Clinical trial NCT06456307: Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Official title: Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Kenyatta National Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-13
Enrollment: 2970
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Depression
timeFrame: 6-months postpartum
measure: Anxiety
timeFrame: 6-months postpartum
Secondary outcomes:
measure: Quality of life
timeFrame: 6-months postpartum
measure: Adverse pregnancy outcomes
timeFrame: 6-weeks postpartum
measure: Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)
timeFrame: 6-weeks postpartum
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
city: Western Kenya
country: Kenya
facility: HomaBay, Siaya and Kisumu
Study officials:
affiliation: Kenyatta National Hospital
name: John Kinuthia, MBChB, MMed, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Keshet Ronen, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Amritha Bhat, MBBS, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: