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STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic

U

Université du Québec à Trois-Rivières

Status and phase

Completed
Phase 1

Conditions

Maternal Distress
Prenatal Stress
Mental Health Issue
Psychological
COVID-19 Pandemic

Treatments

Behavioral: STEP-COVID

Study type

Interventional

Funder types

Other

Identifiers

NCT05419167
STEP COVID

Details and patient eligibility

About

STEP-COVID (Supporting the Transition to and Engagement in Parenthood during the COVID-19 pandemic) is a manualized group intervention for pregnant women during the COVID-19 pandemic designed to foster emotion regulation and reflective capacities in participants.

Full description

The program aims to (a) support mentalization in relation to oneself, motherhood and the relationship with the child to be born, (b) reduce isolation by allowing participants to exchange about the positive aspects and the challenges of pregnancy and motherhood with other women, (c) explore what pregnant women are going through in the context of the pandemic, (d) allow participants to repossess their experience of pregnancy in the current context of insecurity and fear, and (e) consider new ways of coping with stress and unpleasant emotions. The program is manualized and uses structured activities based on theoretical grounds and empirical research during which facilitators share information, animate reflective activities, and facilitate exchanges.

Enrollment

100 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Pregnant women ages 18+ years
  • Interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting.
  • Must speak French as their first language

Exclusion criteria

  • Severe psychiatric disorders (schizophrenia, bipolar disorder)
  • Severe emotional dysregulation
  • Current self-harm
  • Not sure to keep the child
  • High level of hostility

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

STEP-COVID
Experimental group
Description:
Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.
Treatment:
Behavioral: STEP-COVID
Usual prenatal cares
No Intervention group
Description:
Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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