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

NCT06405932 | Completed

• 1 other identifier: 202451
• Study Type: interventional
• Target: 1,691
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Perinatal Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Maternal and infant endings

  42 days postpartum

• World Health Organization Five-item Well-Being Index

  0, 3 weeks, 42 days postpartum

Study Arms (2)

Mental Fitness Training Camp

EXPERIMENTAL

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

health education

NO INTERVENTION

The control group received routine-care

Interventions

Mental Fitness Training Camp 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.

Mental Fitness Training Camp

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suffering from depression being treated with psychotherapy or medication.
• The presence of a serious mental illness or intellectual disability.

Sponsors & Collaborators

• Fangbiao Tao: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Chengli Tang

  Anhui Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 9, 2024
• Study Start: September 11, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CN (1)