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
Open accessAbstract
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/STUDY DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Trial is registered with the ISRTCN registry at isrtcn.com; Trial number ISRCTN60041127 . Date of registration is 15/05/2013.
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EXPONATE is a stepped care intervention for perinatal depression in Nigeria that uses mobile technology.
“EXPONATE (Expanding Care for Perinatal Women with Depression) is a multicomponent stepped care intervention for perinatal depression in Nigeria supported with mobile technology.37”
From Digital Technology for Building Capacity of Nonspecialist Health Workers for Task Sharing and Scaling Up Mental Health Care Globally (2019) · cites this paper as [37]
Mobile technology was integrated into EXPONATE to provide ongoing monitoring and supervision for community midwives.
“Mobile technology was integrated into the EXPONATE intervention as a way to provide ongoing monitoring and supervision for the midwives.37”
From Digital Technology for Building Capacity of Nonspecialist Health Workers for Task Sharing and Scaling Up Mental Health Care Globally (2019) · cites this paper as [37]
For three of the interventions summarized, large-scale evaluations of effectiveness are currently ongoing.
“Importantly, for three of the interventions using digital technology that we summarized here, large-scale evaluations of effectiveness are currently ongoing (published protocols for these studies were included).25,34,37”
From Digital Technology for Building Capacity of Nonspecialist Health Workers for Task Sharing and Scaling Up Mental Health Care Globally (2019) · cites this paper as [37]
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Self-citation
- Authors
- Gureje, O., Oladeji, B. D., Araya, R., Montgomery, A. A., Kola, L., Kirmayer, L., Zelkowitz, P., & Groleau, D.
- Affiliations
- University of Ibadan (NG)
- London School of Hygiene & Tropical Medicine (GB)
- University of Nottingham (GB)
- Jewish General Hospital (CA)
- Corresponding author
- Gureje, Oye
- ORCID
- Venue
- BMC Psychiatry
- Published
- 2015-06-30
- Volume
- 15
- Issue
- 1
- Pages
- 136-136
- ISSN
- 1471-244X (ISSN-L)
- PMC
- PMC4486135
- OpenAlex
- W2138243996
- Cited by
- 50
- References
- 49
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 8 · 2023: 6 · 2022: 5 · 2021: 8 · 2020: 5 · 2019: 9 · 2018: 2 · 2017: 2 · 2016: 1
- FWCI
- 1.79
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- eScholarship@McGill (McGill) (submittedVersion, cc-by)
- Funders
- Grand Challenges Canada
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
- Health Sciences › Health Professions › General Health Professions › Maternal and Neonatal Healthcare
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- perinatal depression, community midwives, mobile phone intervention, problem-solving therapy, psychoeducation, parenting skills, physician supervision, cost-effectiveness, low- and middle-income countries, Nigeria, infant cognitive development, Edinburgh Postnatal Depression Scale
- MeSH terms
- Adult, Clinical Protocols, Cost-Benefit Analysis, Depression, Female, Humans, Midwifery, Nigeria, Postnatal Care, Pregnancy, Pregnancy Complications, Prenatal Care, Primary Health Care, Cell Phone
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