Evidence map›Paper›PMID 40544301›Full record

ArticlePilot and feasibility studies2025

Mindfulness-Based Stress Reduction adapted to pregnant women with psychosocial vulnerabilities - a randomized feasibility trial in a Danish hospital-based outpatient setting.

Sine Skovbjerg, Michelle Kolls, Anette Kjærbye-Thygesen, Lone Overby Fjorback

Registry-linked trialAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04571190 (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), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04571190 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of AarhusRan2021 to 2022Enrolled73ConditionsPregnancy, High RiskArmsPrenatal MBSR
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Sine SkovbjergThe Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. sine.skovbjerg@clin.au.dk.ORCID http://orcid.org/0000-0003-0616-3137
Michelle KollsDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre, Denmark.
Anette Kjærbye-ThygesenDepartment of Obstetrics and Gynaecology, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre, Denmark.
Lone Overby FjorbackThe Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSupporting prenatal mental health in women with a preconception history of mental disorders or psychosocial vulnerability is important for a positive transition to parenthood. There is a need for more evidence-based and non-pharmacological mental health interventions in antenatal care. The primary objective of this trial was to evaluate the feasibility of prenatal MBSR, which is an adaption of Mindfulness-based stress reduction (MBSR). This to inform a randomized controlled trial. METHODS/

designThe trial was conducted at an obstetric outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark. The outpatient clinic specializes in antenatal care for pregnant women with psychosocial vulnerabilities. Pregnant women were randomly assigned to an intervention group receiving prenatal MBSR or a waitlist control group. The primary outcome was the feasibility of a full-scale randomized controlled trial (RCT). Second, to examine trends in self-reported outcomes, i.e., mental well-being, perceived stress, anxiety, depression, decentering, reflective functioning, mindfulness, and self-compassion.

resultsOf 123 eligible women, 73 consented to participate (59.3%). The majority (75.3%) were nulliparous. The mean age was 30.7 (SD 4.7) years, and most participants were employed (74%) and living with a partner (93.1%) at the time of recruitment. The majority of participants had a history of one or more mental disorders. Most frequently depression or an anxiety disorder. For the intervention group (n = 37), 54.1% completed the prenatal MBSR program. The loss to follow-up was 56.8% for the intervention group (n = 21) and 50% for the waitlist control group (n = 18). For the secondary outcomes, all variables except for reflective functioning pointed in the expected direction, e.g., improved mental well-being, reduced mental distress, and more self-compassion.

conclusionsThe results from this trial suggest that prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of an RCT. Strategies for improving adherence and reducing the extent of missing data would be advisable in a future RCT. Overall, there is a need for more evidence-based and non-pharmacological interventions addressing prenatal mental health. Results from a future RCT could thus be of relevance to antenatal care.

trial registrationNCT04571190, September 30, 2020 (ClinicalTrials.gov).

Indexed as

Feasibility trialMBSRMindfulnessMindfulness-based stress reductionPregnancyPrenatal MBSRPrenatal mental healthPrenatal mindfulness-based stress reductionPsychosocial vulnerability

Identifiers

PMID40544301
PMCPMC12181856

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.