For Participants

Why are we doing this study?

• Up to 25% of women struggle with serious anxiety symptoms during pregnancy.
• These anxieties can be about the health of the baby, childbirth, and changes to the family.
• Many women will not improve without treatment, with symptoms continuing postnatally and for some, leading to depression.
• There is a lack of high-quality research about the best way to help mothers.
• In the NHS most mothers with antenatal anxiety (65%) are seen in primary mental health care (IAPT), but IAPT lacks treatments that specifically address antenatal anxiety.

Why have I been invited?

• We are approaching all pregnant women/birthing persons aged 18 and above at their first trimester scanning appointment to be screened for anxiety.
• If you are eligible, you will be invited to take part in the trial.

What do we want to find out?

• In a previous feasibility study we developed and tested an intervention called CALM with a smaller number of pregnant individuals with anxiety.
• CALM reduced their anxiety.
• We now want to do a bigger trial to see whether CALM improves anxiety in pregnant individuals during pregnancy and has long term effects up to a year after the baby is born.

What is the CALM intervention?

• 5-session group-based therapy delivered to pregnant individuals and their partners/close supporters alongside Treatment as Usual over a 5-week period.
• CALM uses evidence-based cognitive-behavioural and mindfulness strategies to address worry and pregnancy-specific uncertainties.
• It was co-produced with individuals who had experienced anxiety during their pregnancy.
• The intervention is delivered by a psychological worker and a maternity worker (e.g. midwife).
• Sessions can be done remotely or in person.
• There will be around 8 pregnant individuals in each group and their partners/close supporters (maximum of 16 in a group).

What is the Treatment as Usual (TAU)?

• TAU is either:
  • Support from a specialist mental health midwife, or;
  • A referral to general Cognitive Behavioural Therapy in Talking Therapies services through your midwife or GP.

What happens if I take part?

Contact 1 – Pre-screening

• A member of the clinical team will approach you about the study at your first trimester scan appointment. If you are interested then they will direct you to a member of the research team.
• If you are happy to take part you will be asked to complete a consent to contact form and an anxiety questionnaire.
• This will take you 5 to 10 minutes to complete.
• A researcher will contact you to let you know if you are eligible or not within 2 working days.

Contact 2 – Screening

• A researcher will contact you to talk through the study and go through a few questions to make sure you are eligible to take part.
• You will be given an opportunity to ask any questions about the trial.
• If you are happy to take part, then you will be asked to complete a consent form.
• You will be randomised to either the intervention or treatment as usual group.

Contact 3 – Baseline

• The baseline visit will take up to 2 hours.
• The researcher will contact you and go through the trial with you and make sure you are happy with all the information.
• You will be asked to complete some questionnaires either online or over the phone with a researcher which will help us understand more about your anxiety.

Contacts 4, 5, 6, 7 – Follow-up visits

• If you were assigned to the intervention group you would have completed the sessions by visit 5.
• For the follow up visits you will be asked to complete questionnaires around your anxiety either online or over the phone with a researcher
• A link to your personalised questionnaires will be sent to you over email.
• These visits will take from an hour to 1.5 hours

Contact 8 – Final visit

• The final visit will take up to 2 hours.
• You will be asked to complete questionnaires around your anxiety either online or with a researcher.
• You and your partner/close supporter will also be asked to be recorded interacting with your baby. We are doing this to look at whether the intervention improves the relationship you have with your baby. The visit can be done in person or remotely through a video call.
• You will be given you a thank you voucher for taking part in the study.

What are the advantages in taking part?

• There is a lack of information about the effectiveness and long-term benefits of a group treatment for antenatal anxiety compared to usual care.
• Regardless of the group you will be randomised into, your input in the clinical trial will contribute to the evidence around what treatment is effective in targeting pregnancy-related anxiety.

What are the risks in taking part?

• We do not expect there are any disadvantages or risks to you.
• All the sessions will be arranged at a time to suit you and your partner.
• You may feel anxious before or tired after taking part in the sessions or while completing the questionnaires, but we will do everything we can to minimise or prevent this.

Who has reviewed the study?

