Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,970
- 试验地点
- 3
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Depression
时间窗: 6-months postpartum
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
Anxiety
时间窗: 6-months postpartum
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
次要结局
- Adverse pregnancy outcomes(6-weeks postpartum)
- Quality of life(6-months postpartum)
- Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)(6-weeks postpartum)