Pregnancy and Well-being Study (PAWS) - Psychological approach for preventing perinatal depression antenatally - cluster randomised controlled trial of community midwifery training

Principal Investigator: Traolach (Terry) Brugha

Other key staff: Jane Morrell, Pauline Slade, David Clark, John Bankart and Jane Smith

Partners involved: University Hospitals of Leicester NHS Trust, Leicestershire Partnership Trust, NHS Leicester City and NHS Leicestershire County and Rutland

Summary: 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 trials of antenatal interventions to prevent postnatal depression and none to prevent depression assessed before childbirth.

300 women up to 24 weeks pregnant will be involved in the study from the Leicestershire and Rutland region, with their involvement in the study ending when their baby is six months old. This is initially planned as a pilot study, to be completed before going to full trial. The pilot will address questions of resources needed for recruitment, cognitive behavioral approach (CBA) therapists and midwife involvement. Participants will be asked to complete four sets of research questionnaires throughout the study.

Aims:

• To find out if antenatal depression can be prevented by keeping women well

Further information: Service users will be approached for consultation during the proposal preparation stage, to hear their views on the proposed trial and to provide advice throughout the trial as members of the advisory group. If you would like to be involved in this project, or for more information, please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Start date: 09/2010                                                                                                                    Expected end date: 09/2011

Study outcomes:

• The primary outcomes will be the research follow-up Edinburgh Postnatal Depression Score (EPDS), used to indicate the proportion of 35 weeks EPDS positive women who require ongoing support and who are at risk of being clinically depressed
• The secondary outcomes will be the primary care evaluated assessment of Major Depression, using several depression scores

If the pilot is successful it will hopefully lead to a full trial being carried out. If the prevention intervention training format is then shown to be safe and effective, it will be recommended to local NHS commissioners to fund training in CBA and its sustained delivery in all participating community midwife teams.