An interventional study of Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry) in Depression, Anxiety, Antenatal Depression and Postnatal Depression, sponsored by Kenyatta National Hospital. Recruiting at 2 sites in Kenya. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Kenyatta National Hospital · Not applicable, Interventional, and Treatment
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.
Globally, perinatal mood and anxiety disorders (PMAD) impacts 10-20% of perinatal women, with a pooled prevalence of depression at 11.9% and anxiety at 15.2%. Most of these cases go undetected and untreated since worldwide under 30% of those requiring mental health services have access to them. The Kenya Mental Health Action Plan 2021-2025 highlights a goal of expanding access to mental health services including in Maternal and Child Health clinics. In Kenya, over 95% of all pregnant women receive at least one antenatal care service from a skilled provider. However, mental health screening is not currently standardized in antenatal and postnatal care visits in Kenya, representing a missed opportunity to offer mental health services to those with PMAD symptoms.
Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings. However, their implementation in routine care in Kenya is currently limited, due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers (such as primary care providers and mental health providers). Sustainable integration of perinatal mental healthcare in Kenya's routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres, as well as implementation strategies to facilitate high-quality intervention delivery. The investigators have identified three EBIs to promote perinatal mental health: universal WHO Mental Health Gap Action Programme (mhGAP)-recommended mental health screening, the Problem Management Plus (PM+) counseling intervention for women experiencing PMAD, and telepsychiatry for women with severe symptoms, suicidality or no response to PM+. The investigators propose to combine these interventions in a stepped care model, named the Integrated Perinatal Mental Health program (IPMH), and develop implementation strategies to support the model's integration into routine perinatal care in Kenya. The investigators will then evaluate IPMH's effectiveness and implementation outcomes in a Hybrid Type II trial. The study will be conducted in clinics in Kisumu, Siaya, and Homa Bay counties of Western Kenya, Kenya.
Broad objective: This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program (IPMH) that consists of universal mental health screening, problem management plus counseling intervention and telepsychiatry in a Hybrid Type II trial.
Aim 1: Using participatory design, optimize and adapt IPMH and develop implementation strategies.
Aim 2: Determine the effect of IPMH and implementation strategies on mental health, HIV care, and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum.
Aim 3: Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes, and identify multilevel drivers of successful implementation.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 2,970 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
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 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)
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+
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
Time frame: 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
Time frame: 6-months postpartum
Quality of life
World Health Organisation Quality-of-Life Brief Version (WHOQOL-BREF) score. Score range 0 - 100. Higher scores indicate higher quality of life.
Time frame: 6-months postpartum
Adverse pregnancy outcomes
Any adverse pregnancy outcomes defined as the following: Pregnancy loss, stillbirth, pre-term birth, low birth weight, intrauterine growth restriction, neonatal hospital admission and neonatal death
Time frame: 6-weeks postpartum
Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)
Reducing Tension Checklist. Score range 0 - 40. Higher score indicates more use of behavioral and psychosocial coping skills.
Time frame: 6-weeks postpartum
Plan to share: Yes — Data from IPMH will be available through the NMIH Data Archive
Supporting information: Study protocol, Sap, Icf, Analytic code
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Kenyatta National Hospital