Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Kenyatta National Hospital
2,970 participants
Feb 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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
Interventions
The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to PM+
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06456307