Actively Recruiting

Phase Not Applicable
Age: 14Years +
FEMALE
Healthy Volunteers
NCT06456307

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

Led by Kenyatta National Hospital · Updated on 2025-12-10

2970

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

Sponsors

K

Kenyatta National Hospital

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 14Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant and at least 28 weeks gestation
  • Attending antenatal care at the facility
  • 14 years old or older
  • Screen positive for perinatal mood and anxiety disorder symptoms (PHQ-2 score 3 or more and/or GAD-2 score 3 or more)
  • Willing to return to the maternal and child health and PMTCT clinic for study visits
Not Eligible

You will not qualify if you...

  • Less than 28 weeks gestation
  • High risk of self-harm based on study assessment
  • Cognitive impairments or psychotic symptoms

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Kenyatta National Hospital

Nairobi, Kenya

Actively Recruiting

2

HomaBay, Siaya and Kisumu

Western Kenya, Kenya

Actively Recruiting

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Research Team

N

Nancy Ngumbau, MBChB, MPH

CONTACT

A

Agnes Karume, MBChB, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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