A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,691
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale
研究概览
简要总结
This study was a multi-center randomized controlled trial of an Internet-based self-help mental fitness training camp intervention that included women in early, mid, and late pregnancy with or without psychological distress. A comparison was conducted between the intervention and control groups with regard to depression and anxiety scores during pregnancy and at 42 days postpartum in order to ascertain the efficacy of a self-help mental fitness training camp in preventing negative emotions among perinatal women. In addition, associations between different modes of intervention and maternal and infant outcomes were investigated.
详细描述
In this study, the principle of "early detection, early diagnosis and early treatment" was used to screen and manage negative emotions such as anxiety and depression in three time windows: early pregnancy, mid-pregnancy and late pregnancy. All weeks from June to December 2024 were randomly divided into intervention and control weeks. Pregnant women were assigned to the intervention or control group according to the week of their visit to the hospital for obstetric examination. The intervention group of pregnant women participated in a three-week program of mental fitness training, while the control group received standard care.
The participants were evaluated on multiple occasions following their enrollment in the study. These evaluations occurred at the baseline stage, immediately following the intervention, during the mid and late stages of pregnancy, and 42 days after delivery.
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
- Single (Outcomes Assessor)
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
- •Pregnant women
- •The gestational week in early pregnancy is 0 to 13 weeks; the gestational week in mid-pregnancy is 14 to 27 weeks; and the gestational week in late pregnancy is 28 to 32 weeks.
- •Intention to have children in this pregnancy.
- •Ability to understand and complete the questionnaire independently.
- •Informed consent and voluntary participation in this study.
排除标准
- •Suffering from depression being treated with psychotherapy or medication.
- •The presence of a serious mental illness or intellectual disability.
研究组 & 干预措施
Mental Fitness Training Camp
The self-help mental fitness training camp, comprising 21 learning modules structured around animated thinking videos, audio, text, and moving images, lasts 21 days. Each learning module is automatically pushed to the intervention group on a daily basis, with an estimated completion time of 30-50 minutes.
干预措施: Mental Fitness Training Camp (Combination Product)
health education
The control group received routine-care
结局指标
主要结局
Edinburgh Postnatal Depression Scale
时间窗: 0, 3 weeks, 42 days postpartum
The scale is employed to assess the severity of depression and comprises 10 items, each of which is scored on a 0 to 3 point scale. A total score of 0 to 9 indicates a negative result, 10 to 12 indicates mild depression, 13 to 16 indicates moderate depression, and a score greater than or equal to 17 indicates severe depression.
Generalized Anxiety Disorder
时间窗: 0, 3 weeks, 42 days postpartum
The scale is designed to assess the severity of an individual\'s anxiety symptoms over the past two weeks. It comprises seven entries, each rated on a scale of 0 to 3. A total score of 5 to 9 is indicative of mild anxiety, 10 to 14 of moderate anxiety, and a score of 15 or above of severe anxiety.
Edinburgh Postnatal Depression Scale
时间窗: 0, 3 weeks, 42 days postpartum
The scale is employed to assess the severity of depression and comprises 10 items, each of which is scored on a 0 to 3 point scale. A total score of 0 to 9 indicates a negative result, 10 to 12 indicates mild depression, 13 to 16 indicates moderate depression, and a score greater than or equal to 17 indicates severe depression.
Generalized Anxiety Disorder
时间窗: 0, 3 weeks, 42 days postpartum
The scale is designed to assess the severity of an individual\'s anxiety symptoms over the past two weeks. It comprises seven entries, each rated on a scale of 0 to 3. A total score of 5 to 9 is indicative of mild anxiety, 10 to 14 of moderate anxiety, and a score of 15 or above of severe anxiety.
次要结局
- Maternal and infant endings(42 days postpartum)
- World Health Organization Five-item Well-Being Index(0, 3 weeks, 42 days postpartum)
- Maternal and infant endings(42 days postpartum)
- World Health Organization Five-item Well-Being Index(0, 3 weeks, 42 days postpartum)
研究者
Fangbiao Tao
Professor
Anhui Medical University