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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405932
• Other study ID #: 202451
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: March 10, 2026

Study information

• Verified date: May 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 May 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. Pregnant women in the intervention group attended a three-week "mental fitness training camp" and were followed up at three different points in time. The control group received routine care.

Description:

The self-help mental fitness training camp, comprising 21 learning modules structured around animated thinking videos, audio, text, and moving images, primarily incorporates the fundamental principles of cognitive behavioral therapy and mindfulness, with the aid of the Internet WeChat platform. Participants were evaluated on four occasions following their enrollment: at baseline, immediately following the intervention, 5-8 weeks after randomization, and 42 days after delivery. The present study focused on the generalised intervention and preventive effects of the Mental Fitness Training Camp on negative emotions in perinatal women.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 10, 2026
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women

• The gestational week in early pregnancy is 10 to 14 weeks; the gestational week in mid-pregnancy is 20 to 24 weeks; and the gestational week in late pregnancy is 28 to 32 weeks.

• No psychological intervention in the last 6 months.

• 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.

Related Conditions & MeSH terms

• Depression
• Mental Health
• Perinatal Depression

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fangbiao Tao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 5 to 8 weeks, 42 days postpartum
Primary	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, 5 to 8 weeks, 42 days postpartum
Secondary	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, 5 to 8 weeks, 42 days postpartum
Secondary	Freiburg Mindfulness Inventory	The level of mindfulness in the daily lives of the study participants was assessed by calculating the total score. A higher total score indicates a higher level of mindfulness.	0, 3 weeks, 5 to 8 weeks, 42 days postpartum
Secondary	Perceived Stress Scale	The perceived stress load of the study participants in the past month is assessed by a scale comprising four entries, which are scored on a scale of 0 to 4. A higher total score indicates a higher level of perceived stress in the individual.	0, 3 weeks, 5 to 8 weeks, 42 days postpartum