Pregnancy and Wellbeing Study (PAWS)

ISRCTN	ISRCTN72346869
DOI	https://doi.org/10.1186/ISRCTN72346869
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester (UK)
Funder	National Institute for Health Research (NIHR) CLAHRC, Leicestershire, Rutland and Northamptonshire (UK)

Submission date: 13/10/2011
Registration date: 02/12/2011
Last edited: 20/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The implications of depression in the perinatal period are considerable for the well-being, safety and the development of the baby, with depression in mothers associated with adverse effects on child health. Antenatal depression is the main predictor of postnatal depression and women may be more depressed in late pregnancy than at any other perinatal time point. There are few studies of antenatal interventions to prevent postnatal depression and none to prevent depression assessed before childbirth.
The purpose of the study will be to evaluate the feasibility, and effectiveness of training community mid wives (CMWs) in a psychological approach to prevent perinatal depression antenatally. Randomly selected CMWs will receive training on a psychological approach and will then subsequently deliver an enhanced delivery of care to consenting women on their caseload.

Who can participate?
300 women will be involved in the study from the Leicestershire and Rutland region.

What does the study involve?
This is a pilot study before a full scale study can take place. The pilot study will address questions of resources needed for recruitment, cognitive behavioural approach (CBA) therapists and midwife involvement. Participants will be asked to complete a number of research questionnaires throughout the study.

What are the possible benefits and risks of participating?
There are no risks to the participants

Where is the study run from?
Leicestershire, Northamptonshire and Rutland

When is the study starting and how long is it expected to run for?
September 2010 to September 2012

Who is funding the study?
The study is funded by the The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care - Leicestershire, Northamptonshire and Rutland (NIHR CLAHRC for LNR)

Who is the main contact?
Prof. Terry Brugha
tsb@le.ac.uk

Contact information

Prof Traolach Brugha
Scientific

Department of Health Sciences
College of Medicine, Biological Sciences and Psychology
University of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Phone	+44 (0)116 258 4395
Email	tsb@le.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot study of a cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Psychological approach for preventing perinatal depression antenatally pilot of a cluster randomised controlled trial of community midwifery training
Study acronym	PAWS
Study objectives	Can training of community midwives (CMWs) in a psychological approach to their delivery of care, enhance their standard delivery of care and subsequently, prevent antenatal depression? We hypothesis that the training of CMWs, in a psychological approach to their delivery of care, we will help prevent antenatal depression and improve the mental health of pregnant women. This pilot is not powered to answer this question definitively. The purpose of the study will be to evaluate, in a pilot of a cluster randomised controlled trial (CRCT), the feasibility, and effectiveness of training CMWs in a psychological approach to prevent perinatal depression antenatally, based on the comparison of community midwife care as usual (standard care) with enhanced assessment and psychological support by CMWs. The study findings, including a qualitative evaluation, will help to inform planning for a larger randomised controlled clinical trial. A planned interim analysis of this pilot study will be conducted, to enable the planning of recruitment to a multicentre study with sufficient power.
Ethics approval(s)	Trent Research Ethics Committee, 03/06/2010, ref: 10/H0405/39
Health condition(s) or problem(s) studied	Pregnancy
Intervention	Control group: The control group CMWs will continue to provide community midwife care as usual, encompassing the breadth of care currently provided by community midwives. They will be only required to hand out the pilot study information packs at antenatal booking clinics and to complete a womans service contact and activity participant log for each woman consenting to take part in the study. Intervention group: The intervention CMWs will receive a total of seven days of training. They will attend a one day training module on the assessment of women, recognising antenatal depression, and monitoring symptoms of depression. Training will include standardised procedures for administering the EDS (Edinburgh Postnatal Depression Scale) questionnaire covering the use of probe questions to evaluate the clinical importance of the results of the self-completion questionnaire. The intervention CMWs will also attend a six day training module on the development of midwives skills in the Cognitive Behavioural Approach (CBA) to the delivery of care to prevent antenatal depression, to be used with all intervention group women who have agreed to take part in the pilot study. CBA incorporates cognitive behaviour therapy (CBT) principles and skills which will be delivered by qualified cognitive-behavioural psychotherapists who are based in local National Helath Service (NHS) psychological therapy teams. CMWs will be supported to tailor their care to the womans needs and preferences. Manuals will be based on materials used in Psychological interventions for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial (PoNDER)2, a cluster randomised conrolled trial designed to compare the effectiveness and cost of postnatal health visitor training in depression recognition and psychological care, developed and provided for CMWs in the intervention groups; CMWs will also be given active feedback and guidance on practice in their use by their trainer. Training will focus primarily on depression but will acknowledge the frequent co-existence of symptoms of general anxiety.
Intervention type	Other
Primary outcome measure(s)	1. The proportion of Edinburgh Depression Scale (EDS) negative women (clinic researcher administered) at study entry, identified at 34-weeks as EDS (clinic researcher administered) positive (EDS ≥12) 2. The primary comparison will be between all EDS negative women who were under the care of CMWs randomised to provide the intervention, versus all EDS negative women under the care of CMWs who were randomised to provide CMW care as usual 3. To assess the feasibility of the study, randomly selected intervention group women, having completed the 34 week pilot outcome, will also be invited to take part in qualitative evaluations of the pilot with an experienced researcher. All intervention midwives will take part in a confidential focus group
Key secondary outcome measure(s)	1. The proportion of Edinburgh Depression Scale (EDS) positive women (clinic researcher administered) at study entry, identified at 34-weeks (clinic researcher administered) as remaining EDS positive (EDS ≥12), comparing intervention with control women 2. In all participating women the mean EDS score, state anxiety with the STAI, SF-12 score and the Agnew scale at 34 weeks of pregnancy, comparing intervention with control women 3. Qualitative information on study feasibility including participation of CMWs and study women
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	300
Key inclusion criteria	All pregnant women on the caseload of participating community midwives, who are also: 1. Registered by the 18th week of pregnancy 2. Over 18 years of age 3. Able to give informed consent 4. Residing in the UK and intend to remain there 6 months after the birth of the baby 5. Able to read and fully comprehend English
Key exclusion criteria	1. Not able to give informed consent for any reason 2. Not a resident of the UK or will not remain in the UK for 6 months after the birth of the baby 3. Unable to fully comprehend and read English 4. Women who are currently in receipt of treatment from specialist mental health services
Date of first enrolment	01/09/2010
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Leicester

Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Results article	results	01/01/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/09/2016: Publication reference added.