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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health; Perinatal Depression
• Intervention / Treatment: Combination product: Mental Fitness Training Camp

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.

• Study Type: Interventional
• Enrollment (Actual): 1691
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: health education; The control group received routine-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	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.	0, 3 weeks, 42 days postpartum
Generalized Anxiety Disorder	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.	0, 3 weeks, 42 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal and infant endings	Maternal pregnancy outcomes and general neonatal outcomes were collected via self-administered scales.	42 days postpartum
World Health Organization Five-item Well-Being Index	The scale in question assesses well-being, with higher total scores representing higher levels of well-being.	0, 3 weeks, 42 days postpartum

Collaborators and Investigators

• Sponsor: Fangbiao Tao
• Investigators: Study Director: Chengli Tang, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 202451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No