Instructions For Use

Rejoyn for Depressive Disorder Episodes
Digital Therapeutic Software

These Instructions For Use are intended to ensure that Rejoyn is used correctly. Please read this information carefully and follow the instructions below. 

Intended Use

Rejoyn is a digital therapeutic intended for the treatment of depressive disorder episodes in adults. It is intended to be used alongside usual care provided by a Healthcare Professional. 

Intended Patient Population

Rejoyn is a smartphone app to be used by adults 18 years and older with depressive disorder episodes, commonly referred to as depression. It is intended to reduce depressive symptoms. Rejoyn should be used by individuals that are under the care of a Healthcare Professional, including whilst waiting for access to additional therapy or other care services.

How It Works

Rejoyn provides treatment composed of three parts: Therapeutic Lessons, Brain Exercises, and Personalised Reminders and Messages.

Frequency of Use

Rejoyn comprises of an active treatment period involving 6-weeks of alternating Therapeutic Lessons and Brain Exercises followed by a 4-week extension period during which you will have open access to the Therapeutic Lessons (10-weeks total). After the 10‑week period has ended, you will no longer be able to access Rejoyn.

Table 1: Rejoyn Features, Duration, and Frequency

*In a clinical study of Rejoyn, the majority of Brain Exercises were completed in this time frame. Duration will vary by individual user.

**Once the 6-week treatment period is over, Therapeutic Lessons are available to be revisited for an additional 4 weeks.

Important Safety Information: 

To access Rejoyn you will require an access code. This will enable your participation in the treatment programme using the smartphone application (app).

Rejoyn is not a replacement or substitute for your current medical or mental health care treatments. You should continue with your treatment as directed by your Healthcare Professional. Rejoyn is intended to be used alongside usual care as a treatment for depressive disorder episodes. Talk to your Healthcare Professional or dial 111 for additional information about treatments that may be right for you.

Rejoyn cannot send alerts or warnings to your Healthcare Professional. If you feel that your depressive symptoms are worsening or if you have feelings or thoughts of harming yourself or others, please contact your Healthcare Professional, dial 999 or go to the nearest Accident and Emergency Department immediately.

Operating Information

Rejoyn currently only supports mobile phone numbers local to the United Kingdom capable of receiving SMS messages. If your mobile phone number does not meet these criteria, please contact the support centre at +44 (0) 203 375 8575.

Rejoyn is intended for people who have access to a smartphone and are familiar with using a smartphone app.

An internet connection is required to download Rejoyn on your smartphone. Refer to the Apple App Store or Google Play Store on your smartphone to ensure compatibility of your specific smartphone and Operating System (OS). Rejoyn supports the two most recent iOS and Android OS versions.

Ensure your smartphone is running an OS version matching those required. If not, update your smartphone software version before downloading and using Rejoyn.

We recommend that you keep 100 MB of available storage on your device to use Rejoyn.

Rejoyn is not currently compatible for use with computers or tablets.

Please log into Rejoyn on your smartphone. This will make sure you do not miss any important reminders and will allow Rejoyn to remember where you are in your treatment.

Security

You are required to enter a username and password prior to using Rejoyn. Please do not share your username or password with others.

Required updates will be installed on your smartphone automatically, if automatic updates are enabled. Otherwise, you will need to visit the app store to manually install the update on your smartphone before you can proceed with your treatment.

Getting Started

• Rejoyn is intended for people with depressive disorder episodes who are comfortable with written and spoken English.
• Your Healthcare Professional must recommend Rejoyn and provide you with instructions on how to obtain an access code in order to use Rejoyn.
• An internet connection is required to download Rejoyn on your smartphone. Rejoyn is available for download from the Apple App Store and Google Play Store. The app can be found by searching for Rejoyn.
• When you open the Rejoyn app for the first time, you will need to enter the access code into the app.
• Next, you need to set a password that is at least 8 characters in length, and includes at least one uppercase letter, one lowercase letter, one number, and one special character (! # & %).
• You will need to verify your email address and mobile phone number.
• Once your email address and mobile phone number are verified, you can begin your treatment with Rejoyn. This includes completing brief Therapeutic Lessons and Brain Exercises. You will also start receiving reminders and personalised messages.
• During the 10 weeks period, you should continue with your current medical or mental health care treatment. Please discuss with your Healthcare Professional to review your treatment progress.

Terms of Use and Privacy Notice

During account creation, you will be asked to agree to the “Terms of Use” and “Privacy Notice”. The “Terms of Use” and “Privacy Notice” are accessible by clicking on “Important Information” on the app landing page.

User Introduction

After you complete your registration, you will be shown a set of screens that will guide you through your assigned activities and how to use the app. Tap the “NEXT” button at the bottom of each screen to navigate to the next screen. You can also tap the back arrow at the top to navigate to the previous screen.

There are six tasks per week, alternating between Therapeutic Lessons and Brain Exercises.

If you miss a day for any reason, do not worry. You can catch up by doing two tasks the next day to stay on your weekly schedule. You cannot do more than two tasks per day. At the end of each week, any remaining Therapeutic Lessons are unlocked so you can view them later, but the previous week’s Brain Exercises will not be available.

An example of the recommended treatment schedule is shown in Table 2 and an alternative schedule is shown in Table 3 below.

Table 2: Recommended Treatment Schedule of Therapeutic Lessons and Brain Exercises

Table 3 shows an example of an alternate treatment schedule where you start treatment in the middle of the week and ‘double up’ on tasks some days.

Table 3: Alternate Treatment Schedule of Therapeutic Lessons and Brain Exercises (Example)

Set a Reminder

You can choose to set a daily notification, which will remind you to do your daily task. If it is the first time you use Rejoyn, you will be prompted to set up this notification. You can click on “Skip This” to continue without setting up these notifications.

You can add your reminder to your smartphone’s calendar to help you stay on track with your programme. A prompt will display during the initial app set-up. You can click on “Add to Calendar” and follow the screen prompts. You can click “Skip This” to continue without setting up your calendar.

Home Screen

Each time you re-open the app, you will be taken to the Home screen.

On the Home screen, you can:

• Monitor your weekly progress goal at the top of the screen in terms of percent completion.
• Start an available Therapeutic Lesson by tapping on “Start” under “Lesson”.
• Start an available Brain Exercise by tapping on “Start” under “Brain Exercise”.

Patient Profile

You can access your profile by tapping on the “Profile” icon at the top of the Home screen.

Support

Tapping “Support” under “Profile” will give you access to the number you can call for technical support or to report any side effects or quality complaints.

Edit Profile

Tapping “Edit Profile” under “Profile” will allow you to change the following information:

• Name
• Password
• Phone number

Reminders

Tapping “Reminder” under “Profile” will allow you to manage your daily notifications and make changes if desired.

Important Information

Tapping “Important information” under “Profile” will give you access to the following information:

• Manufacturer
• App Version
• Intended Purpose
• Instructions for Use
• Terms of Use
• Privacy Notice
• Open Source Licenses
• Patent

Log Out

You can log out of the app by tapping on “Log out” at the bottom of the “Profile” page.

Reset Password

Your Password can be reset by tapping on “Forgot Password” on the login page or by editing “Profile” on your “Profile” page.

Privacy Choices

Tapping “Privacy choices” under “Profile” will allow you to manage your privacy options and make changes if desired.

• Tapping “Stop processing health data” will allow you to stop Rejoyn from processing your health data. Doing so will end your treatment and your access to Rejoyn. You should not stop your treatment, even if you feel better or for any other reasons without first discussing it with your healthcare professional.
• Tapping “Help us improve the application” will allow you to opt in or out of sharing data about how you use the application
• Tapping “Exercise other rights” allows you to exercise other rights including:
  • Right to information
  • Right of access
  • Rectification
  • Erasure
  • Restriction
  • Data portability
  • Objection to direct marketing
  • Right not to be subjected to automated decision making

My Plan

Your plan progress or upcoming Therapeutic Lessons and Brain Exercises for the week can be accessed by tapping on “My Plan”.

Tasks

Each week the Rejoyn treatment includes six tasks: three Therapeutic Lessons and three Brain Exercises.

