A study to support women with mild to moderate anxiety in pregnancy

ISRCTN	ISRCTN12834758
DOI	https://doi.org/10.1186/ISRCTN12834758
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	294369
Protocol serial number	21OB011, IRAS 294369, CPMS 51712
Sponsor	Nottingham University Hospitals NHS Trust
Funders	Health Education England, National Institute for Health Research

Submission date: 15/03/2022
Registration date: 18/03/2022
Last edited: 28/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Each year in the UK about 750,000 women use midwifery services, and 14% will experience symptoms of anxiety. Anxiety disorders are associated with postnatal depression, low birthweight, premature birth and developmental and behavioural problems in children. For women with mild-moderate anxiety, psychological support may help reduce anxiety and prevent an escalation of symptoms. A preliminary study (RAPID-1) was completed in 2017. The intervention design followed the Medical Research Council (MRC) framework and was informed by psychological theory, systematic review evidence and expert and public involvement. RAPID-1 was the first midwife-led intervention to be evaluated for pregnant women with symptoms of mild to moderate anxiety. The preliminary study demonstrated the intervention could be integrated within routine maternity care and women considered that they benefitted from participating. The aim of the RAPID-2 study is to test the feasibility of conducting a trial to examine the effectiveness of a midwife-facilitated intervention for pregnant women with symptoms of mild to moderate anxiety

Who can participate?
Women aged 18 years and over, about 16-20 weeks pregnant with no previous births, with symptoms of mild to moderate anxiety, attending for accessing maternity care in the participating NHS Trusts

What does the study involve?
Women are randomly allocated to receive or to not receive the RAPID support. Women receiving RAPID support will be invited to attend discussion groups once per fortnight over 12 weeks. A midwife and maternity support worker will help run the groups. Women will also have a choice of self-help materials to use between groups. Groups will be held online or in healthcare centres and women will be able to speak one-to-one with a midwife if they wish. Women will be asked to complete questionnaires about their feelings and their situations. Women not allocated to the RAPID support will be asked to complete questionnaires about their feelings and their situations. Nothing that can identify women as individuals will be reported and names will not be used. Women will be involved in the study for around 18 weeks in total.

What are the possible benefits and risks of participating?
The researchers cannot promise the study will help the participants but the information from this study may help other women in the future. It is unlikely that there will be any drawbacks in taking part, although women may sometimes feel upset when discussing their feelings. The researchers ask that women participating in groups only share things that they are comfortable sharing. The midwife leading the group will be available to discuss any concerns.

Where is the study run from?
Nottingham University Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
April 2019 to July 2023

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Kerry Evans, kerry.evans1@nottingham.ac.uk

