In this trial, we are focusing on the diagnosis of bipolar disorder and depression.
We hope to improve the detection of these disorders by combining a digital questionnaire with a blood spot test for biological markers.
We are recruiting individuals who have been diagnosed with depression or bipolar disorder, as well as individuals with no diagnosis who have concerns with low mood.
Participants will contribute to the trial by completing a digital questionnaire and
an optional blood spot test and telephone interview, after which they will receive a detailed Results Report. There will also be a short follow-up questionnaire at 6 and 12 months.
Conducting this trial will allow us to improve the accuracy of the questionnaire and blood spot test, and to make the whole tool as user-friendly as possible.
This trial is being run by a team of researchers at the Cambridge Centre for Neuropsychiatric Research (CCNR) under the direction of Professor Sabine Bahn.
The CCNR is a lab based in the Department of Chemical Engineering and Biotechnology at the University of Cambridge, researching into treatments for psychiatric disorders.
The funding for this research comes from the Stanley Medical Research Insititute.
For this trial, we are supported by a University of Cambridge spin-out company called Psyomics Ltd.
Before registering for the Delta Trial, we need to check that you meet the eligibility requirements. This involves answering a few questions on your current situation and mood. If eligible, you will then be able to sign up to the Delta Trial.
Before you consent to participating in the Delta Trial, you will be asked to read the Participant Information. This contains a lot of information about the trial, including what you will have to do, how long it will take, and what you will get in return.
The consent form is at the bottom of the screen (after you’ve scrolled down), and includes 6 yes/no questions asking you about what you agree or don’t agree to. If you say yes to participating in the trial, you can then set up an account by entering your email address and a password.
The digital questionnaire includes 6 separate question sessions.
You will be guided through the questions on the Delta Trial app.
Each of the 6 sessions will take anything from 5 to 20 minutes to complete, but this will depend on your answers. Feel free to answer these questions at any point over a 2-week period.
The blood spot test is a simple process that should take around 15 minutes. It involves you providing a small dried blood spot sample by using a kit that will be delivered discreetly through your letterbox.
You will be given the option to opt in or out of receiving a blood spot test kit in the consent form.
Some of our participants will also be asked to take part in a telephone interview about mental health symptoms. This interview was designed by the World Health Organisaton, and involves a set of structured questions that tend to take around 45 minutes to 1.5 hours in total.
The telephone interview is another optional part of the Delta Trial, but it is interdependent with the blood spot test kit – i.e. you can either opt in for both or neither.
When you have completed all of these previous steps, you will receive your Results Report.
The reports have been designed to help you better understand your own challenges with mental health, and to point you towards a few of the best options for support if and when you need it.
This report will contain:
1. Your mental health screening results
2. Information about any mental health challenges that may be affecting you
3. Direct links to a variety of sources of mental health support
We will get back in touch with you 6 and 12 months after completing the rest of the trial to ask you to fill out a short set of follow-up questions.
These questions will ask about any changes in your mental health since the trial.
Your contribution to our research as a Delta Trial participant is crucial in helping us improve the understanding, diagnosis and management of bipolar disorder and depression. We hope that in the future this research will lead to improvements in patients’ lives.
In return for you giving us your time and personal information, we will provide you with:
Select the link below to download a PDF version of the Participant Information (also shown in the app on the consent page). This information sheet contains everything you need to know about the Delta Trial.
We have had to set a few inclusion/ exclusion criteria due to the specific requirements of the trial design and ethics committee.
You will not be able to participate if you:
In addition, you will not be able to complete the blood spot test part of the trial if you carry any blood-borne diseases (hepatitis, HIV etc). You will still be able to participate in the trial by completing the digital questionnaire, however, and will still receive a Results Report after this.
This trial is being run by the Cambridge Centre for Neuropsychiatric Research (CCNR). The CCNR is a research lab at the University of Cambridge that focuses on understanding more about the underlying mechanisms of and treatments for various mental health disorders.
For more information about the CCNR, visit our website by clicking on the link below.
The CCNR is funded by The University and The Stanley Medical Research Institute (SMRI), which is a US non-profit organisation/charity that supports the CCNR’s research.
For more information about the SMRI, visit their website below:
The online questionnaire has been developed through a collaboration with a small company called Psyomics Ltd., which also manufactures the blood spot test kits and is providing staffing support for the study. Psyomics Ltd. is funding these aspects of the Delta Trial.
