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The Stony Brook University Calm-Mom Study

NCT04018625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-08-01

No results posted yet for this study

Summary

The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (\<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.

Conditions

  • Pregnancy Related
  • Stress, Psychological
  • Anxiety
  • Perinatal Depression

Interventions

BEHAVIORAL

SMART Mom

SMART Pregnancy is an 8-session online stress management program offered in a group format. SMART Pregnancy is an adaptation of the Stress Management and Resiliency Training Program (Park et al., 2012).

BEHAVIORAL

Mama Support

Participants will be enrolled in an 8-week time and attention matched, process-based support group.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Stony Brook University

    lead OTHER

Principal Investigators

  • Brittain L Mahaffey, PhD · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018625 on ClinicalTrials.gov