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

Not Applicable
Not yet recruiting
Conditions
Mental Health
Perinatal Depression
Interventions
Combination Product: Mental Fitness Training Camp
Registration Number
NCT06405932
Lead Sponsor
Fangbiao Tao
Brief 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.

Detailed 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 & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
500
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mental Fitness Training CampMental Fitness Training CampThe 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.
Primary Outcome Measures
NameTimeMethod
Edinburgh Postnatal Depression Scale0, 3 weeks, 42 days postpartum

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.

Generalized Anxiety Disorder0, 3 weeks, 42 days postpartum

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.

Secondary Outcome Measures
NameTimeMethod
Maternal and infant endings42 days postpartum

Maternal pregnancy outcomes and general neonatal outcomes were collected via self-administered scales.

World Health Organization Five-item Well-Being Index0, 3 weeks, 42 days postpartum

The scale in question assesses well-being, with higher total scores representing higher levels of well-being.

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