Clinical Trial

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

Study acronym: IPMH
Recruiting
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Summary
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-06-07; most recent amendment 2025-12-03.
Status change: Not Yet Recruiting → Recruiting 2025-03-21
Trial Details
NCT Number NCT06456307
Lead Sponsor Kenyatta National Hospital
Collaborators: National Institute of Mental Health (NIMH)
Conditions Depression, Anxiety, Antenatal Depression, Postnatal Depression
Enrollment 2,970 participants
Start Date 2025-02-17
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-10