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

Fangbiao Tao

Status: Completed

Conditions: Perinatal Depression; Mental Health

Treatments: Combination Product: Mental Fitness Training Camp

Study type: Interventional

Funder types: Other

Identifiers

NCT06405932

202451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,691 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,691 participants in 2 patient groups

Mental Fitness Training Camp

Experimental group

Description:

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.

Treatment:

Combination Product: Mental Fitness Training Camp

health education

No Intervention group

Description:

The control group received routine-care