A clinical trial by
University College London

Become a participant and win up to $130 USD!

You are being invited to take part in a research study for people with depression, the juli study that is being conducted by University College London (UCL).

Before you decide whether to take part, it is important to understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with others (e.g., family or friends) if you wish. Take your time to decide whether or not you wish to take part. If you are interested in taking part you can dowload the app and complete a brief questionnaire to ensure you are eligible here. You may then continue to the consent form. Thank you for reading this.

If you have any questions about the study please contact: trials@juli.co

Introduction

Each year, millions of people are diagnosed with depression. It can be overwhelming learning how to manage and unclear what can make symptoms better or worse. Many people seek additional support via digital applications. We built a digital app called juli to help people understand their condition and address issues in a way that might help them feel better. We aim to build upon the current research in smartphone delivered interventions, an approach that eliminates many of the barriers in help-seeking often observed, as well as providing an accessible, cost-effective alternative to clinician-based therapy. This method has the potential to provide access to effective interventions for those who may otherwise be overlooked by clinical services. The juli app is available from the Apple App Store in all countries. It has been used by many individuals without any reported adverse events.

However, we are still not certain how useful juli is compared to what people may do for themselves to help their depression. So we are carrying out an eight week, randomised controlled trial of juli to understand if juli is effective in reducing depression symptoms. The primary objective is to investigate whether the juli app is effective in improving depression symptoms in people with depression (compared to treatment as usual) at eight weeks. The secondary objective in both cases is to investigate effects on health related quality of life.
juli aims to support people with depression via a number of evidence based approaches including symptom tracking, medication reminders, journaling, data visualisation of sleep, activity, exercise, heart rate variability, and behavioural change technique recommendations about how to improve these parameters.

If you are interested in taking part in this 8-week test, please download the app here and read the instructions below. As a small compensation you may participate in a raffle after each biweekly stage. As compensation for your time, you will be entered into a cash prize draw every two weeks, after completing a questionnaire.

Instructions / What to expect

The test will run for 8 weeks. After downloading the app you will be asked a few questions in order to assess whether you are eligible to participate in the test. If you are you will also have to fill out a consent form.

After onboarding you will be assigned randomly to a test group that will give you access to more or less functionality of the juli app for the upcoming 8 weeks.

Regardless of which group you are in you will be asked about your wellbeing on a daily basis and every two weeks we will ask you to complete a more detailed questionnaire. Please make sure that you answer this questionnaire to be eligible to participate in a prize draw for $26/£20. During the 8-week study there will be 5 opportunities to win (totaling $130/£100).

After the end of the test you may continue to use juli free of charge as long as you want.

You can download juli in the app store.

Taking part

I cannot download the app!

The app is available in the app store. Just click on the button below to download it. Unfortunately juli is only available on iOS, so if you have a android handy you can not take part in the test.

I didn’t find the consent form.

The first questions assess whether you are eligible for the test. The severeness of your condition has to be within a certain range in order to be a test participant. If you happen not to be within this range, unfortunately you may not participate in the test and hence will not get the consent form. Needless to say that you may use juli independently from the test! If you are eligible you will be shown the consent form in the app after being asked whether you want to participate in the study.

Will I receive any payment?

Although there is no payment for taking part in the study, you will have an opportunity to win £20 (or local currency equivalent, i.e. $26) each time you complete a questionnaire set (baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks) .

What will taking part involve?

You should download the app, go through the baseline questionnaire and fill out the consent form. If you have any issues signing in to the app, we can help with that. During the sign-up process you will be asked questions about your background (age, gender), history of depression (how long since you were diagnosed? Do you see a doctor regularly?), current symptoms (a regularly used symptom questionnaire) and treatment (do you take regular medication?).
We will randomly allocate people (i.e., assign by chance) to receive juli or a dummy version of juli.

We’d then like you to use juli for the next eight weeks, including a depression questionnaire every two weeks
(four in total). We’d also ask that you complete a wellbeing questionnaire at four and eight weeks and a user satisfaction questionnaire at eight weeks.

