Clinical trial NCT04853693: Pregnancy Without Psychosocial Stress
Official title: Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety Disorders and Symptoms
Depression, Postpartum
Lead sponsor: National Institute of Mental Health, Czech Republic
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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 %.

Eligibility criteria: 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)

Primary outcomes:
measure: Treatment gap for postpartum mental disorders
timeFrame: 6 weeks postpartum
measure: Pregnancy depressive symptoms
timeFrame: up to 32 weeks
measure: Postpartum depressive symptoms
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Pregnancy anxiety symptoms
timeFrame: up to 32 weeks
measure: Postpartum anxiety symptoms
timeFrame: 6 weeks postpartum
Other outcomes:
measure: Psychosocial stress factors
timeFrame: through study completion, an average of 1 year
measure: Prenatal mother-baby attachment
timeFrame: up to 32 weeks
measure: Parenting competences
timeFrame: 6 weeks postpartum
Locations:
city: Klecany
country: Czechia
facility: National Institute of Mental Health
Study officials:
affiliation: National Institute of Mental Health, Klecany, Czechia
name: Antonin Sebela, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: