A group treatment for antenatal anxiety
| ISRCTN | ISRCTN69012026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69012026 |
| IRAS number | 333463 |
| Secondary identifying numbers | 29369, IRAS 333463, CPMS 60522 |
- Submission date
- 21/09/2023
- Registration date
- 12/02/2024
- Last edited
- 16/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
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 and baby development. Babies of mothers who struggle with anxiety during pregnancy can have more problems with their emotions, behaviours and cognitive development. If the mother’s anxiety continues after the baby is born it can make it difficult for the mother to bond with the baby and provide the kind of care the baby needs. Together, the impact of untreated perinatal mental health problems cost over £8 billion each year in England. Despite the fact that anxiety problems are more common during pregnancy and have many negative effects, 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.
We will test whether CALM 1) improves anxiety in pregnant women during pregnancy; 2) has sustained benefits in the postnatal period, up to a year after the baby is born; 3) improves the relationship the parent has with the child and how the child develops and 4) is cost-effective for the NHS to deliver. We will also interview parents who completed CALM to see which parts helped them the most, and we will ask care providers about the best ways to ensure CALM fits within the NHS.
Who can participate?
Any woman or birthing person over the age of 18 who scores 8 and above on the GAD-7.
What does the study involve?
Eligible participants will be randomised to either receive the intervention and treatment as usual or solely treatment as usual. Those in the intervention will receive a 4-session group based online intervention delivered by healthcare and psychological practitioners. The intervention includes partners or a close support and the group encourages peer support. All participants will be asked to complete questionnaires at 6 timepoints (at the start, 22 and 32 weeks pregnant, 2/6/12 months post birth).
What are the possible benefits and risks of participating?
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. If you do decide to take part, as a thank you gesture we will offer you a voucher.
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.
Where is the study run from?
The Universities of Exeter, Manchester, Cambridge, and Birmingham are leading the recruitment. This trial also has academics from Imperial College London, University of Bath, Anna Freud Centre and Kings College London. It is sponsored by Devon Partnership NHS Trust.
When is the study starting and how long is it expected to run for?
September 2023 to August 2027
Who is funding the study?
National Institute of Health Research - Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Antoinette Davey, antoinette.davey@exeter.ac.uk
Contact information
Public
Devon Partnership Trust
Wonford House
Dryden Road
Exeter
EX2 5AF
United Kingdom
 ORCID ID |
0000-0002-5118-6912 |
|---|---|
| Phone | +44 (0)7828843266 |
| antoinette.davey@exeter.ac.uk |
Principal Investigator
University of Exeter
Faculty of Health and Life Sciences
Psychology Department
Washington Singer Labs
Perry Road
Exeter
EX44QG
United Kingdom
| ORCID ID |
0000-0003-3458-430X |
|---|---|
| Phone | +44 (0)1392724651 |
| H.OMahen@exeter.ac.uk |
Study information
| Study design | Group sequential multi-centre parallel arm individually randomized controlled trial with internal pilot interim monitoring for futility and economic and process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Hospital |
| Study type | Treatment |
| Participant information sheet | 44306_PIS_partners_v1_04Dec2023.pdf |
| Scientific title | ACORN-II: A multi-site randomised COntrolled trial to evaluate the impact of a group tReatment for aNtenatal anxiety |
| Study acronym | ACORN-II |
| Study objectives | The primary objective is to test whether CALM + Treatment as usual (TAU) reduces anxiety in pregnant women relative to TAU alone. We will also assess whether CALM + TAU has sustained benefits up to a year after the baby is born compared to TAU alone. |
| Ethics approval(s) |
Approved 24/01/2024, South West - Cornwall & Plymouth Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8143; cornwallandplymouth.rec@hra.nhs.uk), ref: 24/SW/0013 |
| Health condition(s) or problem(s) studied | Antenatal anxiety |
