A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fangbiao Tao
- Enrollment
- 1691
- Primary Endpoint
- Edinburgh Postnatal Depression Scale
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Fangbiao Tao
Professor
Anhui Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Suffering from depression being treated with psychotherapy or medication.
- •The presence of a serious mental illness or intellectual disability.
Outcomes
Primary Outcomes
Edinburgh Postnatal Depression Scale
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Maternal and infant endings(42 days postpartum)
- World Health Organization Five-item Well-Being Index(0, 3 weeks, 42 days postpartum)