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Trial registered on ANZCTR


Registration number
ACTRN12624001320549p
Ethics application status
Submitted, not yet approved
Date submitted
9/10/2024
Date registered
31/10/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Two Mobile Phone-based Applications on Mental and Physical Health of Individuals with Varying Activity Levels: A Randomized Controlled Trial
Scientific title
The Effect of Two Mobile Phone-based Applications (Pi App and Smiling Mind) on Mental and Physical Health of Individuals with Varying Activity Levels: A Randomized Controlled Trial
Secondary ID [1] 313150 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 335427 0
Health Related Quality of Life 335429 0
Condition category
Condition code
Mental Health 331986 331986 0 0
Anxiety
Mental Health 331987 331987 0 0
Other mental health disorders
Public Health 331988 331988 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a six-week digital intervention requesting at least 10 minutes a day of weekly participation in activities using the assigned mobile application (Smiling Mind or Pi app) and continue life as normal for the waitlist condition.

Pi App Intervention Group

Participants will be required to spend at least 10 minutes a day using the app. Some initial guidance will be provided on the app’s key features and functionalities that are critical to the intervention’s objectives.
The Pi App is a mobile application developed by Inflection, leveraging generative artificial intelligence (Gen AI) for mental health support. Key features include:

Personalized Experience: The app functions like a digital companion, offering users personalized interactions through voice and text. It simulates human-like conversation to provide mental health support.
Interactive Conversations: Users can engage with the app by typing or speaking queries, and the app responds with practical advice, information, or coping strategies. For example, a user might say, “I feel anxious about an upcoming event,” and the app could provide calming techniques or suggest stress management strategies.
Voice and Text Interactions: The app supports both voice and text-based communication, making it versatile for different user preferences.
Mental Health Support Prompts: The app can assist users in identifying and managing emotions, helping them relax or feel better in stressful situations. It also provides personalized suggestions based on the user's current mood or life circumstances, such as improving sleep, handling stress, or managing physical pain.

Example prompts related to mental and physical health will be provided such as follows:

Users can engage in conversations like:
“I’m feeling overwhelmed today. What should I do?”
“How can I relax before a stressful meeting?”
“Can you suggest ways to handle my anxiety during a workout?”

More general topics:
'Can you suggest ways to help me relax?'
'What can I do to feel better when I’m in pain?'
'How can I handle stress or difficult emotions?'
'What can I do to feel calmer during a stressful day?'
'How can I improve my sleep when I’m worried?'
'How can I stay comfortable when I’m feeling sore?' You can also ask about activities or habits that might help you feel better."
'How can I understand my mood better?'
'What small steps can I take to feel better today?'
'How do I stay positive when I’m not feeling my best?'

The participants will be required to self-report their usage of the app on a daily basis as well as complete short questionnaires pertinent to the primary outcome measures on a weekly basis.

Smiling Mind Intervention Group
Participants will be required to spend at least 10 minutes a day using the app in ways that suit their circumstances and age-group. The participants will be required to self-report their usage of the app on a daily basis as well as complete short questionnaires pertinent to the primary outcome measures on a weekly basis.

The Smiling Mind App is a mindfulness and meditation app designed by psychologists and educators to promote mental well-being. Key features include:

Structured Mindfulness Programs: It offers structured programs for different age groups, from children to adults, tailored to help manage stress, anxiety, and improve emotional resilience.
User Customization: The app allows users to customize their experience based on their circumstances, with options to select programs that fit their current emotional or mental state.
Age-Specific Content: The app offers specific programs tailored for children, adolescents, and adults, enabling users to find content most relevant to their age and needs.
Meditation and Relaxation Activities: Smiling Mind provides guided meditations, mindfulness exercises, and relaxation techniques.

Tailoring to Circumstances and Age Groups:

For children: Simple, short mindfulness practices are designed to help them manage emotions and focus.
For adults: Programs are more complex and include exercises for managing stress, reducing anxiety, and improving sleep quality.
Customizing based on activity: Users can choose sessions that suit their specific life context, such as managing work stress or preparing for a sporting event.


Exercise Settings Under Investigation
The exercise settings in this study involve participants with varying physical activity levels. These include:

Regular exercisers: Defined as those who engage in physical activity at least three days a week. This includes low, moderate, or high-intensity activities.
Non-exercisers: Individuals who do not regularly engage in physical activity.
The interventions will be administered in real-life settings where participants continue their normal physical activity routines while integrating the use of either the Pi or Smiling Mind app for mental health support.
For regular exercisers, this might involve using the apps before or after training sessions to help manage stress or improve focus. Non-exercisers would engage with the apps in their daily routines, with an emphasis on enhancing mental well-being.
Intervention code [1] 329721 0
Treatment: Other
Comparator / control treatment
Waitlist Groups
The waitlist control group will not receive any intervention and will continue with their usual daily activities without any changes. The participants will be required to complete short questionnaires pertinent to the primary outcome measures on a weekly basis.
Any participant experiencing psychological distress as a result of the participation in the study will be informed of the contact details of the chief investigator and third-party counselling services; Lifeline Australia Crisis Support (13 11 13; available 24-hours) and Beyond Blue (1300 224 636). They can also withdraw from the study at anytime as the participation is voluntary.
Control group
Active

