NCT06405932

Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women

A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,691 (actual)
• Sponsor: Fangbiao Tao · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mental Health
• Perinatal Depression

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mental Fitness Training Camp	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.

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2024-05-09
• Last updated: 2025-12-26

Locations

1 site across 1 country: China