Instructions for Use

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What is the ieso program?

It is a digital wellness program accessed via a smartphone application (or “app”). It is intended to help adults living well with anxiety, stress, and/or worry.

Using a self-guided method, users have access to six digital modules that incorporate principles from cognitive behavioral therapy (CBT) through a variety of interactive techniques, including conversational agents, videos, and in-program worksheets.

The modules are designed to encourage exploration and education on difficulties experienced by the user, and to track mood and feelings through self-evaluation.

Please read the instructions for use and safety information carefully before using this app, and only use it if it is, and remains at all times, suitable for you.

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Safety Information

As a mobile digital application providing self-guided tools and techniques that are intended to help you live well with anxiety, stress and/or worry, you might use the ieso program while considering whether to access some form of therapy or waiting for it to start. However, you should not use the ieso program if it is likely to delay or negatively affect utilization of future care.

The ieso program is not intended for diagnosis or treatment of a disease or condition, such as Generalized Anxiety Disorder or Major Depressive Disorder.

The ieso program is not intended for emergency use. If you are experiencing a mental health emergency or an acute mental health crisis, or including suicidal thoughts, you should call 911 or go to your nearest emergency room. The ieso program directs you to emergency resources, but these links do not raise an alert or start an emergency response. You can access the contact information for emergency resources at any time from this icon:

The program does not provide any live clinical oversight whilst you use the app or check your interactions with the app to determine if the program remains suitable for you.   If you access the emergency resources and wish to continue using the ieso program then you must check that the app remains suitable for you.   Should you continue to use the ieso program in those circumstances you are re-confirming that the app remains suitable for you.

The ieso program is not intended to be used instead of medical or mental health treatment. Do not make any changes to medications or treatment plans without consulting your healthcare provider.

This program will invite you to make changes both inside and outside of the sessions. Some of the changes (tasks) you will have the freedom to generate yourself. However, the app is unable to detect whether these behaviors are advisable or could cause harm to yourself or others. Therefore, it relies on the user (you) to be able to input tasks and goals that are unlikely to cause yourself or others harm in anyway.

As a digital wellness program, it is not intended to diagnose or treat, this program has not been evaluated by the Food and Drug Administration.

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Do not use this app if:

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• You are currently or have recently been having urges to harm yourself or someone else.
• You have current, untreated symptoms of a severe and persistent mental illness. For example: Post-Traumatic Stress Disorder (PTSD), Schizophrenia, Bipolar Disorder (BPD), Obsessive-Compulsive Disorder (OCD), or Personality Disorders
• You have an untreated eating disorder (e.g., Anorexia Nervosa, Bulimia Nervosa or Binge-Eating)
• You have untreated problems with drug or alcohol use.
• You require assisted technologies to communicate/type, due to the interactive nature of this device.
• You are experiencing a significant impairment of cognitive function, such as within the course of dementia.

Reflecting on your thoughts and facing your anxieties can be hard, so be aware that some of the questions that are asked in the program may be challenging for you. However, it should not be an unpleasant experience. If you are having a very difficult time and say things which could be perceived as increasing risk or danger to you or others, the ieso program may recommend that you consider other options for support.

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Installation and Operating Instructions

To install the ieso program:

1. Download the ieso app from the Android or iOS app store on your smartphone
2. An access code is needed to use the app (if you are eligible to use the app, an access code will have been     given to you)
3. Launch the app and enter the access code when prompted
4. Sign up by supplying the necessary information and setting up your account
5. Ensure you have an active internet connection to use the app.

The app is only supported on devices or operating systems meeting certain minimum technical requirements which are currently as follows:

·      an Apple device that runs iOS 16 as a minimum; or

·      an Android device that runs Android 13 and above as a minimum.

Once installed, follow the guided self-help program, engaging with the conversational agents and various activities provided within the app. You will be encouraged to reflect on your thoughts and give examples as part of the exercises. You will then get a chance to review what you have learnt and practice it over the length of the program.

The ieso program will intermittently ask you a series of questionnaires, which can help you reflect on your mood and anxiety over time. They are not to provide any diagnostic information.

Throughout the program, Artificial Intelligence (AI) is used to create amore personalized conversation for you. This involves using AI to understand what you’ve written and navigate the evidence-based content and workflows as well as to reference parts of your responses to demonstrate understanding and empathize with you. This technology has been developed with clinician oversight at all times and uses cutting-edge models and safety techniques to ensure a high quality of performance and safety.

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Changes to the Instructions for Use document

This version of the Instructions for Use document is Version EUT 1.0

The Instructions for Use document can be found on the ieso website.