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The Effect of Two Mobile Phone-based Applications on Mental and Physical Health of Individuals with Varying Activity Levels: A Randomized Controlled Trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001320549
Enrollment
85
Registered
2024-10-31
Start date
2025-08-01
Completion date
2025-10-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current study will examine the use of two mobile phone-based applications (Pi and Smiling Mind) that reportedly represent innovative approaches to mental health care. The aim of this study is to find out the impact of Pi app and Smiling Mind app on anxiety, resilience, and health related quality of life, which are key performance indicators in an exercise setting, using a sample of participants with varying physical activity levels against a waitlist control. The secondary aim is to find out how these apps can impact on psychosocial and physical health related factors.

Interventions

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

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.

Sponsors

ISN Psychology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026