These are all standardised questionnaires, commonly used for research (the Patient Health Questionniare-8, the 12-Item Short Form survey of health-related quality of life and the Mobile Health App Usability Questionnaire).

Taking part in the study will not alter the care you receive elsewhere. You should continue with your current treatment.

Are there any disadvantages in taking part?

This is a randomised controlled trial therefore you cannot choose which version of juli you receive. You should be aware that using the app may not improve your asthma. You should carefully consider this when deciding whether to take part. If at any time during the test you feel that your symptoms are getting worse you should contact your usual healthcare provider and the Principal Investigator (Joseph Hayes).

What are the possible benefits of taking part?

Some people find it rewarding to take part in medical research, and appreciate the additional monitoring. Using juli may improve your symptoms of depression, however, this cannot be guaranteed.

We also hope that by carrying out this study we will help future guidance about when someone is likely to benefit from juli and how we can improve it. There may not be direct benefits of taking part for you. However the study is designed to improve treatment and increase understanding of depression.

I don’t want to carry on with the study, what should I do?

You can stop using juli at any time, but we would still like you complete the follow-up questionnaires so that we can monitor your progress. If you don’t want to carry on with the study assessments, you can withdraw from the study at any time. The information already collected may still be used, unless you would like it withdrawn. You will be able to withdraw your data up to 4 weeks after the end of your participation in the trial.

In order to withdraw just go to the profile section of the app and select the test consent form. At the bottom of the form is the option to withdraw from the test.

What if there is a problem?

If you have further questions or if you have a concern about any aspect of this study, you can contact the Principal Investigator (Joseph Hayes) .

If you are unhappy with how you have been treated or if you have been injured whilst participating in this study please contact the Principal Investigator (Joseph Hayes). If you feel your complaint has not been handled in a satisfactory way (by the Principal Investigator), you should contact the Chair of the UCL Ethics Committee (ethics@ucl.ac.uk).

My Data and me

What data does the app collect?

The app collects some data automatically from your phone and smartwatch. This includes:

Sleep – time in bed and time asleep
Activity – steps and flights of stairs climbed
Heart rate variability – the variation in the time interval between heartbeats
Workouts – periods of exercise
Menstrual cycle - if tracked through Apple health

In some versions of juli you will also be asked to rate your mood on a daily basis, enter details in a journal and record your medication.

How is my data kept secure?

During the trial you will be randomly allocated to one of two versions of the app: the full version or the dummy version.

The full version of the app presents you with graphical displays of some data automatically generated from your phone and smartwatch. The types of data are: sleep – time in bed and time asleep, activity – steps and flights of stairs climbed, heart rate variability – the variation in the time interval between heartbeats, workouts – periods of exercise, and menstrual cycle. It also presents you with external data: weather, pollen count and air quality (provided via geolocation). It asks you to rate your mood and energy levels on a daily basis. It allows you to set a medication reminder, and add notes to a journal. It presents you with correlations between these different types of data and helps you to identify things that make your depression better or worse.

If you are allocated to the dummy version of the app, you will be asked to rate how you are feeling on a daily basis, but will not have access to the rest of the app. At the end of the eight week trial, if you wish to, you can access the full app.

Will my taking part in this study be kept confidential?

All information collected about you during the study will be kept strictly confidential. Only authorised individuals will have access to your data, this will include the study team and people organising the research.

You will be allocated a study number, which will be used as a code to identify you on all trial forms.

You will not be identifiable in any published report from this study. After the results of the study are available, the data will be anonymised (all personal information removed), so it will not be possible to identify you from the data.

All the information collected will be stored securely according to the European Union General Data Protection Regulation and the United Kingdom Data Protection Act 2018, and will be stored for at least 5 years.

Limits to confidentiality: Please note that assurances on confidentiality will be strictly adhered to unless evidence of wrongdoing or potential harm is uncovered. In such cases the University may be obliged to contact relevant statutory bodies/agencies. Confidentiality will be respected subject to legal constraints and professional guidelines.

Why have I been chosen to take part?

