0 (pre-intervention), week 4 (end of intervention)
Secondary outcome [4] 411455 0
Daily hassles and uplifts. Collected using a shortened version of the Delongis scale.. The original scale includes 53 hassles, and uplifts experienced over the previous day.
Timepoint [4] 411455 0
week 0 (pre-intervention), week 2 (mid-intervention), week 4 (end of intervention)
Secondary outcome [5] 411456 0
Hassles. Hassles will be assessed via a self-report measure of hassles derived from the Hassles Scale DeLongis, A., Folkman, S., & Lazarus, R. S. (1988). The impact of daily stress on health and mood: Psychological and social resources as mediators. Journal of Personality and Social Psychology, 54(3), 486–495. https://doi.org/10.1037/0022-3514.54.3.486
Timepoint [5] 411456 0
Continuous, over the 4 weeks of app usage. This will be captured daily using a version of the above survey modified based on a pilot trial in a contemporary, Australia setting.
Secondary outcome [6] 411457 0
Affect status. Participants will be asked to provide momentary ratings of their affect at each assessment point using an existing 6-item scale (Wilhelm and Schoebi 2007).
Timepoint [6] 411457 0
Continuous, over the 4 weeks of app usage. Participants will be reporting affect 2 times per day.
Secondary outcome [7] 411570 0
Primary outcome: App engagement levels: overall length of app interactions. Collected using app analytics.
Timepoint [7] 411570 0
Continuous, over 4 weeks of app usage.
Secondary outcome [8] 411571 0
Primary outcome: App evaluation: Page views for specific app components. Recorded using in app analytics.
Timepoint [8] 411571 0
Continuous, over 4 weeks of app usage.
Secondary outcome [9] 411572 0
Primary outcome: App evaluation: duration of engagement with video content. Recorded using in app analytics.
Timepoint [9] 411572 0
Continuous, over 4 weeks of app usage
Secondary outcome [10] 411573 0
The user evaluation (subjective feedback) will be tailored toward specific pages. "How useful was this feature?” “how easy was this feature to use?”

Participants will rate perceived usefulness on a Likert-type scale out of 7 with lower scores representing lower perceived usefulness and ease of use.
Timepoint [10] 411573 0
'Week 2 (2 weeks post-commencement of intervention, intervention half way point)
Secondary outcome [11] 411575 0
The user evaluation (subjective feedback) will be tailored toward specific pages. “How likely would you recommend this to a friend”

This will be asked on a 3 point fixed response with options yes, no, unsure.
Timepoint [11] 411575 0
'Week 2 (2 weeks post-commencement of intervention, intervention half way point)
Secondary outcome [12] 412267 0
Vitality, using Ryan and Frederick's Subjective Vitality Scale (7 items).
Timepoint [12] 412267 0
Week 0 (pre-intervention), week 4 (end of intervention)

Eligibility
Key inclusion criteria
• Aged 25-50 years old
• Own device suitable for installation of Hey Lemonade and SEMA app
• Residing in Australia
Minimum age
25 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Professionally diagnosed mental health condition
• Currently experiencing abnormal level of life stressors (self-reported)
• Less than 11 apps on their phone (low app engagement based on Google reports)

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)
Allocation will be concealed. Randomisation occurs centrally by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant characteristics will be presented descriptively. Covariates will be determined through analysis and correlation of descriptive data. Change in outcomes will be assessed using a two-group comparison controlling for any relevant covariates. This analysis will include completers only. Drop-out will be reported and compared across groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2022
Actual
16/08/2022
Date of last participant enrolment
Anticipated
1/05/2023
Actual
24/08/2022
Date of last data collection
Anticipated
31/05/2023
Actual
23/09/2022
Sample size
Target
120
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311748 0
Government body
Name [1] 311748 0
CSIRO
Country [1] 311748 0
Australia
Funding source category [2] 311749 0
Commercial sector/Industry
Name [2] 311749 0
Hey Lemonade
Country [2] 311749 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Public Health and Wellbeing
Gate 13 Kintore Ave
Adelaide sa 5000
Country
Australia
Secondary sponsor category [1] 313208 0
Individual
Name [1] 313208 0
Dr Emily Brindal
Address [1] 313208 0
CSIRO Public Health and Wellbeing
Gate 13 Kintore Ave
Adelaide sa 5000
Country [1] 313208 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311192 0
CSIRO Human Research Ethics
Ethics committee address [1] 311192 0
Gate 13 Kintore Ave, Adelaide SA 5000
Ethics committee country [1] 311192 0
Australia
Date submitted for ethics approval [1] 311192 0
18/07/2022
Approval date [1] 311192 0
04/08/2022
Ethics approval number [1] 311192 0

Summary
Brief summary
Background: The Hey Lemonade mobile app is in the development phase having attained initial seed investment to make the MVP (minimum viable product). The objective of the app is to tackle smaller mental health issues before they become bigger through the on demand delivery of situation-specific pep or motivational talks. The app contains a series of 2–3-minute talks designed to circuit break and help people alleviate common everyday stress. The content of the talks have been developed by the Hey Lemonade team in collaboration with professional writers and two clinical psychologists. The app developers have also drawn on design, user experience and user interface research to identify the most effective means of delivering the app content. The app currently has 30-40 uniquely written talks recorded by well-known voice actors or public figures such as Zoe Terakes, Susie Youssef, Dylan Alcott, Chief Brabon and Tony Armstrong.
Aims / Objectives:
While commercial mobile apps designed to promote health and well-being are becoming more and more popular, few are subject to rigorous testing to support the benefits they claim to deliver. The current project aims to quantify how engagement with the Hey Lemonade mobile app effects mood and stress in a real world setting as well as evaluate user experience. To do this the research team are proposing an uncontrolled two-arm randomized control trial recruiting participants identified by the Hey Lemonade app developers as their key demographic targets (women aged 25 – 50 years). Outcomes from the research would be used to refine the mobile app to maximize impact and usability.
Key Research question(s):
1. Does use of the Hey Lemonade app (intervention condition) result in a significant improvement in coping self-efficacy or well-being in users compared to participants who do not use the app (control condition)?
2. How do participants in the intervention condition engage with and rate the user features or functions of the Hey Lemonade app? This includes objective components such as page views for specific app components and any in-app ratings of this content. It may also include duration of interaction within these.
Hypothesis:
Use of the Hey Lemonade app results in improvement in mood and perceived stress levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120274 0
Dr Emily Brindal
Address 120274 0
CSIRO, Gate 13 Kintore Ave, Adelaide SA 5000
Country 120274 0
Australia
Phone 120274 0
+61 08 8305 0633
Fax 120274 0
Email 120274 0
Emily.Brindal@csiro.au
Contact person for public queries
Name 120275 0
Dr Emily Brindal
Address 120275 0
CSIRO Gate 13 Kintore Ave, Adelaide SA 5000
Country 120275 0
Australia
Phone 120275 0
+61 08 8305 0633
Fax 120275 0
Email 120275 0
Emily.Brindal@csiro.au
Contact person for scientific queries
Name 120276 0
Dr Emily Brindal
Address 120276 0
CSIRO Gate 13 Kintore Ave, Adelaide SA 5000
Country 120276 0
Australia
Phone 120276 0
+61 08 8305 0633
Fax 120276 0
Email 120276 0
Emily.Brindal@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be made available – all data will only be shared at group level due to commercial sensitivities


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.