Gureje 2019 (EXPONATE).

Study characteristics
Methods	Study design: CRCT. Unit of allocation: maternal care clinics   Duration of study: 18 June 2013 and 11 December 2015
Participants	Country: Nigeria  Income classification: lower‐middle income   Geographical scope: study was conducted in Oyo State in southwestern Nigeria. Nine local government areas (4 urban and 4 rural) were randomly selected for the study   Healthcare setting: PC facility: maternal care clinics  Mental health condition: perinatal MD  Population (mention whether patient, carer, or dyad)  1. Age: 16 to 45 years   2. Gender: female   3. Socioeconomic background: mean education 10.6 years (3.1 SD)  4. Inclusion criteria a. Spoke Yoruba b. Scored ≥ 12 on the Edinburgh Postnatal Depression Scale (EPDS) c. Confirmed presence of major depression according to DSM‐IV (1994) criteria d. Signed informed consent e. Were going to be available in the study area up to 12 months after childbirth 5. Exclusion criteria  a. Immediate need for medical attention b. Actively suicidal c. Presence of bipolar or psychotic disorder d. Unlikely to be in the neighbourhood in the following 12 months
Interventions	Stated purpose: to determine whether an intervention package consisting of primary care worker‐administered problem‐solving treatment delivered within a stepped‐care approach would be more effective than enhanced care as usual for alleviating perinatal depression 6 months after childbirth INTERVENTION: high‐intensity treatment (HIT) (n = 379)  Delivered by: PHP and LHW Title/name of PW and number: PHWs: primary maternal care providers (non‐physician primary care providers and midwives who have been trained as nurses, community health officers, and community health extension workers) 1. Selection: clinics offered full maternal and child health services and provided explicit consent to participate. One clinic was excluded because the staffing profile was too thin to permit effective participation 2. Educational background: minimum of 2 to 3 years post secondary education and certified by respective boards  3. Training: initial 3‐day training and 2‐day top‐up training (1 month later)  4. Supervision: ongoing structured support and supervision from primary care physicians who, in turn, could consult with a psychiatrist when needed       5. Incentives/ remuneration: not specified  Intervention details (according to PHW/CWs and whether aimed at carers and/or patients)  1. Duration/frequency: step 1 comprised 8 sessions of psychological interventions, delivered weekly in the antenatal period. Step 2 commenced 6 weeks after delivery, during the mother’s routine postnatal visit. Depending on participants’ EPDS scores (< 12 or ≥ 12), providers delivered 4 fortnightly top‐up sessions of the PST or 8 weekly intervention sessions. At completion of step 2, participants who still had EPDS scores ≥ 12 proceeded to step 3, in which they were re‐assessed by the community physician with a view to initiate pharmacotherapy, in addition to continuing with the psychological intervention or referral to a specialist service. Each session of the psychological intervention lasted approximately 30 to 45 minutes   2. Content of intervention (by types of health workers and per patients/carers): in addition to enhanced usual care (see below), providers offered stepped‐care treatment, using a manualised psychological intervention package, the core component of which was a locally adapted form of problem‐solving treatment (PST) for primary care. With this intervention, the patient is guided through a step‐by‐step process of breaking down current psychosocial stressors and then exploring and trying out options for their resolution, which includes using personal resources and available social support. Mothers in the HIT arm of the study also received parenting skills training    CONTROL: enhanced care as usual (low‐intensity treatment) (n = 197) PMCP in the low‐intensity treatment (LIT) arm received a 1.5‐day training on use of the mhGAP – Intervention Guide (mhGAP‐IG) ‐ and were given copies of the mhGAP‐IG, as well as a manual describing the nature and standard treatment approaches for perinatal depression. Providers delivered the intervention to participants by using the basic specifications of mhGAP‐IG ‐ psychoeducation, addressing current psychosocial stressors and reactivation of social network. No structured sessions were stipulated, and no stepped‐care procedure was specified; number/frequency of visits and content of psychosocial interventions were determined at the discretion of the PMCP   CO‐INTERVENTIONS: none
Outcomes	Patients  1. EDPS 2. Remission from depression at 6 months post partum, defined as EPDS score < 6* 3. WHODAS 2.0  Carers  None  Process/health workers None  Economic outcomes None (asterisk for study's primary outcomes; star: outcomes that we have not reported in this review)  Time points post intervention: baseline, 0 to 2 months (6 months postpartum), 6 to 8.5 months (12 months postpartum)
Notes	Source of funding: Grand Challenges Canada (0082‐04)   Notes on validation of instruments (screening and outcomes): all instruments were validated   Additional information: Gureje O, Oladeji BD, Araya R, Montgomery AA, Kola L, Kirmayer L, Zelkowitz P, Groleau D. 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. BMC Psychiatry 2015;15:136. Declaration of interests ‐ none Handling the data: as per footnotes in data and analysis  Prospective trial registration number: trial is registered with the International Standard Randomised Controlled Trials Number Registry (http://www.isrctn.com/isrctn) under trial number ISRCTN60041127
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation was conducted by one of the authors (A.A.M.), using anonymous codes for clinics and local government areas provided by other members of the research team Randomisation was conducted using codes; therefore sufficient for random sequence generation and considered low risk
Allocation concealment (selection bias)	Low risk	Considering that allocation concealment and selection bias could be a problem in cluster‐randomised trials, where all participants are not consented and recruited prior to allocation of clusters, consecutive attendees at selected MCCs were invited to participate by trained research staff while waiting to see the midwife. They were briefly educated about perinatal depression and were invited to take the screening interview. Those who agreed were screened with the Edinburgh Postnatal Depression Scale (EPDS) Allocation was conducted by one of the authors (A.A.M.), using anonymous codes for clinics and local government areas provided by other members of the research team Allocation was concealed and was adjusted for clustering
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and interventionists were not blinded; however, this is unlikely to have influenced outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	"All outcome assessments were conducted ... by experience research interviewers... were not involved in participant's recruitment and who were blind to the participant's treatment".
Baseline outcome measurements similar	Unclear risk	No baseline measure for EPDS; it is unclear whether these were different at the start; baseline measures for WHODAS are similar
Baseline characteristics similar?	Unclear risk	Variation in cluster size was not ignorable when design effect was estimated Imbalance in the ratio of women recruited at around 1.9 in favour of the HIT arm Significant differences in baseline characteristics (different cluster size and numbers recruited between HIT and LIT arms; these were not adjusted for; however baseline characteristics were similar. unclear effect)
Incomplete outcome data (attrition bias) Efficacy data	Low risk	In view of the high follow‐up rate, the main approach to analysis was modified intention‐to‐treat at the individual level, that is, analysis according to randomised group regardless of adherence to allocation and without imputation of missing outcome data High follow‐up rate Any missing outcome data were adjusted for in analyses
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Unclear risk	Only 3 of 6 deaths explained; not sure about the 3 unaccounted for
Protection against contamination	Unclear risk	Although interventions were conducted in different clinics by own primary care provider, it is unclear whether there was contamination between groups
Selective reporting (reporting bias)	Low risk	All outcomes planned in the protocol were reported in the results section
Other bias	Low risk	None were detected