Mindfulness program versus standard psychological follow-up during pregnancy
A Randomized Controlled Trial Comparing a Mindfulness-based Program With Standard Therapeutic Follow-up During Pregnancy: Effects on Maternal Well-being, Infant Outcomes, and Mother-Infant Attachment
This project will see if a 6-week mindfulness meditation program helps pregnant women (12–28 weeks) reduce stress, anxiety, sleep problems, and improve mood and bonding compared with standard therapeutic follow-up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universite Cote d'Azur Academic / other |
| Locations | 1 site (Mouans-Sartoux) |
| Trial ID | NCT07364032 on ClinicalTrials.gov |
What this trial studies
Pregnant women between 12 and 28 weeks gestation are randomized to a 6-week mindfulness meditation program or to standard psychological follow-up. The mindfulness arm includes one instructor-led meditation session per week plus five guided audio meditations to do at home each week. Outcomes measured include maternal negative and positive affect, maternal-fetal and maternal-infant attachment at multiple postpartum timepoints, mother-infant interaction quality, and infant sleep and crying measures up to 12 months. The program is delivered at a single site in Mouans-Sartoux, France, with follow-up assessments through the first year postpartum.
Who should consider this trial
Good fit: Pregnant women 12–28 weeks gestation who can read and speak French, are willing to be randomized, and are not already participating in other prenatal support programs are ideal candidates.
Not a fit: Women who have experienced pregnancy loss, are already enrolled in prenatal mindfulness or similar programs, or have severe unstable psychiatric disorders are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If effective, the program could lower maternal stress and mood symptoms during pregnancy and strengthen mother-infant bonding and early infant outcomes.
How similar studies have performed: Previous prenatal mindfulness studies have shown reductions in maternal stress and anxiety, but evidence for effects on infant attachment and longer-term infant outcomes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women between 3 and 7.5 months of gestation (12-28 weeks). * Ability to speak and read French sufficient to understand study documents and complete questionnaires. * Willingness to participate in the study and to be randomized to one of the study groups. Exclusion Criteria: * Loss of the baby * Participation in other prenatal support programs, including prenatal yoga, haptonomy, sophrology, or mindfulness courses. * Severe or unstable psychiatric disorder. Inability to understand French or complete study questionnaires.
Where this trial is running
Mouans-Sartoux
- Clara Beauvois Cabinet de psychologie — Mouans-Sartoux, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.