Extrait

Background and study aims Pregnancy does not appear to be protective against the existing or development of new mental disorders. Depression is the most common antenatal mental disorder and can have a considerable impact upon a woman and her family. To date, there has been no study of mild psychological interventions in the antenatal setting which may be more effective and cost-effective for mild and moderate depression during pregnancy. We therefore propose to modify and evaluate Guided Self Help materials for antenatal depression in women using NHS maternity services. This study aims to get initial evidence on the how effective is the Guided Self Help intervention in improving depressive symptoms and other outcomes (e.g. psychological symptoms after giving birth and quality of life) for women with antenatal depression. Who can participate? Adult pregnant women who are up to 26 weeks pregnant and having depressive symptoms can take part. What does the study involve? Pregnant women experiencing depression will be randomly allocated to either antenatal Guided Self Help (given by an NHS Psychological Wellbeing Practitioner) plus usual care, or to usual care alone. The antenatal Guided Self Help intervention has been modified from existing Guided Self Help materials used in psychological services for the treatment of depression. Modifications include addressing pregnancy-specific worries, and including sections on health issues in pregnancy and planning for parenthood. Women allocated to the this group will be seen for up to eight sessions by a Psychological Wellbeing Practitioner (including an initial assessment session); there will also be a appointment at 12 weeks after delivery. Research measures will be taken from all women before random allocation, after 14 weeks of allocation and at 12 weeks after delivery. Data will also be collected to find out if this method is cost-effective. What are the possible benefits and risks of participating? The opportunity to talk about symptoms with a researcher can be beneficial and, where appropriate, participants will be encouraged to discuss concerns with their midwife and given information on sources of help and support, which may be helpful in managing their situation. Some participants may find that being asked questions about their mental health and wellbeing is sensitive, and the potential for the interview to bring up these feelings is described on the Participant Information Sheet. At the beginning of the interview, participants will be asked if there is anyone they would like the researcher to contact for support if they become distressed. Participants will be closely monitored during interviews for signs for distress and appropriate action will be taken. If there are concerns about the health and wellbeing of participants or their children at the end of the interview, participants will be asked if they would like any of the information they disclosed to be conveyed to their clinic midwife. Where is the study run from? The study is being run from King’s Health Partners (UK) When is the study starting and how long is it expected to run for? October 2014 to June 2017 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Ms Kylee Trevillion [email protected]

Critère d'inclusion

• Topic: Mental Health, Reproductive health and childbirth; Subtopic: Depression, Reproductive Health and Childbirth (all Subtopics); Disease: Depression, Reproductive Health & Childbirth

Liens

• isrctn
• ictrp