Depressive SymptomsNCT04853693
Pregnancy Without Psychosocial Stress
A study testing Mom´s Supporting Mom and Enhanced Treatment As Usual in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety Disorders and Symptoms, Depression, Postpartum
- What is being tested?
- Mom´s Supporting Mom and Enhanced Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Edinburgh Postpartum Depression Scale score ≥10.
- participant identified through the ACTIVITY 1 of the study
Who cannot join
- acute medical illness or significant pregnancy complication (based on self-report)
- acute suicidal behavior (based on self-report)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
National Institute of Mental Health
Klecany, 25067
Pavla Spadova, +420 283 088 436, Pavla.Spadova@nudz.cz
About this study
Official title: 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.
Read more
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
Read the 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 %.
- Being tested
- Mom´s Supporting Mom, Enhanced Treatment As Usual
- Medical subject headings
- Depression, Anxiety Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom´s Supporting MomBehavioural
Also called MSM
A preventive peer consultation intervention for Postpartum Depression.
Enhanced Treatment As UsualBehavioural
Also called ETAU
Referral to treatment in the community, clinical monitoring
| Study group | Role | What they receive |
|---|---|---|
| Mom´s Supporting Mom (MSM) | Experimental | A preventive intervention that involves psychoeducation and peer techniques described in study detailed description. Receives: Behavioral: Mom´s Supporting Mom |
| Enhanced Treatment as Usual | Active comparator | Referral to treatment in the community and monitoring Receives: Behavioral: Enhanced Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment gap for postpartum mental disorders
prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
Measured: 6 weeks postpartum
Pregnancy depressive symptoms
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Measured: up to 32 weeks
Postpartum depressive symptoms
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
Measured: 6 weeks postpartum
Secondary outcomes (2)
Pregnancy anxiety symptoms
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Measured: up to 32 weeks
Postpartum anxiety symptoms
self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonin Sebela, Ph.D., Principal investigator, National Institute of Mental Health, Klecany, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853693
- Sponsor's protocol ID
- ZD-ZDOVA1-018
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be made available to other researchers.
Publications
Horakova A, Kuklova M, Hrdlickova K, Nemcova H, Knytl P, Kostylkova L, Sebela A. Effectiveness of the mom supports mom peer support intervention in treating antenatal mental health difficulties in women. Midwifery. 2024 Dec;139:104198. doi: 10.1016/j.midw.2024.104198. Epub 2024 Sep 24.
PubMed 39342905
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children
- ClinicalTrials.gov ID
- NCT04853693
- Acronym / sponsor ID
- ZD-ZDOVA1-018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
| Arm | Type | Receives |
|---|---|---|
| Mom´s Supporting Mom (MSM) | Experimental | Behavioral: Mom´s Supporting MomA preventive intervention that involves psychoeducation and peer techniques described in study detailed description. |
| Enhanced Treatment as Usual | Active comparator | Behavioral: Enhanced Treatment As UsualReferral to treatment in the community and monitoring |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- sex-female
- pregnancy
- woman is registered during and after pregnancy in one of 20 study gynecological outpatient clinics
- signing informed consent
- email address ownership
Key exclusion criteria (2 listed)
- acute medical illness or significant pregnancy complication (based on self-report)
- acute suicidal behavior (based on self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mom´s Supporting MomAlso: MSMA preventive peer consultation intervention for Postpartum Depression. | Behavioural | Mom´s Supporting Mom (MSM) |
| Enhanced Treatment As UsualAlso: ETAUReferral to treatment in the community, clinical monitoring | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Treatment gap for postpartum mental disorders
Time frame: 6 weeks postpartum
prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview
Pregnancy depressive symptoms
Time frame: 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
Time frame: 6 weeks postpartum
self-rated depressive symptomatology measured by Edinburgh Postnatal Depression Scale. Score range 0-30, higher score represents worse outcome.
2 secondary outcomes
Pregnancy anxiety symptoms
Time frame: up to 32 weeks
Postpartum anxiety symptoms
Time frame: 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 39342905Horakova A, Kuklova M, Hrdlickova K, Nemcova H, Knytl P, Kostylkova L, Sebela A. Effectiveness of the mom supports mom peer support intervention in treating antenatal mental health difficulties in women. Midwifery. 2024 Dec;139:104198. doi: 10.1016/j.midw.2024.104198. Epub 2024 Sep 24.
- Individual participant dataSharing planned: Yes. De-identified data may be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonin Sebela, Ph.D. principal investigator
National Institute of Mental Health, Klecany, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom´s Supporting Mom and Enhanced Treatment As Usual in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavla Spadova, Ph.D. (+420 283 088 111, Pavla.Spadova@nudz.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment gap for postpartum mental disorders (time frame: 6 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.