Project details

Summary

What is the study about? 

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.

What are you trying 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 does taking part involve?

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.

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.

You will be randomised to either the intervention or treatment as usual group. 

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).

Treatment as usual: 

Treatment as usual (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.
  

The researcher will contact you and ask you to complete some questionnaires either online or over the phone to help us understand more about your anxiety, going from before your treatment (baseline), during and after your treatment. In the final visit, 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.

Who is it for?

We are approaching all pregnant women/birthing persons aged 18 and above at their first trimester scanning appointment to be screened for anxiety.

Why is it important? 

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.

How can I find out more?

You can find out more information about taking part in this study by downloading the key documents at the top of this page. You can also visit the study's website here.   

If you are interested in taking part in this study, or have questions for the research team, click the button below to email us:

Email the research team