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临床试验/NCT04853693
NCT04853693Unknown不适用

Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children

National Institute of Mental Health, Czech Republic2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Treatment gap for postpartum mental disorders

研究概览

简要总结

The project is aimed at children who are exposed to the toxic psychosocial stress present in their mothers during pregnancy or after childbirth. Due to psychosocial stress in their mothers, these children are at risk of developing a mental disorder or having impaired psychosocial development.

In Czechia, there is no prevention of psychosocial stress in women, which also plays a preventive role in the development of mental disorders in their children. Mental disorders in parents are stigmatized in Czechia, which prevents parents from seeking care.

The investigators want to change this situation, so they will:

  1. create and pilot a screening program for psychosocial stress in perinatal women in gynecological clinics
  2. connect the screening program to the integrated step care system created by the investigators, including peer support, which the investigators will test

详细描述

ACTIVITY 1 Objective of the activity: To increase the support of mental health and well-being of unborn children and children in the period soon after their birth by early detection of women experiencing psychosocial stress during pregnancy and after childbirth. Target group: Pregnant women and postpartum women and their children.

Methods: Because the occurrence of symptoms of psychosocial stress in pregnancy is one of the main predictors of the development of mental disorders after childbirth, the investigators will test whether the introduction of screening in gynecological clinics during pregnancy reduces the incidence of untreated mental disorders in women 6 weeks after birth. Thanks to screening, the investigators want to capture women and their children who are exposed to toxic stress during pregnancy. Screening: Gynecological clinics will be equipped with a tablet with screening software (Czech version of the Edinburgh Perinatal Depression Scale; Perinatal Anxiety Screening Scale; Perinatal Psychosocial Profile). The software runs on the servers of the National Institute of Mental Health (NUDZ), secured against cybercrime. Work with data obtained during screening is subject to GDPR and the process is approved by the NUDZ Ethics Committee. The screening software is automated and sends the woman information about the results to her email.

Evaluation: a randomized controlled study in 20 gynecological clinics in 3 regions of the Czech Republic (Prague, Central Bohemia and Olomouc Region). Participating gynecological outpatient clinics will be randomized in a 1: 1 ratio into two groups: Intervention outpatient clinics: Intervention outpatient clinics offer study participation to all pregnant women during their pregnancy. Furthermore, all women checked at the end of the sixth week. Intervention clinics will also be equipped with information materials on mental health during pregnancy and after childbirth. Control clinics: actively offer participation to all women only at the control at the end of the sixth week postpartum. The main checkpoint in both groups of outpatient clinics is the 6th week after delivery, when the woman comes to the gynecological outpatient clinic for a mandatory check-up in Czechia. All women who will participate in Activity 1 will be examined by telephone using a structured psychiatric examination by a psychiatrist at the end of the 6th week after childbirth so that we can determine the presence of mental disorders.

Hypothesis: There are more women in control clinics who are not treated for a mental disorder at the end of the 6th week after delivery, even if they have been diagnosed, than in intervention clinics.

ACTIVITY 2 Objective of the activity: To increase the support of mental health and well-being of unborn children and children soon after their birth through early intervention in women experiencing psychosocial stress during pregnancy and after childbirth. Target group: Women who experience psychosocial stress during pregnancy and after childbirth and their children. Methods: Activity 2 is directly related to activity 1 of the submitted project. As part of Activity 2, the investigators will provide the women captured by the screening intervention developed by them.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The investigator and person administering the outcome measures are blind to participant group

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ACTIVITY 1:
  • sex-female
  • pregnancy
  • woman is registered during and after pregnancy in one of 20 study gynecological outpatient clinics
  • signing informed consent
  • email address ownership
  • age 18-45
  • Inclusion Criteria ACTIVITY 2:
  • Edinburgh Postpartum Depression Scale score ≥
  • participant identified through the ACTIVITY 1 of the study

排除标准

  • ACTIVITY 1:
  • acute medical illness or significant pregnancy complication (based on self-report)
  • Exclusion Criteria ACTIVITY 2:
  • acute suicidal behavior (based on self-report)

结局指标

主要结局

Treatment gap for postpartum mental disorders

时间窗: 6 weeks postpartum

prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview

Pregnancy depressive symptoms

时间窗: up to 32 weeks

self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.

Postpartum depressive symptoms

时间窗: 6 weeks postpartum

self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.

次要结局

  • Pregnancy anxiety symptoms(up to 32 weeks)
  • Postpartum anxiety symptoms(6 weeks postpartum)

研究者

发起方
National Institute of Mental Health, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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