Could you help to test the accuracy of a questionnaire in identifying women with psychological distress following a miscarriage?
We are sorry for your loss. We know that having a miscarriage can be a traumatic and distressing event. It is common to feel like this, for most women this starts to improve after a few weeks. However, for some women, pregnancy loss may be part of what causes a mental health problem - or makes one worse.
At the moment there is no validated way of identifying those women that need more support or help from a mental health specialist.
We need your help to test the accuracy of the Core-10 questionnaire at identifying those women that may be at risk of developing more prolonged psychological distress.
We welcome women of any ethnicity or background to take part. We will try our best to offer translation in your preferred language. To find out more you can check our website https://www.birmingham.ac.uk/research/maternal-health/our-research and/or contact us on 01932 723534.
FAQs
Do I have to take part?
Taking part in the study involves completing an online assessment called CORE-10 and taking part in up to 2 interviews.
Participation in our study is entirely voluntary. If you decide to take part, we will check you are eligible and you will be asked to sign a consent form. If you do not wish to take part, you will not have to give a reason and your decision will not affect the care you will receive. Similarly, if you do decide to take part, you will be able to withdraw from the study at any time and without giving a reason, and without any effect on the medical care that you receive.
Are there any specific criteria to be able to take part?
Yes, in order to be able to take part in the study you must meet the following criteria:
- Female
Primiparous (Women in their first pregnancy) or multiparous (women who have given birth more than once) - Ability to provide written informed consent to take part in the study
- Age ≥ 18 years old
- Diagnosis of miscarriage ≤16 weeks (Singleton or multiple pregnancy) acquired from hospital records
- Recurrent or sporadic miscarriage
If I meet the requirements, are there any specific criteria which would mean I cannot take part?
The following list is our study exclusion criteria:
- Miscarriage > 16+1 weeks
- Other types of early pregnancy loss (e.g. gestational trophoblastic disease or ectopic pregnancy) acquired from hospital records
- Termination of pregnancy
- Prior enrolment in this study
What is the CORE-10 assessment measure?
The CORE-10 is an easy-to-use assessment measure that consists of 10 questions and takes on average 2 minutes to complete. It is an easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress.
The measure is a shortened version of the 34 item CORE-OM, both of which ask respondents to self-report symptoms over the past week.
When should I take the assessment?
Prior research tells us that three months after miscarriage is the timepoint where we are more likely to identify those women that need further support or referral to mental health specialists.
How can I complete the assessment?
The assessment can be completed by you online. You will be asked to complete the questions based on how you’ve felt over the last week. We will email and/ or text you a link to complete the survey. It should take 2-3 minutes to complete.
Will my GP be notified?
Your GP will be notified that you are taking part in this study. If your result shows that you are experiencing distress we will contact you and notify your GP for further support and management. The next steps will vary according to your individual situation but you will be supported. If there are concerns that you need urgent help a health care professional will contact you.
What happens after the assessment?
Everyone who completes the assessment will have a interview with a SCID (structured clinical interview for DSM-5 disorders) trained individual. The SCID is a diagnostic clinical interview for mental health disorders listed in the diagnostic and statistical manual (DSM-5). The interview takes on average 1-1.5 hours.
Some women may be contacted after the SCID and asked to take part in an interview to share their experience of completing the CORE-10 questionnaire.
What happens next?
We will provide a patient information sheet for you to read. If you would like to take part, you will be asked to sign a consent form and provide your email address and contact number. We will send you a link for the psychological assessment to be completed at three months and a reminder closer to the time.
What are the benefits of taking part in this trial?
At the moment there is not enough evidence to say whether the Core-10 is the best way of identifying women who have prolonged psychological distress following miscarriage.
We do not know whether you will benefit personally from taking part in this study, but the knowledge gained thanks to your help will inform future practice and potentially lead to improved detection of mental health problems for women after miscarriage in the future.
What are the risks of taking part?
Completing the assessment should not add further distress. There are no specific questions related to your miscarriage. If this does cause any distress we are here to support you. You can contact the study team and the support organisations on the last page. If the CORE-10 identifies that you are experiencing mental health consequences of miscarriage, we would write to your GP and ask them to provide you with further support. If we are concerned that you have severe symptoms we would work with your local EPAU and GP to get you the right help quickly.
Further information about taking part in the study can be found in the patient information sheet.