Outcomes
Primary outcome [1] 339588 0
Anxiety
Timepoint [1] 339588 0
Week 0, 1, 2, 3, 4, 5, 6 post-intervention commencement, and optional 1-month follow-up post-intervention completion, etc.
Primary outcome [2] 339589 0
Resilience
Timepoint [2] 339589 0
Week 0, 1, 2, 3, 4, 5, 6 post-intervention commencement, and optional 1-month follow-up post-intervention completion, etc.
Primary outcome [3] 339590 0
Health Related Quality of Life
Timepoint [3] 339590 0
Week 0, 1, 2, 3, 4, 5, 6 post-intervention commencement, and optional 1-month follow-up post-intervention completion, etc.
Secondary outcome [1] 440530 0
Wellbeing
Timepoint [1] 440530 0
Week 0 and 6 post-intervention commencement, etc.
Secondary outcome [2] 440531 0
Worry
Timepoint [2] 440531 0
Week 0 and 6 post-intervention commencement, etc.
Secondary outcome [3] 440532 0
Mindfulness
Timepoint [3] 440532 0
Week 0 and 6 post-intervention commencement, etc.
Secondary outcome [4] 440533 0
Loneliness
Timepoint [4] 440533 0
Week 0 and 6 post-intervention commencement, etc.
Secondary outcome [5] 440534 0
Perceived Social Support
Timepoint [5] 440534 0
Week 0 and 6 post-intervention commencement, etc.

Eligibility
Key inclusion criteria
Inclusion Criteria
A participant of any gender
Aged 18 years or above
Currently living in Australia and plan on staying in Australia for the full length of this study.
Willing to be randomly allocated into one of three groups and further understand that it is essential to remain part of that group for the duration of the study even if it is not their preferred outcome.
English as their first language or University level English (If English was the participant’s first language, proficiency can be demonstrated by the past completion of a secondary or tertiary education in English. If English is not the participant’s first language, proficiency to be demonstrated by past sufficient score on a language skills test, such as an overall IELTS score of 6.5 with no band below 6.0).
Willingness for their data to be stripped off their identifying information and details placed on a public database such as the Open Science Framework (https://osf.io/).
Willing to be contacted by the researchers via email and mobile phone for the duration of the study.
Willing for their name and email address being shared with ISN Psychology Accounts Team for the purpose of reimbursement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
Clinically significant mental health conditions including mood disorders, psychotic conditions, clinical phobias, or persistent anxiety or depressive symptoms in a 2-week period than not (e.g. depressive disorders, anxiety disorders, schizophrenia disorders or psychosis).
Clinically significant physical health conditions or cardiac issues (physical injuries excepted).
Currently pregnant or have a suspected pregnancy.
Currently reporting any contraindications to exercise.

Participants were who are excluded for any of the above reasons will be provided with contact details for a third-part counselling service (e.g., Lifeline Australia Crisis Support; Beyond Blue). Furthermore, they can also contact the investigator whose details will be provided on the participant information sheet at the debriefing.

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)
Recruitment will occur in multiple waves as needed over 2025 until a target sample size of 150 participants is attained. Allocation will be single blinded and performed by a third party independent to the recruitment and enrolment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using the blockrand package in R statistical software (v. 3.6.1; R Core Team). A 1:1:1 ratio using random block sizes of 3 and 6 will be implemented.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Primary Outcome Measures

• Anxiety
• Resilience
• Health related Quality of Life

Main Research Question
R: Do the groups differ on the primary outcomes at week 6 (posttest) of the trial?

Hypotheses for Each Outcome Variable

Anxiety
H1a: Individuals allocated to Pi app will report lower anxiety at week 6 compared to those allocated to a waitlist control.
H2a: Individuals allocated to Pi app will report lower anxiety at week 6 compared to those allocated to Smiling Mind.
H3a: Individuals allocated to Smiling Mind will report lower anxiety at week 6 compared to those allocated to a waitlist control.

Resilience
H1b: Individuals allocated to Pi app will report higher resilience at week 6 compared to those allocated to a waitlist control.
H2b: Individuals allocated to Pi app will report higher resilience at week 6 compared to those allocated to Smiling Mind.
H3b: Individuals allocated to Smiling Mind will report higher resilience at week 6 compared to those allocated to a waitlist control.

