ISRCTN - ISRCTN72346869: Pregnancy and Wellbeing Study (PAWS)

Plain English Summary

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

Trial website

http://www.clahrc-lnr.nihr.ac.uk/pregnancy-and-well-being

Contact information

Type

Scientific

Primary contact

Prof Traolach Brugha

ORCID ID

Contact details

Department of Health Sciences
College of Medicine
Biological Sciences and Psychology
University of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4395
tsb@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Psychological approach for preventing perinatal depression antenatally pilot of a cluster randomised controlled trial of community midwifery training

Acronym

PAWS

Study hypothesis

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

Trent Research Ethics Committee, 03/06/2010, ref: 10/H0405/39

Study design

Pilot study of a cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

01/09/2010

Overall trial end date

30/09/2012

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300 pregnant women will be recruited, with the aim of identifying 230 women with an EDSS score, at their dating scan clinic (approximately the 12th week of pregnancy)

Participant 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

Recruitment start date

01/09/2010

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester (UK)

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) CLAHRC, Leicestershire, Rutland and Northamptonshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data