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Pregnancy Without Psychosocial Stress

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

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

연구 개요

상세 설명

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.

Intervention: Mom supports Mom includes at least four telephone or other contacts - Skype, Zoom, WhatsApp, Facebook Messenger, ...) Between the project participant and a peer consultant trained by the National Institute of Mental Health and Mom´s Smile. Within peer support, the main methods are listening, psychoeducation, basic procedures of cognitive behavioral therapy and mindfulness, shared personal experiences with perinatal psychosocial stress and, if necessary, a reference to professional counseling (psychology, psychiatry).

Evaluation: a randomized controlled study in gynecological clinics participating in Activity 1 of the project. Women experiencing psychosocial stress, which we will screen through Activity 1, will be randomized 1: 1 into two groups: Intervention group: The peer consultant coordinator will connect the woman with the peer consultant who will carry out the intervention Mom supports mom. Control group: The woman will be sent automatic feedback with information on how to proceed if the participant wants to seek help herself. Evaluation of the effect of the intervention: The investigators evaluate depressive symptoms using the Edinburgh scale of perinatal depression; anxiety symptoms using the Perinatal Anxiety Screening Scale; psychosocial stress using the Perinatal Psychosocial Profile; quality of life using the 8-dimensional quality of life scale; and parental competences using the Parenting Sense of Competence Scale. The investigators collect data after the woman enters Activity 2 and one month after entering. The Investigators will evaluate the feedback from users using qualitative questions.

Hypothesis: Intervention Mom supports mom, reduces depressive and anxiety symptoms and general psychosocial stress in women experiencing psychosocial stress. Intervention Mom supports mom, increases the quality of life and parental competencies of women experiencing psychosocial stress.

Statistics: n = 120 (60 in each arm of the study). Sample size is calculated so that the investigators can detect a medium-to-large group difference in the scale of depressive symptoms (effect size = 0.6; t-test) at power 80%, significance level 5% (2-sided) and potential drop out 30 %.

연구 유형

중재적

등록 (예상)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Klecany, 체코, 25067
        • 모병
        • National Institute of Mental Health

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria 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 ≥10.
  • participant identified through the ACTIVITY 1 of the study

Exclusion Criteria ACTIVITY 1:

- acute medical illness or significant pregnancy complication (based on self-report)

Exclusion Criteria ACTIVITY 2:

  • acute suicidal behavior (based on self-report)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mom´s Supporting Mom (MSM)
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
A preventive peer consultation intervention for Postpartum Depression.
다른 이름들:
  • MSM
활성 비교기: Enhanced Treatment as Usual
Referral to treatment in the community and monitoring
Referral to treatment in the community, clinical monitoring
다른 이름들:
  • 에타우

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Postpartum depressive symptoms
기간: 6 weeks postpartum
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
6 weeks postpartum
Treatment gap for postpartum mental disorders
기간: 6 weeks postpartum
prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
6 weeks postpartum
Pregnancy depressive symptoms
기간: up to 32 weeks
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
up to 32 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Postpartum anxiety symptoms
기간: 6 weeks postpartum
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
6 weeks postpartum
Pregnancy anxiety symptoms
기간: up to 32 weeks
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
up to 32 weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Psychosocial stress factors
기간: through study completion, an average of 1 year
self-rated psychosocial stress factors measured by Prenatal psychosocial profile. Score range 11 - 44, higher score represents worse outcome.
through study completion, an average of 1 year
Prenatal mother-baby attachment
기간: up to 32 weeks
self-report measure of maternal-fetal attachment measured by Prenatal Attachment Inventory
up to 32 weeks
Parenting competences
기간: 6 weeks postpartum
self-report measure od maternal sense of parenting competence measured by Parenting Sense of Competence Scale
6 weeks postpartum

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Antonin Sebela, Ph.D., National Institute of Mental Health, Klecany, Czechia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 4월 1일

기본 완료 (예상)

2023년 3월 31일

연구 완료 (예상)

2023년 3월 31일

연구 등록 날짜

최초 제출

2021년 4월 8일

QC 기준을 충족하는 최초 제출

2021년 4월 18일

처음 게시됨 (실제)

2021년 4월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 8일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

De-identified data may be made available to other researchers.

IPD 공유 기간

After the completion of the study

IPD 공유 액세스 기준

Permission of the PI

IPD 공유 지원 정보 유형

  • 정보에 입각한 동의서(ICF)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Mom´s Supporting Mom에 대한 임상 시험

3
구독하다