Instructions For Use

Version 1.0 2023-07-10

Intended purpose of the ieso program

The ieso program is a software medical device accessed via a smartphone application designed to help adults experiencing symptoms of generalised anxiety, stress, and/or worry.

Please read these instructions for use carefully before using the ieso app and pay attention to the warnings around who should not use the ieso app below.

The program is based on principles from Cognitive-Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). It uses a variety of interactive activities, including videos, written psycho-educational content, AI conversational agents (“chatbots”), and in-program worksheets.

The ieso program is designed to alleviate symptoms of stress/anxiety/worry in people that may or may not have a formal anxiety related disorder. It does this by taking users through modules built on principles from evidence based psychotherapy techniques. The modules are designed to encourage exploration and education on difficulties experienced by the user, and to track mood and feelings through self-evaluation.

Using the ieso program

Who should use the ieso program?

People who:

are aged 18 and older, of any gender.
are experiencing difficulty with anxiety, worry and/or stress.
may be or may not be considering accessing therapy in the future.
may or may not have a diagnosis of generalised anxiety disorder and/or depression.

Do not use the ieso program if:

You are currently in, or recently have been in, a mental health crisis
You are at risk of harming yourself or others, or you have significant concerns about your own or someone else’s safety
You have symptoms or a diagnosis of a mental illness other than Generalised Anxiety Disorder or Depression, such as Post-Traumatic Stress Disorder (PTSD), Schizophrenia, Bipolar Disorder (BAPD), Obsessive-Compulsive Disorder (OCD), Personality Disorders or Eating Disorders (e.g., Anorexia Nervosa, Bulimia Nervosa or Binge-Eating).
Drug or alcohol use is problematic for you
You have been referred for psychiatric or neuropsychological assessment
You have any health conditions that impair your daily functioning that require intensive medical treatment
You are pregnant, or have recently been pregnant, as you may require specialist support
You are experiencing a significant impairment of cognitive function, such as dementia
You have been diagnosed with a neurodevelopmental condition
You require assisted technologies to communicate/type, due to the interactive nature of this device
Using this program is likely to delay or negatively impact engaging with future care

Installation

Download the ieso app from the Android or iOS app store on your smartphone.
Android - minimum Android 9 (API level 28); iOS - minimum version 15
An access code is required to use the app. Obtain the access code from your referring partner.
Launch the app and enter the access code when prompted.
Sign up by providing the necessary information and setting up your account.
Ensure you have an active internet connection to use the app.

How to use the ieso program (Operating instructions)

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, feelings, and behaviours 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 ask you a series of questionnaires at regular intervals, which can help you reflect on your mood and anxiety over time. They will not be used to provide any diagnostic information.

Undesirable side-effects

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. But it should not be an unpleasant experience, so pay attention to how you are feeling.
Spending large amounts of time on a smartphone can trigger headaches (or even migraines in those susceptible to them), so make sure to take breaks.
If you have any concerns about how the program is affecting you, please discontinue use, discuss this with your referring partner, or make use of the Further Support resources within the program.

Warnings and/or precautions

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 behaviours 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.
If you are having a very difficult time and say things which the program perceives as you having concerns about your own or someone else’s safety, it’s possible that the app will advise you to consider some other options for support.
If you develop any new symptoms throughout the course of the program, please understand that the app will not be able to manage them, so consult with a medical professional and report them as an incident as detailed below.

Incident Reporting

Please write to info@iesohealth.com if you have discovered a potential issue with this product. Note that any information submitted will be governed by our privacy policy. Alternatively, submit a complaint to complaints@iesohealth.com

Requesting a paper version of these instructions

If you would like to receive a paper version of this instruction document, please contact info@iesohealth.com

Manufacturing information