CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Mothers and Babies (Enhanced)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03615261
NCT03615261N/ACompleted

Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach: An Intervention Feasibility and Acceptability Pilot

Northwestern University·interventional·Posted Aug 3, 2018·Updated Oct 4, 2021

In Brief

A clinical study evaluating Mothers and Babies (Enhanced) for Pregnancy and Prenatal Stress. Completed, enrolled 17 participants across 1 site.

Detailed Summary

The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). The technology that the investigators will test includes wearable heart rate sensors, smartphone text message surveys, and intervention materials delivered through text message.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartJul 30, 2018
Primary CompletionJan 31, 2019
Study CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.9 years ago

Interventions

Mothers and Babies (Enhanced)behavioral

The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions.