Anxiety
Acorn ll
Calling for participants until
01 Nov 2027
Participant type
Adults
Rewards
£20 Retail Voucher per completed follow up- totalling £100
Overview
We are inviting pregnant women and birthing people, aged 18 or over and between 12 and 20 weeks pregnant, to take part in the Acorn II study.
In a previous small study, we developed and tested a support programme called CALM with pregnant people experiencing anxiety, the CALM programme helped to reduce their symptoms of anxiety.
We now want to run a larger trial to see if CALM can improve anxiety during pregnancy and whether these benefits last up to a year after the baby is born.
You can also visit our study website for more detailed information https://acornii.co.uk/
If you are interested in taking part, or would like more information, please call 01392 674117 or email dpt.researchadmin@nhs.net.
Summary
We are testing whether our CALM support programme works better than the usual care for reducing anxiety during pregnancy. A smaller study has already shown that CALM can help.
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There is a 50% chance you will receive usual care instead of CALM. Usual care means you will see your midwife as normal, or be referred to a primary care mental health service if needed.
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If you join the trial, we will ask you to fill in questionnaires on six more occasions over 18 months: before the support starts, at 22 weeks pregnant, 32 weeks pregnant, and then 3, 6, and 12 months after your baby is born.
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You are 18 or older and able to agree to take part in the study yourself.
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You are between 12 and 20 weeks pregnant.
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You are experiencing anxiety which will be assessed by the research team using a standard questionnaire.
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Feeling very low or having thoughts of harming yourself - We'll ask one short question from the Edinburgh Postnatal Depression Scale to check this. If you say yes , one of our trained clinicians will speak with you to understand how you're feeling and make sure you have the right support and if the study is right for you.
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Alcohol, smoking, or other substances - We'll ask a few quick questions about smoking, alcohol, and drug use, just so we can understand your overall wellbeing and if the study is right for you.
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Past mental health diagnoses - We'll ask if you've ever been told you have psychosis or bipolar I disorder. Unfortunately, if you have had either of these diagnoses, this study wouldn't be suitable for you, but we can help signpost you to other sources of support.
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Difficult or traumatic experiences related to birth - We'll ask if you've ever been through something where your life, or a loved one's life, was in danger, or if you found your childbirth experience traumatic. If you answer yes , we'll invite you to complete a short questionnaire to see whether you might benefit from extra support for PTSD (post-traumatic stress disorder).
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Current support for anxiety - We'll check whether you're already receiving treatment for anxiety at the start of the study, this may exclude you from the study.
Meet the researcher
Antoinette DaveyAntoinette Davey is the Clinical Trial Manager at Devon Partnership NHS Trust for the ACORN II trial (antenatal anxiety). She has worked on multiple NIHR-funded projects at the University of Exeter, including studies on depression post-cardiac event (CADENCE), community perinatal mental health (ESMI-II) and primary care experience measures (GPPS). Antoinette holds a PhD on cyclical variation in patient-reported outcomes and has published over 30 peer-reviewed articles. She regularly presents her research nationally and internationally and collaborates with the UK PROMs network, representing them in the global PROTEUS consortium for PROMs implementation in clinical care.
Collaborators