The study has been reviewed and approved by the National Research Ethics Service (NRES) Committee (South West – Cornwall & Plymouth Research Ethics Committee). It is sponsored by Devon Partnership Trust and funded by the National Institute of Health Research.

What will happen to the results?

The findings of the study, and anonymised quotes will be published in academic journals, funding reports and presented at research meetings and conferences. However, your name will not be used in any written or verbal reports arising from the research. If you are interested in obtaining a summary of the results, or a copy of any publication(s), please let the study researcher know, and we can arrange to send a copy to you when the summary and/or other publication(s) are available.

Will my information be kept confidential?

Before you consent to the trial we will ask if it is okay for us to share your decision to participate with your GP and midwife. The only information that will be passed onto the GP and midwife would be that screened positive to antenatal anxiety. All data collected during the trial will be kept confidential. The only time we would have to break confidentiality is if there was a safe guarding concern. We would then have to notify the relevant people, which may include your GP or midwife.

How will we use information about you?

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?

You can find out more about how we use your information

• at www.hra.nhs.uk/information-about-patients/
• by asking one of the research team
• by sending an email to antoinette.davey@nhs.net
• by sending an email to the Sponsor data protection officer (dpt.saferinformation@nhs.net)

Who can I contact for independent research information?

If you have any questions about being in a research study, you can contact the Trust’s Patient Advice Liaison Service (PALS). They will give you advice about who you can talk to for independent advice.

Will I get paid for participating?

At the end of the study you will receive a thank you voucher for taking part in the study. You will not be paid during the course of the study for any travel expenses if the intervention sessions take place in person.

Who can I contact for further information about taking part?
You can contact the trial manager Antoinette Davey on Antoinette.davey@nhs.net or ACORN-II@exeter.ac.uk

What if something goes wrong?

If you wish to complain, or if you have any concerns about any aspect of the way you have been approached or treated during the course of the ACORN-II trial, by University of Exeter, University of Cambridge, University of Birmingham, Manchester University, or by NHS employees, the normal complaints mechanisms will be available to you.

If you have specific concerns or questions about the study, you can contact the study researcher (see contact details below) or the Chief Investigator at the University of Exeter (Professor Heather O’Mahen – telephone: 01392 724651 or e-mail: H.OMahen@exeter.ac.uk).

What if I want to complain?

If you are not happy with the way you have been treated by an NHS service, you have the right to complain, have your complaint investigated, and be given a full and prompt reply. You can ask the organisation (e.g. GP practice, hospital or NHS Trust) for a copy of its complaints procedure, which will explain how to make a complaint. Your first step will normally be to write or speak to the health professional (e.g. the nurse or doctor) concerned, or to the complaints manager within their organisation. Alternatively, you can contact the relevant commissioning body such as the NHS England or a local Clinical Commissioning Group (CCG). You may also wish to seek advice from your local Patient Advice and Liaison Service (PALS) – all hospitals have a PALS Officer. More information about the NHS Complaints Procedure can be found on the NHS Choices website at: http://www.nhs.uk/choiceintheNHS/Rightsandpledges/complaints/Pages/AboutNHScomplaints.aspx

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Terms explained

Antenatal

• The period of time during pregnancy.

Postnatal

• The period of time after the baby is born, post pregnancy.

Anxiety

• It is a feeling of fear, worry, and uneasiness.

Feasibility study

• A study to evaluate whether or not a project plan could be successfully carried out testing an intervention.

Randomisation

• Randomisation means that a group of people are split into two groups at random; one group is given one intervention (CALM) and the other is given a different intervention (treatment as usual).
• For this trial, we will measure how each group is doing and see if one group has achieved its supposed outcome any better.
  Trial Intervention
• A trial intervention is designed to answer specific questions about the intervention.
• The trial intervention is defined as a treatment for a specific condition.
• The purpose of a trial is to see whether the intervention improves health.

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Participant Privacy Information

YOUR RIGHTS
Your usual statutory rights to access, change or move your information are limited, because of exceptions applicable to some types of research, and also because we need to manage your information in specific, lawful ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

LEGAL BASIS
As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

CONTACT US
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.

How to contact us

If you have any questions about this study, please contact ACORN-II@exeter.ac.uk