Recruiting

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

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…

ClinicalTrials.gov IDNCT06456307
PhaseNA
Enrollment2970
SponsorKenyatta National Hospital
Age14 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Depression, Anxiety, Antenatal Depression, Postnatal Depression

About this study

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.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Pregnant and ≥28 weeks gestation * Attending ANC care at the facility * ≥14 years old * Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3) * Willing to return to the MCH and PMTCT clinic for study visits Exclusion Criteria: * Less than 28 weeks gestation * Any woman at high risk of self-harm based on a study self-harm assessment protocol, * Has cognitive impairments or psychotic symptoms

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.