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RECRUITING
NCT06456307
NA

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

Sponsor: Kenyatta National Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2970

Start Date

2025-02-17

Completion Date

2028-03

Last Updated

2025-12-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)

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)

Kenyatta National Hospital

Nairobi, Kenya

HomaBay, Siaya and Kisumu

Western Kenya, Kenya