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Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.

NCT05300646 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2022-03-29

No results posted yet for this study

Summary

The aim of the study is to address the need for a wider array of evidence-based and non-pharmacological options to improve mental health in a psycho-socially highly vulnerable group of pregnant women. In more detail, the primary outcome is to estimate the effect of prenatal Mindfulness-Based Stress Reduction (MBSR) as an add-on to usual care on mental well-being when compared to usual care alone. Second, to estimate the effect of prenatal MBSR on perceived stress and symptoms of depression and anxiety, and third to explore the effect on maternal bonding and childbirth, e.g. gestational age and experience of childbirth. Finally, to examine the mediating effect of mindfulness and self-compassion on the primary outcome.

Conditions

  • Perinatal Mental Health
  • Pregnancy Related

Interventions

BEHAVIORAL

Prenatal mindfulness-based stress reduction

An adapted mindfulness-based stress reduction (MBSR) program with a particular focus on pregnancy and early motherhood.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-07-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT05300646 on ClinicalTrials.gov