CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Prenatal MBSRbehavioral
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/NCT04571190
NCT04571190N/ACompleted

An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women - a Protocol for a Randomized Feasibility Study in a Danish Hospital-based Outpatient Setting

University of Aarhus·interventional·Posted Sep 30, 2020·Updated May 31, 2022

In Brief

A clinical study evaluating Prenatal MBSR for Pregnancy, High Risk. Completed, enrolled 73 participants across 1 site.

Detailed Summary

This protocol is for a feasibility study of an adapted mindfulness-based stress reduction (MBSR) program for high-risk pregnant women. The aim is to address the need for more evidence-based options for mental healthcare in pregnancy. MBSR has good evidence in reducing stress, anxiety and depression in both clinical and non-clinical populations, but has not yet been adapted for high-risk pregnancies. The purpose is to evaluate the feasibility, acceptability and potential intervention effects of an adapted MBSR program compared to usual care to inform a randomized controlled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 30, 2020
Enrollment StartJan 25, 2021
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.8 years ago

Interventions

Prenatal MBSRbehavioral

Prenatal MBSR is an adaptation to the original MBSR program. The essential program elements characterizing MBSR is maintained and integrated with the particular context and specific needs of this group of pregnant women. Adaptations to the MBSR program draw upon both empirical data as well as existing research and theory.