Clinical trial NCT06405932: Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal Women
Official title: A Multi-center Randomized Controlled Trial : Study of the Intervention Effect of "a Self-help Mental Fitness Training Camp"on Depression Symptoms During Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Perinatal Depression
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 0, 3 weeks, 42 days postpartum
measure: Generalized Anxiety Disorder
timeFrame: 0, 3 weeks, 42 days postpartum
Secondary outcomes:
measure: Maternal and infant endings
timeFrame: 42 days postpartum
measure: World Health Organization Five-item Well-Being Index
timeFrame: 0, 3 weeks, 42 days postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Anhui Medical University
name: Chengli Tang
role: STUDY_DIRECTOR
References: