The Pregnancy and Postpartum Mental Health Optimization Virtual Intervention Network (MOVIN): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 2
- 主要终点
- Depressive symptoms
研究概览
简要总结
Depression, anxiety, and related disorders such as post-traumatic stress and obsessive compulsive disorder affect about 20% of pregnant and postpartum people. When not treated properly, these issues negatively impact not only affected people, but also their children's health and development. Only 1 in 5 receive adequate treatment, so identifying new system-wide approaches to reliably deliver recommended care to perinatal mental health patients all is a crucial health care priority. The Pregnancy and Postpartum Mental health Optimization Virtual Intervention Network (MOVIN) is a scalable perinatal mental health platform building on the evidence-based Collaborative care delivery model. MOVIN's online platform allows patients to connect with a care coordinator to co-develop personalized treatment recommendations, in collaboration with their primary care clinician and a perinatal psychiatrist when needed; progress is tracked to re-evaluate.
详细描述
The Pregnant and Postpartum Mental Health Optimization Virtual Intervention Network (MOVIN) is a model of stepped, collaborative care delivered virtually, accessible to pregnant and postpartum individuals across Ontario based at Women's College Hospital. Access to MOVIN includes access to a web platform with curated educational material and treatment resources, personalized treatment planning between a participant and the MOVIN Care Coordinator (informed by systematic measurement-based follow-up of mental health symptoms), liaison between the MOVIN Care Coordinator and the participant's primary care clinician, and direct referral to a perinatal psychiatrist if required. Participants will be allocated 1:1 (intervention: control) using a computer-generated random allocation sequence in randomly varying block sizes. The primary outcome will be depressive symptoms (considered as a continuous variable) at 24-weeks post-randomization, measured using the patient-reported Edinburgh Postnatal Depression Scale (EPDS). The main secondary outcome is symptom remission (EPDS <10) at 24-weeks post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18 years or older)
- •Pregnant or postpartum and living with their infant 0-6 months old. This includes all individuals who identify as women, as well as those of female sex who do not identify as women (e.g., non-binary, trans) who are the primary parent for their infant. This includes via natural birth, adoption, or surrogacy.
- •EPDS score >10 at eligibility screening.
排除标准
- •Active alcohol or substance use disorder, mania or psychotic disorder (as these conditions are better managed in direct specialty care).
- •Active suicide plan or intent (as emergent hospital-based care is likely required),
- •Plan to move out of Ontario during the study.
- •Unable to complete relevant study procedures and measures online. For the few participants without access to devices/home internet, we will budget for tablets/data plans.
- •Unable to complete study activities in English. Note that Google translate is available for the intervention platform and language lines are available for participants so that they can be served in their language of choice, however we are unable to provide translations of all study assessment and questionnaire materials that participants will need to complete during the study.
- •No primary care clinician (required for collaborative mental health care delivery model).
- •Currently enrolled in a collaborative mental health care model.
研究组 & 干预措施
Enhanced Usual Care
Access to online resources and educational materials about general mental health, maternal mental health, depression and anxiety in the pregnancy and postpartum period, and an up-to-date listing of treatment services available in Ontario. These resources are maintained by the MOVIN study team.
干预措施: Enhanced Usual Care (Other)
MOVIN
Enhanced Usual Care plus MOVIN Care Platform. The MOVIN Care Platform is virtual collaborative care intervention with a stepped care approach in which a care coordinator directs participants to one or more evidence-based virtual interventions as appropriate.
干预措施: MOVIN Care Platform (Other)
MOVIN
Enhanced Usual Care plus MOVIN Care Platform. The MOVIN Care Platform is virtual collaborative care intervention with a stepped care approach in which a care coordinator directs participants to one or more evidence-based virtual interventions as appropriate.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Depressive symptoms
时间窗: 24 weeks post randomization
The primary objective of this trial is to determine the effect of MOVIN versus a control condition on perinatal depression symptoms. Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30.
次要结局
- Maternal Remission of depression(24 weeks post randomization)
- Maternal Depressive symptoms(12 and 24 weeks post randomization)
- Maternal Posttraumatic Stress Disorder Checklist(12 and 24 weeks post randomization)
- Maternal anxiety symptoms(12 and 24 weeks post randomization)
- Maternal quality of life symptoms(12 and 24 weeks post randomization)
- Health service use: participant time(12 and 24 weeks post randomization)
- Health service use: participant cost(12 and 24 weeks post randomization)
- Health service use: health system costs(12 and 24 weeks post randomization)
- Maternal child relationship(If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum)
- Health service use: participant time(12 and 24 weeks post randomization)
- Maternal Remission of depression(24 weeks post randomization)
- Maternal Depressive symptoms(12 and 24 weeks post randomization)
- Obsessive-Compulsive Inventory-Revised(12 and 24 weeks post randomization)
- Maternal Posttraumatic Stress Disorder Checklist(12 and 24 weeks post randomization)
- Maternal anxiety symptoms(12 and 24 weeks post randomization)
- Maternal quality of life symptoms(12 and 24 weeks post randomization)
- Health service use: participant cost(12 and 24 weeks post randomization)
- Maternal child relationship(If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum)
- Health service use: health system costs(12 and 24 weeks post randomization)
- Dyadic relationship(12 and 24 weeks post randomization)
- Child Development(If postpartum at enrollment: Baseline + 1y postpartum. If pregnant at enrollment: 1y postpartum.)
- Maternal Depressive symptoms(12 weeks post randomization)