Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial

Depression is a common antenatal mental disorder and is associated with an increased risk of adverse effects on the fetus and significant morbidity for the mother; if untreated it can also continue into the post-natal period and affect mother-infant interactions. There has been little research evaluating the effectiveness or cost-effectiveness of antenatal psychological interventions for antenatal depression, particularly for mild to moderate disorders. International guidelines recommend a stepped care approach starting with Guided Self Help, and the aim of this exploratory trial is to investigate Guided Self Help modified for pregnancy. The DAWN trial is an exploratory randomised controlled trial of the effectiveness and cost-effectiveness of antenatal Guided Self Help, modified for pregnancy and delivered by National Health Service Psychological Wellbeing Practitioners. Antenatal Guided Self Help, in addition to usual care, is compared with usual care for pregnant women diagnosed with mild to moderate depression and mixed anxiety and depression, using the Structured Clinical Interview for DSM-IV Disorders. Modifications for pregnancy include perinatal mental health training, addressing pregnancy-specific worries and including sections on health issues in pregnancy and planning for parenthood. Women allocated to Guided Self Help will be seen for up to eight sessions by a Psychological Wellbeing Practitioner (including an initial assessment session); there will also be an appointment at 12 weeks after delivery. Research measures including the Edinburgh Postnatal Depression Scale (primary outcome) and other measures of depression, anxiety, quality of life and service use will be collected from women before random allocation, 14 weeks after random allocation and at 12 weeks after delivery. Potential psychological mechanisms of the intervention will be explored using the Pregnancy-Related Thoughts Questionnaire and the Metacognitive Awareness Questionnaire. The DAWN trial is the first exploratory trial to investigate the efficacy of antenatal Guided Self Help for pregnant women with mild to moderate depression meeting DSM-IV diagnostic criteria. Recruitment started January 2015 and is expected to be completed by July 2016. ISRCTN registry: ISRCTN83768230 . Registered on 8 August 2014.