| Intervention | Potential participants will be screened for anxiety at first-trimester scanning clinics. If individuals score 8 and above on the GAD-7, they will be eligible for the trial. Eligible participants who consent will be randomly allocated on a 1:1 basis to CALM + TAU or TAU only using permuted block randomisation which will be stratified by site and anxiety diagnosis prepregnancy versus de novo antenatal anxiety. Randomisation will be delivered by a web-based randomisation system (integrated within the trial REDCap system). The CALM intervention comprises four 2-hour online group sessions delivered to both the pregnant woman/birthing person and their partner and one 2-hour postnatal reunion. It is delivered by a healthcare and psychological practitioner. The intervention focuses on strategies that: (1) reduce avoidance associated with worry, (2) improve the ability to tolerate uncertainty that contributes to anxious worry in the perinatal period and (3) improve relationship satisfaction through joint communication skills about how to manage worry together. |
| Intervention type | Behavioural |
| Primary outcome measure | Anxiety will be measured using the Generalised Anxiety Disorder -7 PROM at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months. |
| Secondary outcome measures | 1. Antenatal anxiety measured using Pregnancy-Related Anxiety Questionnaire – Revised 2 (PRAQ-R2) at baseline, 22 weeks and 32 weeks 2. Depression using Patient Health Questionnaire-9 (PHQ-9) at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months. 3. Relationship adjustment measured using Revised Dyadic Adjustment Scale (DAS) at baseline, 22 and 32 weeks pregnant. 4. Health related quality of life measured using EuroQol-5 Dimensions-5 Level (EQ-5D-5L) at baseline, 22 & 32 weeks pregnant, and postnatally at 3, 6, and 12 months. 5. Service use measured using Adult Service Use Schedule (AD-SUS) at baseline, 32 weeks pregnant and 12 months postnatal. 6. Infant behaviour and temperament measured using Infant Behavior Questionnaire – Revised (IBQ-R) at 6 months postnatal. 7. Perceptions of childbirth measured using Maternal Perceptions of Support and Control in Birth (SCIB) at 3 months postnatal. 8. Parent and infant interaction measured using 10-minute videoed interaction and coded using the well-validated NICHD parent-infant sensitivity, intrusiveness scales at 12 months postnatal. 9. Social, emotional and behavioural problems in the infant measured using Brief Infant Toddler Social and Emotional Assessment (BITSEA) at 12 months postnatal. 10. Child development measured using Ages and Stages 3rd edition at 12 months postnatal. |
| Overall study start date | 01/09/2023 |
| Completion date | 31/08/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 484 |
| Key inclusion criteria | Pregnant women and birthing persons aged 18+ years who score above clinical threshold (8 or more) (on a standard anxiety screening measure (GAD-7) |
| Key exclusion criteria | 1. Actively suicidal 2. Substance abuse 3. Psychosis 4. Have childbirth-related PTSD (i.e., individuals eligible to receive PTSD treatment in maternal mental health services) 5. Receiving current psychological treatment for anxiety at baseline interview |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Barrack Road
Exeter
EX2 5DW
United Kingdom
Manchester
M13 0JH
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
London
E9 6SR
United Kingdom
Metchley Park Road
Birmingham
B15 2TG
United Kingdom
Sponsor information
Hospital/treatment centre
Wonford House
Dryden Road
Exeter
EX25AF
England
United Kingdom
| Phone | +44 (0)1392208866 |
|---|---|
| a.wilkie@nhs.net | |
| Website | https://www.dpt.nhs.uk/ |
"ROR" |
https://ror.org/04fkxrb51 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The substantial output from the research will be evidence of whether or not the CALM intervention is a clinically and cost-effective intervention for pregnant women with anxiety that can be delivered jointly by maternity and mental health providers. The outputs from the project will include: • Open access academic papers in high-impact journals • New mental health intervention: updated 5-session CALM clinician and therapist manuals • CALM intervention Implementation guidance for maternity and perinatal mental health services, including implementation top tips. • Therapist training guidance (for perinatal training programmes) with pre-post assessment tools • Therapist CALM competence assessment • Policy documents for: NHSE perinatal and maternity teams and NICE |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 04/12/2023 | 29/01/2024 | No | Yes |
| Participant information sheet | version 1.0 | 07/11/2023 | 29/01/2024 | No | Yes |
Additional files
Editorial Notes
16/07/2025: The date of final enrolment was changed from 30/09/2025 to 31/12/2025.
10/05/2024: Sponsor details updated.
08/03/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 01/03/2024 to 01/05/2024.
2. The recruitment end date was changed from 31/07/2025 to 30/09/2025.
3. St Mary's Hospital, Royal London Hospital and Associated Community Services NHS Trust, Homerton Hospital and Birmingham Women's NHS Foundation Trust were added to the study participating centres.
04/03/2024: Internal review.
29/01/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
