RecruitingNot ApplicableNCT06456307

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

Sponsor

Kenyatta National Hospital

Enrollment

2,970 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Depression, Anxiety Antenatal Depression Postnatal Depression

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.

Eligibility

Sex: FEMALEMin Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a stepped-care approach to treating mood and anxiety disorders during pregnancy, offering different levels of support based on how severe the symptoms are. **You may be eligible if...** - You are at least 28 weeks pregnant - You are attending antenatal (prenatal) care - You are 14 years or older - You screen positive for depression or anxiety symptoms on standard questionnaires - You are willing to return for follow-up visits **You may NOT be eligible if...** - You are less than 28 weeks pregnant - You are at high risk of self-harm - You have cognitive impairments or psychotic symptoms that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntegrated 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

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NCT06456307

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