Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
研究概览
简要总结
This small randomized pilot study will evaluate feasibility and preliminary outcomes of an audio-delivered mindfulness program to reduce psychological distress for mothers with an infant in neonatal intensive care, as compared with an active control condition.
详细描述
An estimated 400,000-480,000 infants in the U.S. with serious medical conditions are cared for in neonatal intensive care units (NICUs) each year. Maternal stress exposure related to infants' NICU stays is an under-appreciated public health problem with negative implications for maternal and child health and wellbeing. Flexible, effective intervention strategies have potential to improve maternal mental health and parenting, promoting positive emotional and behavioral outcomes for both mothers and infants.
In the investigators' successful pilot research, the investigators developed an audio-delivered mindfulness program to help NICU mothers reduce rumination and worry, cultivate a state of calm awareness, and promote self care. In this small randomized pilot study, the investigators will randomly assign mothers with an infant in the neonatal intensive care unit (NICU) to receive either the mindfulness intervention or an active control program (audio-delivered education on infant care and development).
This study will evaluate feasibility of all key research aspects, including recruitment, randomization, intervention and control conditions, and assessments, in preparation for a future larger-scale study. This study will also assess preliminary intervention outcomes to identify potential program benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years old
- •mother of an infant currently being treated in the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center NICU
- •able to speak English
排除标准
- •known to have serious psychopathology
- •infant medically unstable/ progress is poor
结局指标
主要结局
Depressive symptoms as assessed by the Patient Health Questionnaire (PHQ)-8
时间窗: 2 weeks
Self-reported depressive symptoms over the last 2 weeks. Each of the 8 items is scored 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 24. Higher scores mean more depressive symptoms.
Anxiety symptoms as assessed by the Generalized Anxiety Disorder - 7 (GAD-7)
时间窗: 2 weeks
Self-reported anxiety symptoms over the last 2 weeks. Each of the 7 items is rated from 0 (not at all) to 3 (nearly every day), yielding a total between 0 and 21. Higher scores mean more anxiety.
次要结局
- Perceived stress as assessed by the Perceived Stress Scale - NICU (PSS-NICU)(Up to 2 weeks)
- Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(4 weeks)
- Trauma symptoms as assessed by the Stanford Acute Stress Reaction Questionnaire (SASRQ)(2 weeks)
- Coping as assessed by the Brief Cope Scale(Up to 2 weeks)