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. 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 the app in the app store.

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

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. If you have an android, you cannot 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, you will be unable to participate in the test and will not receive the consent form. Needless to say, you may use juli independently from the test! If you are eligible, you will be shown the consent form in the app after agreeing 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 an 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 Depression Control Test, 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 depression. 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.

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 
Oxygen Saturation – if you have a smartwatch to detect that.
Menstrual cycle - if tracked through Apple health

You will also be asked to rate your depression situation on a daily  basis, you may enter details in a journal and record your medication. 

How is my data kept secure?

Your data will be kept separately from details that could identify you (i.,e your email address). The juli app stores data in the same way physicians store your medical records and is Health Insurance Portability and Accountability Act (United States), General Data Protection Regulation (European Union) and Data Protection Act 2018 (United Kingdom) compliant.

Researchers analysing the data will not be able to identify you and will only be provided with the questionnaires for analysis, not the other data you may have entered into juli.

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. If your data is to be used for another study in the future full ethical approval will be obtained.

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 suffering from depression. We want to find out whether using juli will help people like you. We hope around 180 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 eligible. You may then fill out the consent form. 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.

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? Depression Control Test score at 0, 2, 4, 6, 8 weeks, the 12-Item Short Form survey of health-related quality of life at 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 anonymize the personal data you provide, and will endeavor to minimize 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.
The full version of the app present 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 depression situation and mood 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. 

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: sleep, activity, exercise, oxygen saturation, heart rate variability, external data including weather, pollen count and air quality (via geolocation), and behavioral change technique recommendations about how to improve these parameters. 

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 anonymized 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.

References:

1. “Depression.” World Health Organization, World Health Organization, https://www.who.int/news-room/fact-sheets/detail/depression.