Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Recruiting · NCT06456307 · Interventional (participants receive a specific treatment) · Lead sponsor: Kenyatta National Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
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.
Who can take part
Age range
14 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
4 locations listed.
- Kenyatta National Hospital - Nairobi, Kenya
- Kenyatta National Hospital - Nairobi, Kenya
- HomaBay, Siaya and Kisumu - Western Kenya, Kenya
- HomaBay, Siaya and Kisumu - Western Kenya, Kenya