MedTrace Logo

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

NCT06456307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2970

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Depression, Anxiety
  • Antenatal Depression
  • Postnatal Depression

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+

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Kenyatta National Hospital

    lead OTHER_GOV

Principal Investigators

  • John Kinuthia, MBChB, MMed, MPH · Kenyatta National Hospital

  • Keshet Ronen, MPH, PhD · University of Washington

  • Amritha Bhat, MBBS, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456307 on ClinicalTrials.gov