Regulatory Information

Last updated 4th July 2022

APP NAME: RESONY

VERSION NO: 1.0.2

Intended Use

Resony is a digital therapeutic intended for the improvement of worry and anxiety and management of Generalised Anxiety Disorder (GAD) in adults aged 18 years and older, as an adjunct to their usual medical care.

For adults diagnosed with GAD, Resony should be used under the supervision of a healthcare professional. For adults with worry, anxiety and stress, Resony may be used as a non-prescription self-management tool to improve mental health and wellbeing.

Resony is a fully automated digital program to improve worry, anxiety and help people reduce stress and build resilience. The program is based on psychotherapeutic techniques from cognitive behavioural therapy (CBT) and mindfulness. The program also includes physiological techniques from applied relaxation, breathing exercises, binaural beats audio and heart rate variability training.  These techniques have been shown to be effective in helping many people reduce their worry, anxiety and stress. These techniques may reduce physical and psychological symptoms such as inability to relax, fatigue, trouble sleeping, muscle tension or muscle aches, trembling, feeling twitchy, nervousness or being easily startled, sweating, nausea, and diarrhoea.

Warnings and Precautions

Resony must not be used by the following:

• People suffering with severe GAD

• People suffering with severe depression with and without risk of self harm

• People suffering with uncontrolled symptoms of schizophrenia, bipolar disorder and severe obsessive-compulsive disorder, panic disorder, and dementia

• People suffering from uncontrolled epilepsy

• Pregnant women

Resony Instructions for Use

1. Introduction

a. Indications of use

Resony is a digital therapeutic intended for the improvement of worry and anxiety and management of Generalised Anxiety Disorder (GAD) in adults aged 18 years and older, as an adjunct to their usual medical care.

For adults diagnosed with GAD, Resony should be used under the supervision of a healthcare professional.

For adults with worry, anxiety and stress, Resony may be used as a non-prescription self-management tool to improve mental health and wellbeing.

b. Benefits of Resony

Research shows that these techniques are effective in helping people reduce their worry, anxiety and stress. These techniques may reduce physical and psychological symptoms such as inability to relax, fatigue, trouble sleeping, muscle tension or muscle aches, trembling, feeling twitchy, nervousness or being easily startled, sweating, nausea, and diarrhoea.

c. Who should use Resony

Resony is suitable for you if:

• You are 18 years and older

• You are experiencing difficulties with worry and anxiety

• You have been diagnosed with Generalised Anxiety Disorder

• You are able to read, hear and understand English

• You have regular access to a mobile device

• You have access to the internet

d. Who should not use Resony

Resony may not be suitable for you if:

• You are suffering with severe Generalised Anxiety Disorder

• You are suffering with severe depression with and without risk of self harm

• You are suffering with uncontrolled symptoms of schizophrenia, bipolar disorder and severe obsessive-compulsive disorder, panic disorder, and dementia

• You are suffering from uncontrolled epilepsy

• You are Pregnant

2. Safety Information 

a. Safety information and warnings

• Resony is not a substitute for other medical or mental health treatment. The medical advice provided in Resony should not be solely or primarily relied upon to treat psychiatric conditions. Please don’t make any changes to your medications or treatment plan without consulting your doctor.

• Resony does not provide crisis support. If you are experiencing a medical emergency, including self-harm and/or suicidal thoughts, call NHS 111, call your GP, or go to your nearest A&E department.

• If you notice a worsening of your anxiety or depression symptoms while using Resony, please consult your doctor

• Using a mobile phone and/or tablet whilst driving or operating heavy machinery is a severe safety hazard due distraction and possible resulting accidents. Please do not use the Resony app whilst driving or operating heavy machines.

b. Side effects

• No serious adverse events have been reported in relation to use of Resony.

• The Resonance Breathing exercise requires a slowing down of breath and depending on the breathing process, this may lead to a sense of breathlessness, when forcing the pace of the breath. This may cause an initial aggravation of stress or anxiety symptoms. If this is the case, we recommend against forcing the breath. In this case, we recommend that users listen to the breath pacer initially and only join in with the breath pacing when and for as long they are feeling comfortable.

• Practicing Resonance Breathing and/or Progressive Muscle Relaxation may trigger sedation and can also occasionally lead to lightheadedness or involuntary hyperventilation. These symptoms are harmless and always temporarily end after ending the exercises.

3. Resony

a. General description

Resony is a digital therapeutic for the improvement of worry and anxiety and management of Generalised Anxiety Disorder (GAD).

GAD is a mental health disorder characterised by excessive worry and anxiety that is difficult to control and is accompanied by related symptoms, such as tension, restlessness, fatigue, irritability, and significant distress or interference in functioning.

