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SMART Mom for Pregnancy

N/A
Waitlist Available
Led By Brittain L Mahaffey, PhD
Research Sponsored by Stony Brook University
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 baseline, 8 weeks post enrollment, 20 weeks post enrollment
Awards & highlights

Study Summary

This trial will evaluate two different online programs to help pregnant women manage stress. The first program is based on cognitive behavioral therapy and the second is a social support group. Outcomes will be assessed after the program is completed and six months later.

Eligible Conditions
  • Pregnancy
  • Anxiety
  • Postpartum Depression
  • Stress

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks post enrollment, 20 weeks post enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks post enrollment, 20 weeks post enrollment 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 perceived stress as indexed by Perceived Stress Scale (PSS) score
Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score
Secondary outcome measures
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Measure of Current Status-Form A (MOCS-A)
Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety
+1 more
Other outcome measures
Birthweight
Gestational Age

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.
Group II: Treatment as usualActive Control1 Intervention
Participants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SMART Mom
2021
N/A
~80

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,246 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,662 Total Patients Enrolled
Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,448 Total Patients Enrolled

Frequently Asked Questions

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

How many participants have been admitted to this trial thus far?

"Affirmative. According to the information available on clinicaltrials.gov, this trial is still recruiting individuals and was first listed on April 1st 2021. A total of 60 patients need to be recruiter from a single location before it can start."

Answered by AI

What are the key goals of this experiment?

"This trial will observe changes in maternal distress as indicated by scores on the NuPDQ over a baseline and two 8-week intervals. Secondary outcome metrics include PROMIS V1 Emotional Distress-Depression, PROMIS V1 Emotional Distress-Anxiety, and MOCS Form A; all of which measure stress response characteristics with higher values indicating greater distress or worse coping mechanisms."

Answered by AI

Are new participants welcomed for this experiment at present?

"Affirmative. Clinicaltrials.gov provides verification that this medical trial, which was originally published on April 1st 2021, is currently recruiting participants. 60 patients must be sourced from a single site for the study to succeed."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Stony Brook University Calm-Mom Study
Brittain Lynn Mahaffey 2021. "The Stony Brook University Calm-Mom Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04018625.
~20 spots leftby Apr 2025
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