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NCT05300646
Mindfulness-Based Stress Reduction for Psycho-socially Vulnerable Pregnant Women.
NA trial testing Prenatal mindfulness-based stress reduction in Perinatal Mental Health in 238 participants. Status unknown.
31 July 2024
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 238 |
| Start date | 1 March 2022 |
| Primary completion | 31 July 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Prenatal mindfulness-based stress reduction
Conditions studied
- Perinatal Mental Health — all drugs for Perinatal Mental Health →
- Pregnancy Related — all drugs for Pregnancy Related →
Sponsor
University of Aarhus
Who can join
18 and older, female only, with Perinatal Mental Health or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting.
Skovbjerg S, Sumbundu A, Kolls M, Kjærbye-Thygesen A, et al · · 2023 · cited 6× · PMID 37838672 · DOI 10.1186/s12906-023-04194-3
Verify or expand the search:
- PubMed search for NCT05300646
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05300646 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 29 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05300646.
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