For more information about Psyomics Ltd., visit their website below:
All results of the study are owned by the University of Cambridge
The Delta Trial app is a “web app”, rather than a “native app”. This means that you don’t have to download anything onto your device. A web app is effectively a website, and therefore can only be used when connected to the internet (as opposed to native apps which can be used offline). Don’t worry if you lose your connection mid-use, however – your progress on the app is saved automatically.
The Delta Trial app is supported by the following devices:
Once you have signed up and have login details, you will be able to continue use of the Delta Trial app using any of the above devices.
Please note that some of the text in the app may appear quite small on a mobile phone screen. If you find it hard to read small text, we recommend you use a desktop or laptop computer, or a tablet device to complete the Delta Trial.
The Delta Trail app has been designed to work on the following internet browsers:
On the login page, there is an option to select “I have forgotten my password”. This will result in an email being sent to you with instructions on how to reset your password. If you enter the wrong password 5 times in a row your account will be locked for 5 minutes. After this you will be able to attempt login again, or reset your password.
You can log out by clicking on the small symbol located at the top right-hand corner of your Delta Trial app home page (see the example below).
We recommend that you log out from your account every time you leave the app in order to protect your information.
Because the questionnaire adapts to the answers you have already provided, the number of questions will not be the same for every participant. As a result, we cannot tell you how many questions you will answer in total.
Everyone will answer 6 sessions of questions, however.
Each of the 6 sessions will take anything from 5 to 20 minutes to complete, but this will depend on your answers. You can choose to answer these questions at any point over a two-week period, but we recommend answering 1-2 question sessions per day over 3-6 days.
No. The questionnaire website saves your answers immediately. If you close the questionnaire or lose internet connection at any point, you will be able to start the session again exactly where you left it.
Your answers will be stored on our secure UK servers. Only a few ethically-approved individuals will have access to your personal information, including name and email address. The rest of the team will only be allowed to see your answers after your personal information has been replaced with a participant number (i.e. your profile is no longer identifiable).
Our previous research shows that amounts of certain proteins in our blood change when we are affected by bipolar disorder or depression.
We do not understand why yet, but we are hoping to find out. We are also hoping to use measurements of these proteins to help with diagnosis – in
other words, use them as biological markers, or “biomarkers” of bipolar disorder.
Your sample will help us to do this.
The blood spot test kit will contain all of the materials needed for you to provide us with a dried blood spot sample. The blood spot is collected from a small pinprick to your finger, which you will then mail with a pre-paid envelope back to our labs at the University of Cambridge.
The sample collection process is quick and easy to complete (around 15 minutes), and your kit comes with a clear set of instructions for you to follow.
You will be given the option to opt in or out of receiving a kit in the consent form.
If you opt out, please note that you will not be eligible to receive a clinical telephone interview.
If you opt in (consent) to receive a kit and meet the inclusion requirements, you may be selected to receive a kit. Due to the design of the trial, we cannot send kits to all consenting participants. We will email you after you have completed the question sessions to let you know the selection outcome, and to point you onto your next stage in the trial.
The kit should arrive within 1-3 days of receiving the email saying your kit has been dispatched. If you still haven’t received your kit 5 days after this email, please contact us at email@example.com and we will look into it.
Nothing – receiving, completing and sending the kit is completely free for you. The kit box contains a stamped envelope for you to return your sample in.
The kit will arrive in neutral packaging to maintain confidentiality.
You will be able to recognise it in the post from the University of Cambridge logo on the address label. There will be no other sender information. Your kit package will be in the shape of a rectangular letter, and will be delivered through your letterbox.
We have made an instructional video that shows you how to use the kit contents to provide and send back a sample. You will be able to view this in the app after your kit has been dispatched, and it is also available here.
This interview has been designed by the World Health Organisation (WHO) and is used all over the world by experts to diagnose mental health conditions. The interview’s official name is ‘the Composite International Diagnostic Interview’, or the CIDI. We are using the results from these interviews to check the accuracy of our combined digital questionnaire and blood spot test.
All of the interviewers are professionally trained and bound by confidentiality. In addition, you will remain anonymous to the interviewer – they will
only know your first name and number.
However, we understand that you may not feel comfortable sharing experiences of mental health difficulties with a stranger over the phone. For this reason, you are given the option to opt out of the clinical telephone interview in the consent form. Please note, that you can only consent to either both the blood spot test and clinical interview or neither – you will not be able to choose one but not the other.