NCT06456307 Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
| NCT ID | NCT06456307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kenyatta National Hospital |
| Condition | Depression, Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,970 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,970 participants in total. It began in 2025-02-17 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
John Kinuthia, MBChB, MMed, MPH
PRINCIPAL INVESTIGATOR
Kenyatta National Hospital
Frequently Asked Questions
Who can join the NCT06456307 clinical trial?
This trial is open to female participants only, aged 14 Years or older, studying Depression, Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06456307 currently recruiting?
Yes, NCT06456307 is actively recruiting participants. Contact the research team at nancym390@gmail.com for enrollment information.
Where is the NCT06456307 trial being conducted?
This trial is being conducted at Nairobi, Kenya, Western Kenya, Kenya.
Who is sponsoring the NCT06456307 clinical trial?
NCT06456307 is sponsored by Kenyatta National Hospital. The principal investigator is John Kinuthia, MBChB, MMed, MPH at Kenyatta National Hospital. The trial plans to enroll 2,970 participants.
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