Perinatal depression Mental and Behavioural Disorders
Conditions
Interventions
This is a multicenter, three-arm, cluster randomized controlled trial. Randomization will be stratified by facility level (primary vs secondary/tertiary) and dominant language (Yoruba, Hausa, Igbo, Ni
Sponsors
Wellcome Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Target population (primary participants): The cRCT will enroll perinatal women receiving antenatal or postnatal care at participating facilities in Rivers State, Nigeria (UPTH Departments of Obstetrics & Gynaecology and Mental Health; UPTH Comprehensive PHC in Aluu; Rumuigbo MPHC; Ozuboko MPHC; Elekahia MPHC; Ozuogba MPHC; Kelsey Harrison Hospital; Obio Cottage Hospital). Inclusion criteria (perinatal women). Perinatal women will be eligible if they: 1. Are =18 years of age 2. Are currently pregnant or =12 months postpartum 3. Have primary fluency in at least one target language (Yoruba, Hausa, Igbo, or Nigerian Pidgin) 4. Own or have reliable access to a smartphone capable of running the PHIA app or WhatsApp interface 5. Are receiving care at a participating clinical site 6. Have the capacity and willingness to provide written informed consent These criteria ensure that participants can engage with PHIA’s digital functions, are within the perinatal risk window, and can be followed within the cluster’s routine care pathways
Exclusion criteria
Exclusion criteria: Perinatal women will be excluded if they: 1. Exhibit active suicidal ideation (endorsement of PHQ-9 item 9) or severe depression (PHQ-9 =20) at screening; such individuals will receive immediate referral to a mental-health professional outside the trial pathway. 2. Have a previous diagnosis of common or severe mental-health conditions (for example, bipolar disorder, schizophrenia, or recurrent major depressive disorder currently under specialist care); 3. Have high-risk pregnancies or significant pregnancy complications requiring intensive or tertiary-level management where PHIA-supported pathways would not be appropriate. 4. Are judged by the clinical team to have cognitive impairment or other conditions that preclude informed consent or reliable participation. These exclusions are justified to protect participants at highest clinical risk, avoid interference with intensive specialist care, and ensure that the cRCT evaluates PHIA in the population for whom task-sharing and digital decision support are most appropriate. Clinicians and HEWs are not primary trial participants for outcome analysis but will be involved as implementers within clusters; their inclusion follows active clinical practice at participating sites and willingness to participate in workflow and usability activities.
Countries
Nigeria
Contacts
Public ContactDaprim Ogaji
Outcome results
None listed