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
Pilot and Feasibility Studies June 21, 2025 DOI: 10.1186/s40814-025-01670-0 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Feasibility trial Randomized Peer reviewed |
|---|---|
| Sample size | 73 |
| Population | Pregnant women with psychosocial vulnerabilities at an obstetric outpatient clinic in Copenhagen, Denmark |
| Topics | Meditation |
| Keywords | Feasibility trial Mindfulness-based stress reduction Pregnancy Prenatal mbsr Prenatal mental health Psychosocial vulnerability Mental well-being Reduced stress Pregnant women Feasible intervention |
| Registration | NCT04571190 |
| Key findings | Prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of a full-scale randomized controlled trial, though adherence was low and loss to follow-up high. |
Abstract
Supporting 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. The 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. Of 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. The 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. NCT04571190, September 30, 2020 (ClinicalTrials.gov).
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |
Citations in the library
Cites 14
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- Self-awareness, self-regulation, and self-transcendence (S-ART): a framework for understanding the neurobiological mechanisms of mindfulness Frontiers in Human Neuroscience 2012
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
- Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse JAMA Psychiatry April 28, 2016
- Home practice in Mindfulness-Based Cognitive Therapy and Mindfulness-Based Stress Reduction: A systematic review and meta-analysis of participants' mindfulness practice and its association with outcomes Behaviour Research and Therapy May 10, 2017
and 9 more in the library