Anhui Medical University
Hefei, Anhui, 230022, China
NCT Number: NCT06405932
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Hefei, Anhui, 230022, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Mental Fitness Training camp employs and incorporates core learning content derived from Cognitive Behavioral Therapy and Mindfulness. The program comprises nine thought animations, emotional diary, daily breathing exercises, and pleasure lists.
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.
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.
Time frame: 42 days postpartum
Maternal pregnancy outcomes and general neonatal outcomes were collected via self-administered scales.
Time frame: 0, 3 weeks, 42 days postpartum
The scale in question assesses well-being, with higher total scores representing higher levels of well-being.
Fangbiao Tao
Other
A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy
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