Pregnancy Without Psychosocial Stress
Primary Purpose
Depressive Symptoms, Anxiety Disorders and Symptoms, Depression, Postpartum
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Mom´s Supporting Mom
Enhanced Treatment As Usual
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms
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)
Sites / Locations
- National Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mom´s Supporting Mom (MSM)
Enhanced Treatment as Usual
Arm Description
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Referral to treatment in the community and monitoring
Outcomes
Primary Outcome Measures
Treatment gap for postpartum mental disorders
prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
Pregnancy depressive symptoms
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Postpartum depressive symptoms
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Secondary Outcome Measures
Pregnancy anxiety symptoms
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Postpartum anxiety symptoms
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Full Information
NCT ID
NCT04853693
First Posted
April 8, 2021
Last Updated
April 8, 2022
Sponsor
National Institute of Mental Health, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04853693
Brief Title
Pregnancy Without Psychosocial Stress
Official Title
Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
create and pilot a screening program for psychosocial stress in perinatal women in gynecological clinics
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 %.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety Disorders and Symptoms, Depression, Postpartum
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and person administering the outcome measures are blind to participant group
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mom´s Supporting Mom (MSM)
Arm Type
Experimental
Arm Description
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
Referral to treatment in the community and monitoring
Intervention Type
Behavioral
Intervention Name(s)
Mom´s Supporting Mom
Other Intervention Name(s)
MSM
Intervention Description
A preventive peer consultation intervention for Postpartum Depression.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment As Usual
Other Intervention Name(s)
ETAU
Intervention Description
Referral to treatment in the community, clinical monitoring
Primary Outcome Measure Information:
Title
Treatment gap for postpartum mental disorders
Description
prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
Time Frame
6 weeks postpartum
Title
Pregnancy depressive symptoms
Description
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Time Frame
up to 32 weeks
Title
Postpartum depressive symptoms
Description
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Pregnancy anxiety symptoms
Description
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Time Frame
up to 32 weeks
Title
Postpartum anxiety symptoms
Description
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Time Frame
6 weeks postpartum
Other Pre-specified Outcome Measures:
Title
Psychosocial stress factors
Description
self-rated psychosocial stress factors measured by Prenatal psychosocial profile. Score range 11 - 44, higher score represents worse outcome.
Time Frame
through study completion, an average of 1 year
Title
Prenatal mother-baby attachment
Description
self-report measure of maternal-fetal attachment measured by Prenatal Attachment Inventory
Time Frame
up to 32 weeks
Title
Parenting competences
Description
self-report measure od maternal sense of parenting competence measured by Parenting Sense of Competence Scale
Time Frame
6 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavla Spadova, Ph.D.
Phone
+420 283 088 111
Email
Pavla.Spadova@nudz.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonin Sebela, Ph.D.
Organizational Affiliation
National Institute of Mental Health, Klecany, Czechia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Mental Health
City
Klecany
ZIP/Postal Code
25067
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavla Spadova
Phone
+420 283 088 436
Email
Pavla.Spadova@nudz.cz
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be made available to other researchers.
IPD Sharing Time Frame
After the completion of the study
IPD Sharing Access Criteria
Permission of the PI
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Pregnancy Without Psychosocial Stress
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