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An Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.

NCT04571190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-05-31

No results posted yet for this study

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.

Conditions

  • Pregnancy, High Risk

Interventions

BEHAVIORAL

Prenatal MBSR

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.

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
2021-01-25
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Denmark

Study Locations

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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 NCT04571190 on ClinicalTrials.gov