Prevention of Perinatal Depression Among At-risk Individuals Through Integration of a Multimedia, Web-based Intervention Within the Healthcare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Implementation outcome; Feasibility and acceptability
研究概览
简要总结
This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory.
Using the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio
详细描述
This type1 hybrid effectiveness-implementation project is conducted within healthcare settings and underserved populations (rural, urban, and Latino) and for individuals who are at risk for perinatal depression (PD), which allows the team to refine the approach in preparation for a future effectiveness trial for the prevention of PD in diverse communities using accessible Digital Mental Health Technology (patient education portal, FB discussion boards, synchronous videoconference support sessions). The plan is to adopt a randomized preference trial design to assess the impact of patient preference and sociocultural factors (including race, ethnicity, and geographic residence) on engagement and preliminary results. This information is crucial for a subsequent trial and for ultimately taking the intervention to scale. The study design using the IRLM reflects scientific rigor that can be reproduced by other investigators. The implemented strategies specifically developed to optimize implementation success, and to measure the implementation outcomes of these strategies and include valuable input from key informants, stakeholders, and the Community Advisory Board at regular intervals throughout the project time period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •18+ years of age, who at the time of screening
- •Have a viable pregnancy or are postpartum (up to 1 year)
- •Identified as at-risk for PD (any one of the following:
- •EPDS score equal to or greater than 9 or less than 21
- •History of depression/anxiety
- •2 or more significant life events)
- •English- or Spanish-speaking
- •Currently attending a UHealth clinic or rural public health partner clinic.
排除标准
- •Have a substance use disorder
- •Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS > 20)
- •Severe anxiety, suicidality, or currently taking any medications for a mental health condition.
结局指标
主要结局
Implementation outcome; Feasibility and acceptability
时间窗: (6, 12 & 18 months)
EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Using scores that are between 9-20 Qualitative; semi structured interview Quantitative; patient satisfaction survey, number of referrals for at-risk patients, patients registering on YoMingo. focus groups, individual interviews, questionnaires
次要结局
- Sociocultural Determinants and Behavior(6, 12 & 18 months))
研究者
Gwen Latendresse
Professor
University of Utah