Q. What will the online questionnaire ask me about?
The online questionnaire consists of 6 question sessions. These question sessions will ask you about your past and present mood, demographic details, lifestyle, personality, psychiatric history, general medical conditions, and other factors. The questionnaire assesses for symptoms of major depression, bipolar disorder, and other psychiatric conditions.
Q. Why was I excluded after filling the consent form?
There are several potential reasons why you may have been excluded:
- Your profile may not fully meet the eligibility criteria specified for inclusion in this study.
- The depressive symptoms you reported might not have reached the required threshold for participation.
- If you disclosed experiencing suicidal thoughts, this would lead to your exclusion for safety reasons. We would instead advise you to contact your GP or the Samaritans (http://www.samaritans.org/how-we-can-help-you/contact-us) by dialling 116 123. If you feel you are unable to keep yourself safe, call the NHS mental health line by dialling 111. If you urgently need help or support, call 999 or go to A&E. If you are unable to call or unable to get there by yourself, please ask someone to call on your behalf or take you.
- You may not have agreed to all the necessary conditions listed in the consent form.
If you believe you were excluded mistakenly, please revisit the main website and try to sign up again.
Q. Can I participate if my diagnosis of major depressive disorder is older than five years?
No, the study requires that the diagnosis of major depressive disorder has been made within the last five years. This is necessary to ensure the accuracy of the results, as the algorithm we use in the study has not been tested in patients whose diagnoses are older than five years.
Q. Will I get paid for my participation?
No, there is no reimbursement for participating. However, you will receive a personalized report based on your questionnaire answers, indicating whether you are likely to have bipolar disorder.
Q. I am unable to resume the questionnaire where I left off. How do I pick up from where I left off?
You can return to your partially completed questionnaire if you use the same device and web browser, your IP address hasn't changed, and your browser cookies and cache haven't been cleared. The questionnaire remains open for 2 weeks from when it was started.
If these conditions aren't met, you'll need to start the questionnaire again, as unfortunately there's no other way to resume from where you left off.
Q. What is the dried blood spot collection kit?
The kit will provide you with all the materials you need to collect a dried blood spot sample at home. If you are selected to donate a blood spot sample, the kit will be mailed to your address. The kit takes approximately 15 minutes in the morning to complete. You will also be sent a prepaid envelope to return the kit to us for analysis once you have completed it. Please note that not all participants will receive a blood collection kit. After processing your answers to the online questionnaire, the study team will confirm by email if you are selected to receive a kit.
Q. How will I know if I have been selected to receive a blood spot collection kit?
If you have been selected to donate a blood sample, we will get in touch with you by email so that you can tell us where to send your blood spot collection kit. In that case, it may take anywhere from several days to several weeks after completing the questionnaire before you hear from us.
Q. Can I return a non-fasting blood sample?
No, we will not be able to process non-fasting blood samples. Please collect your blood spot only after fasting for at least 6 hours (no eating or drinking anything other than water). A great time to do this is just before breakfast.
Q. Can I be part of this study if I have Factor VIII deficiency?
Yes, you can participate if you have Factor VIII deficiency (or haemophilia A). However, please consult your healthcare provider if you're invited to donate a blood spot sample, as this could help prevent any potential complications during blood collection.
Q. I accidentally spotted two drops of blood on one of the spots. Is my sample still valid, or do I need to redo it?
If at least one of the five spots on the collection card has a valid blood sample, your sample is still valid. Please return it to us for analysis and cross out any spots that shouldn’t be used.
If none of the spots are valid, please contact us for a replacement blood collection kit.
Q. Will my DNA be analysed from the blood sample?
No, we will not analyse your DNA.
Q. How will you know which sample came from which participant? The blood spot collection kit I received does not ask about my participant ID.
Each dried blood spot collection card is labelled with a unique barcode assigned to only one participant. We will match samples to participants based on these barcodes.
Q. When returning the blood spot sample, what should the return envelope contain?
The return envelope should contain only the silver bag, inside which there should be your dried blood spot collection card and desiccant gel bag. Please make sure the silver bag is zipped. Do not return any other items.
Q. My blood spot collection kit hasn't arrived/I did not manage to collect a blood sample using the kit provided. Can I request another blood spot collection kit?
