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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 14
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
Kenyatta National Hospital
RECRUITING
Nairobi
HomaBay, Siaya and Kisumu
RECRUITING
Western Kenya
Contact Information
Primary
Nancy Ngumbau, MBChB, MPH
nancym390@gmail.com
+254713917226
Backup
Agnes Karume, MBChB, MPH
karumeagnes@gmail.com
+254715181283
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2028-03
Participants
Target number of participants: 2970
Treatments
No_intervention: Control arm: Enhanced Standard of care
Control facilities will provide enhanced standard of care. The enhanced standard of care will include two enhancements:~1. HIV Testing Services (HTS) providers and lay workers will conduct screening for perinatal mood and anxiety disorders (PMAD) using the PHQ-2 and GAD-2.~2. The study team will provide a PMAD referral information sheet to all control facilities describing inpatient and outpatient psychiatry services at the nearby referral hospitals
Experimental: Intervention arm: Integrated Perinatal Mental Health Program (IPMH)
Intervention facilities will receive the Integrated Perinatal Mental Health Program (IPMH). This includes:~1. Systematic screening for PMAD symptoms using PHQ-2 and GAD-2. Positive screeners (PHQ-2≥3 and/or GAD-2≥3) will then be referred to nurses to administer additional screening by PHQ-9 and GAD-7~2. Non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) delivered weekly~3. 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 Problem Management+
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Kenyatta National Hospital

This content was sourced from clinicaltrials.gov

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