Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life: Research Protocol for Randomized Controlled Trial in a Resource-Limited Environment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prenatal Depression Symptoms
研究概览
简要总结
The goal of this clinical trial is to learn if a video-guided mindfulness intervention can improve prenatal depression symptoms, improve mental health-related quality of life, reduce the risk of maternal postpartum depression and paternal postpartum depression, and improve neonatal birth outcomes in a resource-constrained setting. This clinical trial will be conducted in pregnant women. The main questions it aims to answer are:
- Can video-guided mindfulness intervention be effective for prenatal depression treatment as compared to routine care?
- Is there a dose-response relationship between the length of a video-guided mindfulness intervention and a reduction in prenatal depression symptoms?
- Does a video-guided mindfulness intervention improve mental health-related quality of life more effectively than routine care?
- What is the impact of intervention duration on the effectiveness of a video-guided mindfulness intervention for improving mental health-related quality of life?
- Can a video-guided mindfulness intervention during pregnancy lead to improved neonatal birth outcomes compared to standard care?
- Can a video-guided mindfulness intervention during pregnancy reduce the risk of developing prenatal depression compared to routine care?
- Can the treatment of maternal prenatal depression through a video-guided mindfulness intervention reduce the risk of paternal postpartum depression? Researchers will compare the intervention group with a group of pregnant women who screen positive for prenatal depression but continue to receive only routine antenatal care, in order to evaluate differences in prenatal depression symptoms, improvements in mental health-related quality of life, reductions in the risk of maternal and paternal postpartum depression, and improvements in neonatal birth outcomes.
Participants (the intervention group) will receive a video-guided mindfulness intervention that they will listen to for eight weeks at their nearest health center three times a week.
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
- Single (Care Provider)
盲法说明
Data collectors Participants in the control arm
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who lived in Jimma City for at least six months
- •Women with a gestational age between 12 and 28 weeks,
- •Women who scored EPDS ≥ 13,
- •Willing to participate for eight consecutive weeks,
- •Able to attend the health center three times per week and gave consent to be followed up by study supervisors and data collectors
排除标准
- •Having been diagnosed with mental health disorders or eating disorders,
- •Active substance use,
- •EPDS item 10 score ≥1 or total EPDS score >19,
- •Currently receiving pharmacological or psychotherapeutic treatment,
- •Regularly practice meditation,
- •Severely ill,
- •Has active pregnancy-related complications that could interfere with attending the mindfulness exercise, or neurological conditions such as epilepsy or seizures
结局指标
主要结局
Prenatal Depression Symptoms
时间窗: The primary outcome will be assessed immediately after the intervention is done; after eight weeks of the initiation of the intervention.
The symptoms of prenatal depression will be measured using the Edinburgh Postnatal Depression Scale. The EPDS is a widely validated 10-item self-report questionnaire designed to screen depressive symptoms primarily in the postnatal period and later extended for prenatal period depression symptoms. The study participants will be asked to report their relevant rating scale out of the available four response options with the EPDS. They will be asked about their experience of the symptoms over the past seven days. The higher score, which is three, indicates greater levels of depressive symptoms, and a zero score shows the absence of the symptoms. The maximum total score in EPDS is 30, where a cut-off score of ≥13 in clinical and research settings is used to indicate positive screened for PND.
次要结局
- Better Mental Health Related Quality of Life(Mental Health Related Quality of Life will be evaluated immediately after intervention (After eight weeks).)
研究者
Bekelu Teka Worku
Principal Investigator
Jimma University