跳至主要内容
临床试验/NCT06770244
NCT06770244Enrolling By Invitation不适用

Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System: Protocol for a Randomized Controlled Trial

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 1,438 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,438
试验地点
1
主要终点
the proportion of participants with postpartum depression

研究概览

简要总结

This study is a prospective, two-arm parallel cluster randomized controlled trial that will compare the intervention effects of a positive psychology-based intervention package with usual care for postpartum depression.

详细描述

Postpartum depression is one of the most common conditions affecting women during the perinatal period. It has a profound negative impact on both women's physical and mental health, manifesting in symptoms such as persistent low mood, sleep disturbances, changes in appetite, and a diminished sense of self-worth. In more severe cases, it may even lead to suicidal ideation or self-harm. Furthermore, postpartum depression significantly impairs a mother's caregiving ability, weakening the emotional bond between mother and infant. This disruption in the mother-infant relationship, in turn, can negatively affect the infant's social, emotional, and cognitive development.

Positive Psychology is an emerging subfield of psychology that focuses on the study of human positive emotions, well-being, and optimal adaptation. In contrast to traditional psychology, which primarily addresses mental illness, abnormal behaviors, and negative emotions, Positive Psychology seeks to explore and enhance the ways in which individuals and groups can thrive in areas such as positive emotions, health, and happiness. By focusing on strengths, resilience, and positive interpersonal relationships, Positive Psychology aims to foster well-being rather than merely alleviating psychological distress.

The emphasis on prevention in Positive Psychology aligns closely with the core principles of community-based primary healthcare, which prioritizes early intervention, education, and the promotion of wellness within a population. By focusing on proactive strategies that enhance mental health, Positive Psychology contributes to a broader public health agenda aimed at reducing the burden of mental disorders through early prevention rather than relying solely on treatment after the onset of illness. Therefore, integrating Positive Psychology into primary healthcare settings-particularly in the prevention and management of postpartum depression in women-offers substantial potential benefits.

This study will design a community-based intervention program for postpartum depression, centered on Positive Psychology, within the framework of the primary healthcare system. The program will be developed based on the developmental characteristics and practical needs of women experiencing postpartum depression. A cluster-randomized controlled trial will be employed to evaluate the effectiveness of the intervention. The findings will provide valuable evidence and support for mental health management measures for pregnant and postpartum women in primary healthcare settings, thereby promoting the effective implementation of maternal and child health initiatives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •age ≥18 years;
  • •women in the early stages of pregnancy;
  • •adequate cognitive, comprehension, and communication abilities, and voluntary participation in the study.

排除标准

  • •individuals with severe organic or somatic diseases;
  • •those with a history of mental illness, substance abuse, or a family history of psychiatric disorders.

研究组 & 干预措施

Intervention group

Experimental

Participants in the intervention group will receive a positive psychology-based primary care intervention package for postpartum depression.

干预措施: positive psychology-based intervention package (Behavioral)

Control group

No Intervention

Participants in the control group will receive usual primary care support.

结局指标

主要结局

the proportion of participants with postpartum depression

时间窗: baseline (early pregnancy, T0), during the intervention (3 months post-randomization, T1; 6 months post-randomization, T2), and after the intervention (1 month postpartum, T3; 3 months postpartum, T4).

次要结局

  • Change in postnatal depression scale score(Baseline up to 3 months postpartum)
  • Anxiety Symptoms Assessment(Baseline up to 3 months postpartum)
  • Stress Assessment(Baseline up to 3 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Gong

Associate Professor of Social Medicne and Health Management Department

Huazhong University of Science and Technology

研究点 (1)

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