Actively Recruiting

Phase Not Applicable
Age: 14Years +
FEMALE
Healthy Volunteers
ID06456307

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending Maternal and Child Health Clinics

Led by Kenyatta National Hospital · Updated on 2025-12-10

2970

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kenyatta National Hospital

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Perinatal mood and anxiety disorders (PMAD), including depression and anxiety during pregnancy or up to one year after childbirth, affect many birthing people worldwide, especially in low- and middle-income countries. These disorders often go undetected and untreated due to limited access to mental health services. This trial aims to evaluate a stepped-care intervention designed to improve screening and treatment of PMAD among perinatal women attending maternal and child health clinics in Kenya, addressing important clinical and implementation outcomes. The study compares two groups: control facilities providing enhanced standard care with basic screening and referral information, and intervention facilities offering the Integrated Perinatal Mental Health Program (IPMH). The IPMH includes systematic screening with PHQ-2 and GAD-2, followed by more detailed assessments for positive cases, weekly counseling sessions called Problem Management Plus (PM+) for women with likely depression or anxiety, and telepsychiatry support for severe symptoms or non-responders. The program aims to integrate these interventions into routine care at clinics in Western Kenya. Participants will be assessed from pregnancy through six months postpartum. Researchers will monitor mental health symptoms using validated screening tools, evaluate quality of life, pregnancy outcomes, and use of coping skills. The study includes regular visits to maternal and child health clinics for screening and treatment sessions. Safety monitoring includes assessing risk of self-harm. The total study duration for each participant covers pregnancy and six months after delivery, with ongoing evaluations to determine the intervention's impact and feasibility in these settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant and at least 28 weeks gestation
  • Attending antenatal care at the facility
  • Female, 14 years old or older
  • Screen positive for perinatal mood and anxiety disorder symptoms using PHQ-2 (score 3 or more) and/or GAD-2 (score 3 or more)
  • Willing to return to the maternal and child health and prevention of mother-to-child transmission clinics for study visits
Not Eligible

You will not qualify if you...

  • Less than 28 weeks gestation
  • High risk of self-harm based on study assessment
  • Cognitive impairments or psychotic symptoms

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Outpatient Treatment

Duration - From enrollment during pregnancy until 6 months postpartum

Participants receive the Integrated Perinatal Mental Health Program (IPMH), including mental health screening, weekly Problem Management Plus counseling for those with depression or anxiety, and telepsychiatry for severe cases or non-responders.

Weekly visits for counseling and assessments during pregnancy and postpartum

Follow-up

Duration - Up to 6 months postpartum after treatment

Participants are monitored for mental health, HIV care, and pregnancy outcomes up to 6 months postpartum after treatment ends.

Visits aligned with postpartum care up to 6 months

Trial Site Locations

Total: 2 locations

1

Kenyatta National Hospital

Nairobi, Kenya

Actively Recruiting

2

HomaBay, Siaya and Kisumu

Western Kenya, Kenya

Actively Recruiting

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Research Team

N

Nancy Ngumbau, MBChB, MPH

A

Agnes Karume, MBChB, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial.

Agnes Karingo Karume, Nancy Ngumbau, Linnet Ongeri...

https://pubmed.ncbi.nlm.nih.gov/42145615