The Home screen will display your daily tasks. You will need to complete the Therapeutic Lesson before you can unlock the Brain Exercise.

Therepaeutic Lesson

To begin your assigned Therapeutic Lesson, go to the Home screen in the app and tap “Start” which can be found in the Therapeutic Lessons box. Follow the instructions in the app to complete the Therapeutic Lesson.

When you complete the Therapeutic Lesson, tap “Done” and you will return to the Home screen to start your next task.

You can go back to finish Therapeutic Lessons any time from the “Learn” tab on the menu bar at the bottom of your screen.

Learn Library

There are a total of 18 Therapeutic Lessons. The Therapeutic Lessons are stored in the learn library and can be accessed by tapping “Learn”.

Toolkit

After the Therapeutic Lessons are completed, they will be added to the “Toolkit”. You can revisit and practice completed Therapeutic Lessons by tapping on “Toolkit”.

Brain Exercise

The Brain Exercises are designed to activate two parts of your brain that are responsible for emotion recognition and working memory. Activating these two parts of the brain at the same time is believed to help strengthen the connection between them. This may help the brain better process emotions and improve symptoms of depression.

The app will give you directions on how to complete the Brain Exercises. This may feel difficult at times, but that is normal. You will have as much time as needed to complete the Brain Exercise once you begin; however, if you start a Brain Exercise and are then interrupted for 15 minutes or more, the app will restart your Brain Exercise session for the day. It’s not about speed or accuracy. The point is to keep your brain challenged and engaged.

There are a total of 18 Brain Exercises. To begin your assigned Brain Exercise, go to the “Home” screen in the app and tap “Start” which can be found in the Brain Exercise box.

When you complete the Brain Exercise, tap “Done” and you will return to the “Home” screen.

Messages/Reminders

Rejoyn includes reminders to help keep you on schedule such as SMS text messages that reinforce the skills taught in the Lessons and are meant to encourage completion of the programme. Personalised SMS text messages also reinforce concepts and skills acquired during the lessons.

Continued Access

The 6-week treatment course is followed by a 4-week lesson review period where you will have continued access to the Therapeutic Lessons only. Brain Exercises will no longer be available during this 4-week period. After the 10-week time period (6-week treatment period plus 4-week lesson review period) has ended, you will no longer be able to access Rejoyn.

Clinical Benefits

Rejoyn was evaluated for its safety profile and effectiveness in 386 patients with depressive disorder episodes who were experiencing ongoing symptoms of depression while on their current antidepressant medication. In the clinical trial, patients received either Rejoyn or a Control App in addition to their antidepressant for 6 weeks. At the end of 6 weeks, the Rejoyn group showed a clinical benefit over the control group in reducing depressive symptoms when added to an antidepressant medication.

In two other studies with 75 patients experiencing a depressive disorder episode who were not on any antidepressant treatment, Brain Exercises, the main component of Rejoyn, were compared with a control group. These studies showed that Brain Exercises were more effective than control exercises in reducing depressive symptoms.

Summary of Safety

During the clinical trial, there were no side effects related to the use of Rejoyn.

Manufacturer

Otsuka Pharmaceutical Europe Ltd., 2 Windsor Dials, Arthur Road, Windsor, Berkshire, SL4 1RS, United Kingdom

To get Rejoyn support or report Rejoyn side effects or quality complaints, contact +44 (0) 203 375 8575

OR

To report Rejoyn side effects or quality complaints, contact +44 (0) 808 168 6726 or OPUKSafety@otsuka.co.uk

Available: Monday–Friday (excluding National Holidays)

Hours of Operation: 9 AM to 5 PM

Website: www.rejoyn.co.uk

Emergency

Dial 999 or go to the nearest Accident and Emergency Department if you are experiencing a medical emergency or you are in immediate danger of suicide.

If you have any questions about your depression, please contact your Healthcare Professional, or dial 111.

SOFTWARE VERSION

Please refer to the “Important Information” section in the Patient Profile section of Rejoyn for details of the current software version.

Date of issue of the instructions for use: 18-MAR-2025