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

NCT ID: NCT06405932

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1691 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2025-10-01

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.

Conditions

Mental Health; Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mental Fitness Training Camp

Intervention Type: COMBINATION_PRODUCT

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.

health education

The control group received routine-care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fangbiao Tao

OTHER

Sponsor Role: lead

Responsible Party

Fangbiao Tao

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chengli Tang

Role: STUDY_DIRECTOR

Anhui Medical University

Locations

Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

202451

Identifier Type: -

Identifier Source: org_study_id