title: A cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol.
abstract: BACKGROUND
  Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care.
  
  
  METHODS
  48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother-infant relationship and intimate partner relationship, and healthcare costs and outcomes.
  
  
  BACKGROUND
  Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12613000506796. UTN: U1111-1125-8208.
authors.affiliation: Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Heather
authors.initials: H
authors.lastname: Rowe
authors.affiliation: Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Karen
authors.initials: K
authors.lastname: Wynter
authors.affiliation: Faculty of Business and Economics, Centre for Health Economics, Monash University, Clayton, Victoria, Australia.
authors.forename: Paula
authors.initials: P
authors.lastname: Lorgelly
authors.affiliation: Judith Lumley Centre, La Trobe University, Melbourne, Victoria, Australia.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Amir
authors.affiliation: Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.
authors.forename: Sanjeeva
authors.initials: S
authors.lastname: Ranasinha
authors.affiliation: Department of Education and Early Childhood Development, Melbourne, Victoria, Australia.
authors.forename: Jenny
authors.initials: J
authors.lastname: Proimos
authors.affiliation: Parenting Research Centre, East Melbourne, Victoria, Australia.
authors.forename: Warren
authors.initials: W
authors.lastname: Cann
authors.affiliation: Centre for Community Child Health, The Royal Children's Hospital, Parkville, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia, Parkville, Victoria, Australia.
authors.forename: Harriet
authors.initials: H
authors.lastname: Hiscock
authors.affiliation: School of Psychology, Faculty of Science, Technology and Engineering, La Trobe University, Bundoora, Victoria, Australia.
authors.forename: Jordana
authors.initials: J
authors.lastname: Bayer
authors.affiliation: Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Joanna
authors.initials: J
authors.lastname: Burns
authors.affiliation: Faculty of Business and Economics, Centre for Health Economics, Monash University, Clayton, Victoria, Australia.
authors.forename: Jemimah
authors.initials: J
authors.lastname: Ride
authors.affiliation: Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Irene
authors.initials: I
authors.lastname: Bobevski
authors.affiliation: Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Fisher
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D019546:Couples Therapy / Q000379:methods*; D019052:Depression, Postpartum / Q000517:prevention & control* / Q000523:psychology; D005260:Female; D006801:Humans; D011614:Psychotherapy, Brief / Q000379:methods*; D016896:Treatment Outcome; D014739:Victoria
keywords: MENTAL HEALTH; PREVENTIVE MEDICINE; PRIMARY CARE; PUBLIC HEALTH