Pregnancy Without Psychosocial Stress

NCT04853693 | Unknown

• 1 other identifier: ZD-ZDOVA1-018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.create and pilot a screening program for psychosocial stress in perinatal women in gynecological clinics
2. 2.connect the screening program to the integrated step care system created by the investigators, including peer support, which the investigators will test

Conditions

Depressive Symptoms; Anxiety Disorders and Symptoms; Depression, Postpartum

Outcome Measures

Primary Outcomes (3)

• Treatment gap for postpartum mental disorders

  prevalence of untreated mental health disorders in postpartum women assessed by The Mini-International Neuropsychiatric Interview

  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.

  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.

  6 weeks postpartum

Secondary Outcomes (2)

• Pregnancy anxiety symptoms

  up to 32 weeks

• Postpartum anxiety symptoms

  6 weeks postpartum

Other Outcomes (3)

• Psychosocial stress factors

  through study completion, an average of 1 year

• Prenatal mother-baby attachment

  up to 32 weeks

• Parenting competences

  6 weeks postpartum

Study Arms (2)

Mom´s Supporting Mom (MSM)

EXPERIMENTAL

A preventive intervention that involves psychoeducation and peer techniques described in study detailed description.

Behavioral: Mom´s Supporting Mom

Enhanced Treatment as Usual

ACTIVE COMPARATOR

Referral to treatment in the community and monitoring

Behavioral: Enhanced Treatment As Usual

Interventions

Mom´s Supporting Mom BEHAVIORAL

A preventive peer consultation intervention for Postpartum Depression.

Also known as: MSM

Mom´s Supporting Mom (MSM)

Enhanced Treatment As Usual BEHAVIORAL

Referral to treatment in the community, clinical monitoring

Also known as: ETAU

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- acute medical illness or significant pregnancy complication (based on self-report)
• acute suicidal behavior (based on self-report)

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead

Study Sites (1)

National Institute of Mental Health

Klecany, 25067, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39342905 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Officials

• Antonin Sebela, Ph.D.

  National Institute of Mental Health, Klecany, Czechia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavla Spadova, Ph.D.

CONTACT

+420 283 088 111; Pavla.Spadova@nudz.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and person administering the outcome measures are blind to participant group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: One receives MSM prevention intervention and the other group receives Enhanced Treatment as Usual (referral and monitoring).

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 21, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After the completion of the study
• Access Criteria: Permission of the PI

Locations

CZ (1)