Extrait

Background and study aims We conducted a study to compare cognitive behaviour therapy (CBT) plus usual care with usual care. The study aimed to help women with depression recover before the end of pregnancy and to look at the feasibility of conducting a full trial. Therefore, we tested procedures for recruiting, assessing and randomly allocating women to treatment, and to assess if it was possible to provide therapy before the end of pregnancy. We also tested how well the 3 depression screening questions used by midwives at booking appointments worked. Who can participate? Pregnant women in North Bristol aged 16 or over and between 8 and 18 weeks pregnant were able to take part. What does the study involve? Women who agreed to be contacted were asked to complete some questionnaires, including a detailed assessment of depression. Women were randomly allocated either to the CBT group plus usual care or usual care. Those who received CBT were visited at home by the therapist for up to 12 sessions. Follow up assessments were repeated once more during pregnancy and again postnatally. Women who reported no low mood symptoms on the 3 depression screening questions were asked to take part in a validation study. Women who agreed were asked to complete some questionnaires. What are the possible benefits and risks of participating? The benefit of taking part in this study meant that the results could help midwives and GPs in the future to decide on the best treatment for women who experience low mood during their pregnancy. Women may have found some of the questions asked during their assessment upsetting, but the researchers were able to offer support during the appointment, but they could also contact the midwives or GPs who normally provide care for them if necessary. There were no other disadvantages or risks associated with taking part in the study. Where is the study run from? The University of Bristol (UK). When is the study starting and how long is it expected to run for? The study started recruiting pregnant women in North Bristol in May 2010 until February 2011. Follow up of trial participants continued until June 2011. Who is funding the study? The National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme. Who is the main contact? Dr Jonathan Evans [email protected]

Critère d'inclusion

• Depression during pregnancy

Liens

• ictrp
• isrctn