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
研究组 & 干预措施
Intervention arm
The intervention arm will receive a video-guided mindfulness practice consisting of audio recordings (in two local languages: Afan Oromo and Amharic) combined with familiar natural environment visuals. The exercise instruction consists of three core mindfulness practices: (i) Focus the Mind: to cultivate present-moment attention and reduce cognitive rumination; (ii) Breath Awareness: to anchor attention and promote relaxation; and (iii) Basic Body Scan: to encourage non-judgmental awareness of bodily sensations to enhance their mind-body connection.
The intervention will be delivered face-to-face at the health centers using a smartphone-based video. The intervention is planned to be delivered regularly according to a standardized schedule for each of the women individually. Each session of the exercise can last for about 21-23 minutes. Hired Midwifery Nurses at each of the health centers will support the woman to start the exercise and follow her till the end of the sessions daily.
干预措施: Video-guided Mindfulness Exercise (Other)
Control group
The control group will continue with the routine maternal and other standard health care services as provided by the health centers in accordance with national maternal health guidelines. In Ethiopia, according to the National Antenatal Care Guideline 2022, each woman must visit the health facility for eight contacts. They are expected to screened for potentially recurring obstetric complications such as recurrent pregnancy loss, preterm labor, pre-eclampsia/eclampsia, gestational diabetes, congenital anomaly, puerperal psychosis, obstetric and gynecologic surgery, immunologic disorders, medical and mental health disorders, infectious diseases, physical disability and developmental disorders, nutritional history, social and personal history, current medication, and intimate partner violence. They receive counselling on the risk of pregnancy, contraception, micronutrient supplementation, weight gain monitoring, counselling on the increased risk to the fetus, and other related services.
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