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Pregnancy Without Psychosocial Stress

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ClinicalTrials.gov Identifier: NCT04853693
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health, Czech Republic

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

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Disorders and Symptoms Depression, Postpartum Behavioral: Mom´s Supporting Mom Behavioral: Enhanced Treatment As Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator and person administering the outcome measures are blind to participant group
Primary Purpose: Prevention
Official Title: Pregnancy Without Psychosocial Stress - the Earliest Prevention of Mental Disorders and Toxic Stress in Children
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mom´s Supporting Mom (MSM)
A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.
Behavioral: Mom´s Supporting Mom
A preventive peer consultation intervention for Postpartum Depression.
Other Name: MSM

Active Comparator: Enhanced Treatment as Usual
Referral to treatment in the community and monitoring
Behavioral: Enhanced Treatment As Usual
Referral to treatment in the community, clinical monitoring
Other Name: ETAU




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Pregnancy anxiety symptoms [ Time Frame: up to 32 weeks ]
    self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.

  2. Postpartum anxiety symptoms [ Time Frame: 6 weeks postpartum ]
    self-rated anxiety symptomatology measured by Perinatal Anxiety Screening Scale. Score range 0-93, higher score represents worse outcome.


Other Outcome Measures:
  1. Psychosocial stress factors [ Time Frame: 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.

  2. Prenatal mother-baby attachment [ Time Frame: up to 32 weeks ]
    self-report measure of maternal-fetal attachment measured by Prenatal Attachment Inventory

  3. Parenting competences [ Time Frame: 6 weeks postpartum ]
    self-report measure od maternal sense of parenting competence measured by Parenting Sense of Competence Scale



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853693


Contacts
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Contact: Pavla Spadova, Ph.D. +420 283 088 111 Pavla.Spadova@nudz.cz

Locations
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Czechia
National Institute of Mental Health Recruiting
Klecany, Czechia, 25067
Contact: Pavla Spadova    +420 283 088 436    Pavla.Spadova@nudz.cz   
Sponsors and Collaborators
National Institute of Mental Health, Czech Republic
Investigators
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Principal Investigator: Antonin Sebela, Ph.D. National Institute of Mental Health, Klecany, Czechia
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Responsible Party: National Institute of Mental Health, Czech Republic
ClinicalTrials.gov Identifier: NCT04853693    
Other Study ID Numbers: ZD-ZDOVA1-018
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be made available to other researchers.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After the completion of the study
Access Criteria: Permission of the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders