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

NCT06456307 | Recruiting DMC

• 3 other identifiers: P425/04/2023STUDY00017933R01MH133266
• Study Type: interventional
• Target: 2,970
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Anxiety; Antenatal Depression; Postnatal Depression

Keywords

perinatal mood and anxiety disorders; telepsychiatry; Problem management plus; Integrated Perinatal Mental Health; Pregnancy; Postpartum; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Depression

  Patient Health Questionnaire-9 (PHQ-9). Score range 0-27. Higher score indicates more severe depression symptoms; score ≥10 indicates symptoms of moderate-to-severe depression

  6-months postpartum

• Anxiety

  Generalised Anxiety Disorder-7 item (GAD-7). Score range 0-21. Higher score indicates more severe anxiety symptoms; score ≥10 indicates symptoms of moderate-to-severe anxiety

  6-months postpartum

Secondary Outcomes (3)

• Quality of life

  6-months postpartum

• Adverse pregnancy outcomes

  6-weeks postpartum

• Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)

  6-weeks postpartum

Study Arms (2)

Control arm: Enhanced Standard of care

NO INTERVENTION

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

Intervention arm: Integrated Perinatal Mental Health Program (IPMH)

EXPERIMENTAL

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+

Behavioral: Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)

Interventions

Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry) BEHAVIORAL

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+

Intervention arm: Integrated Perinatal Mental Health Program (IPMH)

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenyatta National Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Kenyatta National Hospital

Nairobi, Kenya

RECRUITING

HomaBay, Siaya and Kisumu

Western Kenya, Kenya

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Officials

• John Kinuthia, MBChB, MMed, MPH

  Kenyatta National Hospital

  PRINCIPAL INVESTIGATOR

• Keshet Ronen, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Amritha Bhat, MBBS, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Ngumbau, MBChB, MPH

CONTACT

+254713917226; nancym390@gmail.com

Agnes Karume, MBChB, MPH

CONTACT

+254715181283; karumeagnes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A 1:1 cluster-randomized trial will be conducted in 20 facilities in Western Kenya among pregnant women (3rd trimester) with perinatal mood and anxiety (PMAD) symptoms (Patient Health Questionnaire-2 \[PHQ-2\]≥3 or Generalized Anxiety Disorder-7 \[GAD-7\]≥3). Control facilities will provide enhanced standard of care (PMAD screening followed by standard of care). Intervention facilities will provide IPMH. Effectiveness outcomes will be compared between study arms.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At the end of the project.
• Access Criteria: The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.

Locations

KE (2)