Contact information

Dr Kerry Evans
Principal investigator

Nottingham University Hospitals Trust
Research and Innovation
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0000-0002-1381-9168
Phone	+44 (0)7596783920
Email	kerry.evans1@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre feasibility open pragmatic cluster randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	The RAPID 2 study: Reducing Anxiety in Pregnancy: Intervention Development phase 2. A feasibility study of a midwife-facilitated supportive intervention versus standard care for nulliparous pregnant women with symptoms of mild to moderate anxiety
Study acronym	RAPID 2
Study objectives	The aim of the study is to test the feasibility of conducting a trial to examine the effectiveness of a midwife-facilitated intervention compared with usual care for pregnant women with symptoms of mild to moderate anxiety
Ethics approval(s)	Approved 11/03/2022, East Midlands - Derby Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 1048211; derby.rec@hra.nhs.uk), ref: 22/EM/0018
Health condition(s) or problem(s) studied	Pregnant women with symptoms of mild to moderate anxiety
Intervention	Clusters will be randomly allocated to intervention groups and control groups within each stratum. Randomisation will be performed by the statistical team at the Derby Clinical Trials Support Unit. Random allocation will be conducted by Derby Clinical Trials Support Unit using a web-based system. Neither the cluster site, participant nor the facilitator can be blinded to allocation status. Participants in the intervention group will receive treatment as usual (as described for control group) plus the RAPID 2 intervention, comprising three components: 1. One-to-one pre-group meeting with the midwife facilitator. Facilitators will receive training to help them support women with symptoms of mild to moderate anxiety in pregnancy and facilitate group sessions. 2. Group discussion sessions facilitated by a midwife and midwifery support worker. Four facilitated groups plus two peer-led groups will take place over a 12-week period (every fortnight). Groups will last approximately 90 minutes. Discussion topics will be suggested and agreed by the group. Individual midwife support will be available before and after groups. 3. A choice of self-help materials to be accessed between groups. The choice of materials is based on service user preferences and relevance in a UK healthcare context. Materials cover cognitive skills, mindfulness meditation and/or relaxation. Control group participants will receive usual maternity care (treatment as usual, TAU). The exact component of usual antenatal care varies across settings, but always includes routine midwife appointments and access to obstetric and specialist perinatal mental health services, as required. Components which may not be available in all sites include emotional or social support interventions and low-level psychological services such as IAPT. Control group participants will be asked to complete the same pre-intervention, mid-point and post-intervention data collection questionnaires as the intervention group and will be offered the same choice to complete questionnaires digitally or by hand. The duration of participant involvement will be 18 weeks. The intervention duration is 12 weeks.
Intervention type	Behavioural
Primary outcome measure(s)	1. Recruitment, retention and completion rates measured at recruitment using the: 1.1. The number of women accessing the site and completing eligibility screening 1.2. The number of eligible women 1.3. The number of women who consent to participate 4. Women’s and facilitators’ views on participating in the intervention and the acceptability and experiences of random allocation to a usual care group, assessed using face-to-face semi-structured interviews conducted in the community, women’s homes or via video conferencing platforms (women’s preference and following local and national guidance re: COVID-19 following Sponsors Standard Operating Procedures) at post-intervention (follow-up)
Key secondary outcome measure(s)	Measured at baseline, 7 and 13-14 weeks: 1. Anxiety assessed using the Generalised Anxiety Disorder scale (GAD-7) 2. Anxiety and depression assessed using the Edinburgh Postnatal Depression Scale (EPDS) 3. Pregnancy-related anxiety assessed using the Pregnancy Related Anxiety Questionnaire - Revised (PRAQ-R) 4. Quality of life assessed using the Short-Form Health Survey (SF-12) 5. Social support assessed using the Multidimensional Scale for Perceived Social Support (MSPSS) 6. Service and support use assessed using the Client Service Receipt Inventory (CSRI)
Completion date	31/07/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	200
Total final enrolment	60
Key inclusion criteria	1. Women attending for or accessing maternity care in the study site NHS Trusts at approximately 16-20 weeks of pregnancy 2. Nulliparous pregnant women aged 18 years or older at the time of enrolment (no upper age limit) 3. Self-reported symptoms of mild to moderate anxiety 4. Able to read, write and speak the English language Self-reported symptoms of anxiety: A study website will present potential participants with an example of the GAD-7 scale and advise that women with scores between 3 - 14 are suited to participate in the study. Women will be advised to contact their GP or community midwife if they feel they require further assessment and support (current practice guidelines). Participants with a GAD-7 score of 15 or more will be thanked for their interest and advised that the type of intervention the study is aiming to assess may not be suited to them. A score of 15 or more may indicate severe anxiety (Spitzer et al. 2006) and these women will be advised to contact their GP or community midwife for further assessment and support.
Key exclusion criteria	Pregnant women receiving treatment for a severe and enduring mental health condition
Date of first enrolment	23/02/2023
Date of final enrolment	21/04/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Nottingham University Hospitals NHS Trust - City Campus

Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sherwood Forest Hospitals NHS Foundation Trust

Kings Mill Hospital
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom

Northampton General Hospital

Cliftonville
Northampton
NN1 5BD
United Kingdom

The Dudley Group NHS Foundation Trust

Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		26/10/2022	27/10/2022	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/02/2025: Contact details updated. Total final enrolment added.
28/08/2024: The intention to publish date has been changed from 01/08/2024 to 01/01/2025.
17/04/2024: The intention to publish date has been changed from 01/11/2023 to 01/08/2024.
24/04/2023: The following changes have been made and the plain English summary updated accordingly:
1. The recruitment start date has been changed from 20/06/2022 to 23/02/2023.
2. The recruitment end date has been changed from 15/08/2022 to 21/04/2023.
3. The overall trial end date has been changed from 28/10/2022 to 31/07/2023.
4. The intention to publish date has been changed from 01/06/2023 to 01/11/2023.
27/10/2022: Publication reference added.
11/05/2022: The following changes have been made:
1. The recruitment start date has been changed from 23/05/2022 to 20/06/2022.
2. The recruitment end date has been changed from 18/07/2022 to 15/08/2022.
01/04/2022: Internal review.
17/03/2022: Trial's existence confirmed by East Midlands - Derby Research Ethics Committee.