title: Expanding care for perinatal women with depression (EXPONATE): study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care.
abstract: BACKGROUND
  Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant. In Nigeria, as in many other low- and-middle-income countries (LMIC), perinatal depression usually goes unrecognized and untreated. The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones.
  
  
  METHODS
  A pragmatic two-arm parallel cluster randomized controlled trial was designed. The units of allocation are the primary maternal care clinics. Thirty eligible and consenting clinics were randomized but, due to problems with logistics, 29 eventually participated. Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale (EPDS score ≥12), absent psychosis or bipolar disorder, and not actively suicidal were recruited into the trial (N = 686). Midwives in the intervention arm were trained to deliver psychoeducation, problem solving treatment, and parenting skills. Eight weekly sessions were delivered following entry into the study. Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms. Clinical support and supervision, delivered mainly by mobile phone, were provided by general physicians and psychiatrists. Automated text and voice messages, also delivered by mobile phones, were used to facilitate patient compliance with clinic appointments and 'homework' tasks. Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression. Assessments are undertaken at baseline, 2 months following recruitment into the study and 3, 6, 9 and 12 months after childbirth. The primary outcome is recovery from depression (EPDS < 6) at 6 months. Secondary outcomes include measures of disability, parenting skills, maternal attitudes, health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley's Scales.
  
  
  CONCLUSIONS
  To the best of our knowledge, this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa.
  
  
  BACKGROUND
  Trial is registered with the ISRTCN registry at isrtcn.com; Trial number ISRCTN60041127 . Date of registration is 15/05/2013.
authors.affiliation: Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. oye_gureje@yahoo.com.
authors.forename: Oye
authors.initials: O
authors.lastname: Gureje
authors.affiliation: Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. bibideji@yahoo.com.
authors.forename: Bibilola Damilola
authors.initials: BD
authors.lastname: Oladeji
authors.affiliation: Centre for Global Mental Health, London School of Hygiene and Tropical Medicine, London, UK. ricardo.araya@lshtm.ac.uk.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Araya
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Nottingham, UK. alan.montgomery@nottingham.ac.uk.
authors.forename: Alan A
authors.initials: AA
authors.lastname: Montgomery
authors.affiliation: Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria. lola_kola2004@yahoo.com.
authors.forename: Lola
authors.initials: L
authors.lastname: Kola
authors.affiliation: Division of Social and Transcultural Psychiatry, McGill University Culture and Mental Health research unit, Jewish General Hospital, Montréal, Canada. laurence.kirmayer@mcgill.ca.
authors.forename: Laurence
authors.initials: L
authors.lastname: Kirmayer
authors.affiliation: Division of Social and Transcultural Psychiatry, McGill University Culture and Mental Health research unit, Jewish General Hospital, Montréal, Canada. phyllis.zelkowitz@mcgill.ca.
authors.forename: Phyllis
authors.initials: P
authors.lastname: Zelkowitz
authors.affiliation: Division of Social and Transcultural Psychiatry, McGill University Culture and Mental Health research unit, Jewish General Hospital, Montréal, Canada. Danielle.groleau@mcgill.ca.
authors.forename: Danielle
authors.initials: D
authors.lastname: Groleau
mesh_terms: D000328:Adult; D040421:Cell Phone; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D008880:Midwifery; D009549:Nigeria; D011181:Postnatal Care; D011247:Pregnancy; D011248:Pregnancy Complications / Q000523:psychology* / Q000628:therapy*; D011295:Prenatal Care; D011320:Primary Health Care