Yes, you can request a replacement blood spot collection kit. Please contact us at ccnr@ceb.cam.ac.uk with your participant ID, and we will arrange for a new kit to be sent to you.
Q. I was not invited to send a blood spot sample. Does this mean I am unlikely to have bipolar disorder?
No, not being invited to send a blood spot sample does not indicate in any way your possible outcome. Invitations are based on specific responses from the online questionnaire and only a small proportion of participants are invited to send a blood spot. Regardless of whether you provided a blood sample, all participant reports are based on the online questionnaire results only. Blood testing results are not included, even for those participants who donated a blood sample.
Q. What will my report be based on?
The report will be based on your answers from the online questionnaire and our machine learning algorithm that can distinguish bipolar disorder from major depressive disorder in people with current depressive symptoms. The algorithm was developed in our previous study, and was 84% accurate in detecting bipolar disorder when compared to a diagnostic interview developed by the World Health Organisation, called the Composite International Diagnostic Interview. You can find more details about the algorithm here: https://www.nature.com/articles/s41398-020-01181-x.
Q. Will the blood marker results be included in the report?
No, blood biomarker results will not be considered in the report, even if you have donated a blood sample. This is because the blood test is still under development.
Q. Can your algorithm distinguish subtypes of bipolar disorder, such as bipolar I or II?
No, the algorithm will only indicate how likely you are to have bipolar disorder on a scale from 0 to 100%, without specifying its subtypes. It will also state which of your answers contributed most to this prediction. It is important to understand that the result from the algorithm is not a diagnosis. An accurate diagnosis can only be made by a medical professional in-person.
Q. When will I receive my participant report?
All study participants will receive their results reports at the same time, once the study recruitment phase has completed. We currently estimate this to be around November 2024.
Q. In my participant report, what are the "Other" items contributing to my outcome, listed after the top 10 predictive items?
The "Other" category includes 77 additional items from the questionnaire that contributed to your outcome. Each of these items had a smaller individual impact compared to the top 10 items, so they’ve been grouped together as "Other" for simplicity.
Q. Is the order of predictive items in the report and scoring of answers the same for all participants?
No, the order and scoring are unique to each participant and are context-specific. They depend not only on your answer to given question, but also on your answers to other questions.
Q. The report states that my probability of having bipolar disorder is close to the 50% cutoff. How certain can I be about my result?
A result around the 50% cutoff may feel uncertain, but any result above 50% indicates a greater likelihood of having bipolar disorder than not. This cutoff was chosen to balance accurately identifying people with bipolar disorder while minimising misclassification of those with major depressive disorder.
Q. Can the indication in my report be inaccurate?
Yes. Based on our previous study, the algorithm used to generate your report has an accuracy of 83% when compared to the World Health Organization's World Mental Health Composite International Diagnostic Interview (CIDI). This means it is inaccurate for approximately 17% of participants.
Q. The report states that my answer to the question about elevated/agitated mood—"I think I might have had a period of feeling like this in the past"—lowers the probability of having bipolar disorder. This seems counterintuitive. How is this possible?
This pattern emerged in our previous study, where we developed the algorithm using data from people with a validated diagnosis of either bipolar disorder or major depressive disorder. People who responded "I think I might have had a period of feeling like this in the past" were in fact more likely to have major depressive disorder than bipolar disorder. In general, only responses: "I have definitely had a period of feeling like this in the past" or "I am currently feeling quite similar to this" were associated with a higher probability of having of bipolar disorder.
Q. My report mentions bipolar I and bipolar II disorder. What is the difference between them?
Bipolar I disorder is characterised by extreme mood swings between high (manic) and—for most patients—low (depressive) phases. Bipolar II disorder is similar, but the high phases (called "hypomanic") are less intense than in bipolar I disorder. You can find more information about the subtypes of bipolar disorder on the Mind charity website at this link.
Q. Why are the blood testing results not included in the report? Can you share my blood test results with me?
Your blood test results are not included in the report because the testing is still under development and is conducted solely for research purposes. As explained during the study sign-up process, we cannot share individual blood test results with participants. These results are part of our effort to develop diagnostic tools and are not intended for individual health feedback. The findings from this research will be published anonymously in scientific publications, which you can follow on our publications website.
Q. How can I contact you if I have more questions?
You can contact us by email at ccnr@ceb.cam.ac.uk.