跳至主要内容
临床试验/NCT07329270
NCT07329270已完成不适用

Postpartum Depression Prevention Program in Disaster-Affected Regions

Istanbul Bilgi University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Postpartum Depressive Symptoms

研究概览

简要总结

Postpartum depression is a common mental health problem that can affect women after childbirth and may have long-lasting consequences for both mothers and infants. The risk of postpartum depression is substantially higher in disaster-affected regions due to exposure to trauma, loss, displacement, disruption of health services, and ongoing psychosocial stressors.

This study aimed to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye using a sequential mixed-methods design. In the first phase, the program was developed based on qualitative findings obtained through in-depth interviews with postpartum women. In the second phase, the effectiveness of the newly developed program was tested using an experimental design.

During the qualitative phase, in-depth interviews were conducted with 24 postpartum women, and data were analyzed using interpretative phenomenological analysis (IPA) to explore women's lived experiences, perceived needs, and priorities related to mental health and psychosocial support after childbirth in a disaster context. The findings from this phase informed the content, structure, and delivery of the trauma-informed prevention program.

In the quantitative phase, the program was evaluated through a randomized controlled trial. Eligible postpartum women were randomly assigned either to the trauma-informed prevention program or to a comparison group receiving usual primary health care services. Postpartum depressive symptoms were assessed using validated measures.

The primary objective of the study was to evaluate the effectiveness of the trauma-informed program in reducing postpartum depressive symptoms. The findings are expected to contribute to evidence-based, trauma-informed approaches for preventing postpartum depression in disaster-affected settings.

详细描述

Women living in disaster-affected regions face increased vulnerability to postpartum depression due to exposure to traumatic events, loss of social and material resources, disruptions in health care delivery, and prolonged uncertainty. Addressing postpartum mental health in such contexts requires interventions that are both evidence-based and responsive to women's lived experiences.

This study employed a sequential mixed-methods design to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye. The study consisted of two consecutive phases: a qualitative program development phase and a quantitative experimental evaluation phase.

In the first phase, the trauma-informed postpartum depression prevention program was developed by the research team based on qualitative data collected from 24 postpartum women. In-depth, semi-structured interviews were conducted to explore participants' lived experiences of the postpartum period in a disaster context, perceived psychosocial needs, sources of distress and support, and expectations from health care services. The qualitative data were analyzed using interpretative phenomenological analysis (IPA), allowing for an in-depth understanding of participants' subjective experiences and meaning-making processes. The findings from this phase directly informed the content, focus, and delivery strategies of the intervention.

In the second phase, the effectiveness of the newly developed program was evaluated using an experimental design. Eligible postpartum women were recruited through primary health care services and randomly assigned to either the intervention group, which received the trauma-informed postpartum depression prevention program, or a comparison group receiving usual postpartum care. The intervention was delivered within routine primary health care settings by trained health care professionals.

The primary outcome of the study was postpartum depressive symptoms, assessed using validated screening instruments at predefined follow-up points. Secondary outcomes included measures of perceived social support, stress and coping perception. Data collection and outcome assessments were conducted in accordance with the study protocol.

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 (Participant)

盲法说明

Participants were masked to group assignment. Due to the nature of the psychosocial intervention, care providers were not masked.

入排标准

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

入选标准

  • Postpartum women aged 18 years or older
  • Having an infant younger than 60 days at the time of enrollment
  • Living in earthquake-affected regions of Türkiye
  • Receiving routine postpartum follow-up through primary health care services
  • Able to communicate in Turkish
  • Provided written informed consent

排除标准

  • History of a diagnosed psychiatric disorder prior to the current postpartum period
  • Severe medical conditions requiring specialized care
  • Cognitive impairment or any con

研究组 & 干预措施

Trauma-Informed Postpartum Depression Prevention Program

Experimental

Participants in this arm received a trauma-informed postpartum depression prevention program developed by the research team. The program was informed by findings from an initial qualitative phase using interpretative phenomenological analysis and was integrated into routine primary health care services in earthquake-affected regions. The intervention focused on early identification of psychological distress, psychoeducation, emotional support, strengthening coping skills, and enhancing social support.

干预措施: Trauma-Informed Preventive Intervention (Behavioral)

No Intervention / Usual Care

No Intervention

Participants in this arm received usual postpartum care provided through routine primary health care services without a structured trauma-informed mental health prevention component.

结局指标

主要结局

Postpartum Depressive Symptoms

时间窗: Baseline and at infant age 6 months.

Postpartum depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item self-report instrument widely used for screening depressive symptoms during the postpartum period. Higher scores indicate greater severity of depressive symptoms. The primary outcome was the change in EPDS scores from baseline to six months post-intervention.

次要结局

  • Perceived Stress(Baseline and at infant age 6 months.)

研究者

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

Zeynep Şimşek

Professor of Public Health and Social Work / Dean, Faculty of Health Sciences

Istanbul Bilgi University

研究点 (1)

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