Health Related Quality of Life
H1c: Individuals allocated to Pi app will report higher health related quality of life at week 6 compared to those allocated to a waitlist control.
H2c: Individuals allocated to Pi app will report higher health related quality of life at week 6 compared to those allocated to Smiling Mind.
H3c: Individuals allocated to Smiling Mind will report higher health related quality of life of Life at week 6 compared to those allocated to a waitlist control.

Statistical Analysis of Primary Outcome Measures
A pairwise comparison of the Week 6 (posttest) scores using the baseline scores (anxiety, resilience or health related quality of life, respectively), as covariates will be conducted using ANCOVA (i.e., a one-factor between-groups ANCOVA model). However, the main effect will not be reported as it is not of interest in this study. Any non-significant effect will be probed using equivalence tests. Equivalence bounds will be set at +/- .50. Equivalence will be tested using the TOST procedure.
The primary analysis will be an intention-to -treat analysis and an exploratory analysis will be conducted via a per-protocol analysis, where only participants who have used the apps for at least 10 minutes a day throughout the study for the whole duration of the 6-week program, will be retained for analysis at week 6.

Power Analysis
A priori power analysis using G* Power (Faul et al., 2007) was performed to estimate the minimum number of participants required to detect an effect of (d = 0.5) for posttest measures of anxiety, resilience, and health related quality of life between all pairwise comparisons. An effect size of d = 0.5 is often considered a moderate effect, in the context of psychological and behavioural research, as outlined by Cohen (1988). This size represents a moderate, meaningful difference between groups that is large enough to be of practical significance in most studies (Cohen, 1988). The Borm and colleagues (2007) equation (1 - r2) n, where r is the effect size and n is the sample size, will be used to compute the sample size with ANCOVA adjustment (Borm et al., 2007). The effect size from this calculation was used with the following input parameters: a = .05, allocation ratio = 1:1, power = .80, N = 144 (n1 = 48; n2 = 48; n3 = 48) Therefore, the total sample size needed to attain 80% of power in this study was estimated to be 144 participants with 48 participants in each group. Therefore, to round it off to even 50 in each group, 150 participants will be recruited.

Assumptions, Missing Data, and Outliers
Assumptions for one-factor between-groups ANCOVA will be assessed (e.g., linearity, normality, homogeneity of regression slopes, and homoskedasticity). Outliers will be visually inspected via the box plot rule. A sensitivity analysis will be conducted to observe any differences in the results in the presence and absence of outliers.

Missing data will be handled using multiple imputation, predictive mean matching to estimate missing data using an inclusive analysis approach (Newman, 2014). Information from auxiliary variables will be used to predict missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317593 0
University
Name [1] 317593 0
ISN Psychology
Country [1] 317593 0
Australia
Primary sponsor type
University
Name
ISN Psychology
Address
Country
Australia
Secondary sponsor category [1] 319901 0
None
Name [1] 319901 0
Address [1] 319901 0
Country [1] 319901 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316298 0
ISN Psychology Human Research Ethics Committee
Ethics committee address [1] 316298 0
Ethics committee country [1] 316298 0
Australia
Date submitted for ethics approval [1] 316298 0
24/09/2024
Approval date [1] 316298 0
Ethics approval number [1] 316298 0

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

Contacts
Principal investigator
Name 137438 0
Dr Guy Prochilo
Address 137438 0
ISN Psychology, R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street), Ivanhoe, Victoria, 3079
Country 137438 0
Australia
Phone 137438 0
+61 3900 81653
Fax 137438 0
Email 137438 0
gprochilo@isn.edu.au
Contact person for public queries
Name 137439 0
Guy Prochilo
Address 137439 0
ISN Psychology, R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street), Ivanhoe, Victoria, 3079
Country 137439 0
Australia
Phone 137439 0
+61 3900 81653
Fax 137439 0
Email 137439 0
gprochilo@isn.edu.au
Contact person for scientific queries
Name 137440 0
Guy Prochilo
Address 137440 0
ISN Psychology, R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street), Ivanhoe, Victoria, 3079
Country 137440 0
Australia
Phone 137440 0
+61 3900 81653
Fax 137440 0
Email 137440 0
gprochilo@isn.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data such as individual participant data of published results only, will be uploaded to the Open Science Framework for public dissemination
When will data be available (start and end dates)?
Following publication (available for 5 years after publication, etc.)
Available to whom?
Any individual who wishes to access it.
Available for what types of analyses?
Any type of analyses
How or where can data be obtained?
De-identified data will be stored to Open Science Framework. Web address to be determined. However, for any inquiries regarding data the Principal Investigator can be contacted in the interim:
Dr. Guy Prochilo
T (03) 9008 1653
A Ivanhoe Offices, R5/443 Upper Heidelberg Road, Ivanhoe, 3079
E gprochilo@isn.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24261Statistical analysis plan    Described under the statistical analysis
24262Analytic code    Will be made available to the Open Science Framewo... [More Details]



Results publications and other study-related documents

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