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STEP-COVID for Maternal Distress

Q: Could you elaborate on the potential risks and benefits of using STEP-COVID?

<p>The safety of STEP-<a href="https://www.withpower.com/clinical-trials/covid">COVID</a> was assessed at a value of 1 since this is an early stage trial. As such, there is only minimal data to support its efficacy and security.</p>

Phase 1

Waitlist Available

Research Sponsored by Université du Québec à Trois-Rivières

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months.

Awards & highlights

Study Summary

This trial will help pregnant women during the COVID-19 pandemic to better cope with their emotions.

Eligible Conditions

Prenatal Stress
Maternal Distress
Coronavirus Pandemic
Mental Health
Mental Health Issue

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in affective states from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum

Change in psychological distress from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum

Level of satisfaction concerning the intervention

+2 more

Secondary outcome measures

Change in antenatal attachment

Change in emotion regulation strategies

Change in perception of parental competence

+9 more

Other outcome measures

Personality dysfunctions

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STEP-COVIDExperimental Treatment1 Intervention

Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.

Group II: Usual prenatal caresActive Control1 Intervention

Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Université du Québec à Trois-RivièresLead Sponsor

42 Previous Clinical Trials

4,283 Total Patients Enrolled

Public Health Agency of Canada (PHAC)OTHER_GOV

45 Previous Clinical Trials

97,033 Total Patients Enrolled

Canada Research Chairs Endowment of the Federal Government of CanadaOTHER_GOV

12 Previous Clinical Trials

186 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available openings for enrollees in this clinical experiment?

"According to the information accessible via clinicaltrials.gov, this trial is not currently recruiting participants. Initially posted on September 1st 2020 and last amended on June 14th 2022, there are 1101 other studies looking for volunteers right now."

Answered by AI

What objectives does this research endeavor to achieve?

"This trial's primary outcome is an evaluation of patient satisfaction over a 7-month time frame, beginning in the second trimester and ending at 36 weeks. Secondary outcomes include changes to participants' perception of parental competence, emotion regulation strategies, and self-compassion scores compared with matched control groups who did not participate in the intervention."

Answered by AI

Could you elaborate on the potential risks and benefits of using STEP-COVID?

"The safety of STEP-COVID was assessed at a value of 1 since this is an early stage trial. As such, there is only minimal data to support its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nicolas Berthelot 2020. "STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419167.