ACORN II: RCT for antenatal anxiety
Research type
Research Study
Full title
ACORN: A multi-site randomised COntrolled trial to evaluate the impact of a group tReatment for aNtenatal anxiety
IRAS ID
333463
Contact name
Heather O'Mahen
Contact email
Sponsor organisation
Devon Partnership Trust
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Up to a quarter of women struggle with serious anxiety symptoms during pregnancy. Many women will not improve without treatment, with symptoms continuing postnatally and for some, leading to depression. High anxiety during pregnancy is related to negative outcomes in childbirth, baby development and difficulty in bonding with baby. Babies of mothers who struggle with anxiety during pregnancy can have more problems with their emotions, behaviours and cognitive development. 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.
In a feasibility study a 5-session group intervention (CALM) that gives pregnant women tools to manage anxiety, particularly worries about pregnancy was developed and tested. The CALM treatment includes partners or a close support and the group encourages peer support. This current large trial will evaluate whether offering CALM together with usual treatment is more effective for pregnant women who have problems with anxiety, compared to usual treatment on its own. Over an 18-month-period, we will recruit 484 women to the trial from five sites, both urban and rural, that have people from different ethnic and income backgrounds. We will work with community connectors to help engage pregnant women from diverse backgrounds. We will deliver most of CALM online. We will have a tablet loan library (and data) allowance for those who need this.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0013
Date of REC Opinion
24 Jan 2024
REC opinion
Favourable Opinion