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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorKenyatta National Hospital

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

2,970 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kenyatta National Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator