title: Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial.
abstract: 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.
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Kylee
authors.initials: K
authors.lastname: Trevillion
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Jill
authors.initials: J
authors.lastname: Domoney
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Pickles
authors.affiliation: Florence Nightingale Faculty of Nursing and Midwifery, Division of Women's Health, King's College London, London, UK.
authors.forename: Debra
authors.initials: D
authors.lastname: Bick
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Margaret
authors.initials: M
authors.lastname: Heslin
authors.affiliation: University of Melbourne and Parent-Infant Research Institute, Melbourne, Australia.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Milgrom
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Mycroft
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Carmine
authors.initials: C
authors.lastname: Pariante
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ryan
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Myra
authors.initials: M
authors.lastname: Hunter
authors.affiliation: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. louise.howard@kcl.ac.uk.
authors.forename: Louise Michele
authors.identifier: 0000-0001-9942-744X
authors.initials: LM
authors.lastname: Howard
mesh_terms: D002985:Clinical Protocols; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D008603:Mental Health; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011295:Prenatal Care; D018401:Sample Size
keywords: Depression; Guided Self-Help; Pregnancy; Randomised controlled trial