Occasional anxiety is a normal part of life. Many people may worry about things such as health, money, or family problems. But people with GAD feel extremely worried or nervous more frequently about these and other things, even when there is little or no reason to worry about them. GAD usually involves a persistent feeling of anxiety or dread that interferes with how you live your life. It is not the same as occasionally worrying about things or experiencing anxiety due to stressful life events. People living with GAD experience frequent anxiety for months, if not years.

Resony consists of a digital structured therapeutic programme to improve worry, anxiety and help people reduce stress and build resilience. The programme consists of psychological and physiological techniques such as cognitive behavioural therapy (CBT) exercises, mindfulness exercises, progressive muscle relaxation exercises (PMR) and resonance frequency breathing exercises.  In scientific research CBT, PMR and resonance frequency breathing have shown to effectively reduce stress and anxiety and to improve mood. All those treatment modalities have shown to be effective and safe in the treatment of stress related conditions and anxiety and in the clinical context of Generalised Anxiety Disorder.

b. Recommended use

Welcome to the Resony generalised anxiety programme. This is a 6 week programme in which you will be expected to use the Resony app 3 times a day in the following way. In the morning, you will start with the Resonance Breathing exercise, which will prime your nervous system for a calm day. At lunchtime, you will do some gratitude journaling in order to remind yourself of all the positive things in your life. In the evening, when you are lying down in bed, you will do the progressive muscle relaxation which will relax your body and interrupt potential intrusive thoughts, so that you will be able to sleep well and recharge. 

The purpose of this programme is to create a routine that becomes integrated into your life, in order to minimise your average level of anxiety, prevent excessive stress response and manage intrusive thoughts or physical sensations when you have them. The exercises might be challenging at the start as you might not be able to stop thinking and focus. But stick with it, it will get easier the more you practice. This is why it is so important to maintain this daily routine, so you build the skills and prevent your anxiety from getting out of control in the first place. Most people like you found that the programme really made a difference for them after about 2 to 3 weeks, once they mastered all the exercises. If you ever forget an exercise, it’s ok, you don’t need to do it later. Just do the right exercise at the right time and commit to the practice. This is especially important if you are having a very busy time, because these tend to be the more stressful times! Each exercise only lasts for 5 or 10 minutes, so make sure to prioritise that for your own mental health and productivity. 

If and when you do experience peaks of anxiety, you do have access to two optional exercises called acute exercises which are explained in the next video. Remember to use them when you are experiencing high levels of anxiety. 

As you already know, there also are 4 psycho-education videos, which are just to help you understand what the app does and why it works, keep watching them weekly, and you can always go back to them. 

The last part of this programme, which is very important, are the questionnaires that you fill in periodically. These are extremely important because they enable us to ensure that you are safe, and to improve the content and quality of the programme to help you reduce your anxiety levels even more. If you don’t complete the questionnaires, we don’t know whether Resony is working for you, and we are here to help you, and to make sure that you are benefiting from the app!

4. User instructions

a. Signup and download the App

Download the Resony app from the Apple App Store or Google Play store from your mobile device. After installation, click on the “Sign up” button to create an account.

b. Questions/Assessments

You will be asked some questions about your emotional wellbeing and symptoms of stress and anxiety. Answer these questions to the best of your ability.

In some cases, we use the answers to your questions to tailor the experience of Resony to you. It is recommended that you complete these questions on a weekly basis.

c. Program and Techniques

The core component of the App is a structured program which lasts for 6 to 8 weeks. The program consists of individual techniques, which you are advised to practice daily as suggested by the program.

Resony introduces three main techniques:

• Resonance Breathing

This is an audio-guided breathing technique to  transform the negative impact of anxiety and stress into engagement thereby supporting health. The animation and breath pacer will help you learn the exercise and easily practice it. It is recommended to practise this exercise regularly in the morning for 5 to 15 minutes to reduce stress, anxiety, and low mood and to protect health and build resources for peak performance in challenging circumstances. 

• Progressive Muscle Relaxation

This is a well-established deep relaxation technique that has been used to reduce stress (strain and tension) and anxiety. It also increases recovery and regeneration of body and mind and to prepare for good quality sleep. Practicing this exercise every night before falling asleep also facilitates reduction of stress and anxiety during the day.

• Gratitude Journaling

This exercise helps reframe negative experience and creates an enduring positive emotional state that is a foundation for anxiety reduction.The technique is based on cognitive and behavioural science, and positive psychology. This is an interactive exercise within Resony.

5. Support

If you need technical assistance or in case of issues with the App, please send an email to support@resony.health and we will get back to you soon