You answered our call for participants, are aged 18-65, are an English speaker, have an iPhone and are experiencing depression. We want to find out whether using juli will help people like you. We hope around 476 people with similar symptoms as yours will agree to take part.

Do I have to take part?

No, taking part in this study is voluntary. It is up to you to decide whether or not to take part. Whether or not you decide to take part will not affect the care you receive from elsewhere. If you would like more information to help you make a decision, please contact us (trials@juli.co). If you are interested in taking part you can download the app and complete a brief questionnaire to ensure you are eligibe. You may then fill out the consent form and complete a brief questionnaire to ensure you are eligible. Not everyone who completes the screening questionnaire will be suitable to take part in the study. You do not have to take part unless you feel completely happy with what you are being asked to do. You are free to withdraw at any time without giving a reason.

Data protection privacy notice

The controller and processor for this project will be juli Health. Data passed to UCL will be fully anonymised and stored encrypted.The categories of personal data used will be as follows:

Email address, geolocation

The lawful basis that would be used to process your personal data will be performance of a task in the public interest.

The categories of special category data used will be as follows:

Health data (baseline questions: age, gender, was depression diagnosed by a physician? How long have you had depression? Do you see a physician regularly about your depression? Do you take regular medication? Patient Health Questionnaire-8 score at 0, 2, 4, 6, 8 weeks, the 12-Item Short Form survey of health-related quality of life at 0, 4 and 8 weeks, and the Mobile Health App Usability Questionnaire at 8 weeks)

The lawful basis used to process special category personal data will be for scientific and historical research or statistical purposes.Your personal data will be processed so long as it is required for the research project. Data will be held for 5 years after completion of the trial. We will anonymise the personal data you provide, and will endeavour to minimise the processing of personal data wherever possible.

If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact the juli Health Data Protection Officer (Joris Straatman) in the first instance at js@juli.co.

Contact for further information: If you have any questions about the study please contact: trials@juli.co or the Principal Researcher joseph.hayes@ucl.ac.uk

The Study

What does the app do?

During the trial you will be randomly allocated to one of two versions of the app: the full version or the dummy version.

What is the purpose of the study?

Each year, millions of people are diagnosed with depression. It can be overwhelming learning how to manage and unclear what can make symptoms better or worse.

We built a digital application called juli to help people understand their condition and address issues in a way that might help them feel better. Juli is designed to track important things that we know are affected by and impact on depression. These include sleep, movement, screen time, activity, heart rate variability and daily changes in mood.

However, we are still not certain how useful juli is compared to what people may do for themselves to help their depression.

In order to find out who might fully benefit from juli, we need to compare different versions of juli. The study will include people with depression where they feel they might benefit from additional support in the form of a digital application.

What happens, when the study stops?

After the study is complete, we hope that your depression will have improved. If you want to, we will invite you to continue to use the full version of juli. If not, you will stop using juli and continue your regular treatment. If you choose to continue to use juli we’d like to use your anonymous data to examine longer term outcomes and for this would collect data from the depression questionnaire at 12 weeks and 24 weeks. We will retain your data for 5 years from the completion of the trial. If you agree, we would like to make your fully anonymised data available to authenticated researchers from UCL for further studies.

We may arrange new studies on depression in the future which you may be able to help with. Therefore, you will be asked whether you are willing for us to contact you by email to inform you of new projects on depression.

What will happen to the results of the research study?

When the study is completed, the results will be published in a healthcare journal so healthcare professionals can see the results. If published, your identity and personal details will be kept confidential. No named information about you will be published in any reports about the study.

Who is funding and organising the research?

The research is being organised by University College London in collaboration with juli Health. juli Health is funding the research.

Who has reviewed the study?

The study has been reviewed and given a favourable opinion by the UCL Research Ethics Committee.

UCL Research Ethics Committee Approval ID Number: 19413/001

Principal Researcher: Dr Joseph Hayes joseph.hayes@ucl.ac.uk

This is a UCL research study, funded by juli Health, sponsored by UCL. The Principal Researcher is an employee of UCL and a Co-founder of juli Health.

A clinical trial by University College London