Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness program, Consultations.
- Who it may be relevant to
- Registry conditions: Mindfulness Protocols, Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This study aims to evaluate the effects of a 6-week mindfulness meditation program in pregnant women, compared with a psychological support control program. Participants in the mindfulness arm will complete one instructor-led meditation session per week and five guided audio meditation sessions at home each week. The primary objectives are to determine whether the mindfulness program leads to: Reduced negative affect, including stress, anxiety, depression, and sleep disturbances during pregnancy. Increased positive affect, such as mindfulness skills, self-efficacy, happiness, and life satisfaction. Enhanced maternal-fetal attachment during pregnancy and improved maternal-infant attachment one month postpartum. Improved mother-infant interaction quality at 3 months postpartum. More secure infant attachment at 12 months. Better infant outcomes, including reduced crying intensity/duration at 1 and 3 months, and improved sleep quality at 12 months. Overall, the study evaluates whether the mindfulness program provides greater benefits than a standard parenting support intervention.
Interventions
- Behavioral Mindfulness program
6 weeks of mindfulness - Other Consultations
6 week of consultation with 1 consultation per week
Primary outcome measures
- Anxiety [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Stress [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Depression [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Sleep disorders [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Mindfulness [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Self efficacy [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Happiness [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Satisfaction of life [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
- Prenatal Attachment [Time frame: Questionnaire will be completed at day 0 and 6 weeks later.]
Secondary outcome measures (3)
- Cries of the baby [Time frame: Questionnaires will be completed daily up to 1 and 3 months post partum]
- Sleep disturbances [Time frame: Questionnaires will be completed at 1 year Post partum]
- Post natal attachment [Time frame: video at 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clara Beauvois Cabinet de psychologie — Mouans-Sartoux
Publications
- Beauvois C, Soubelet A, Ranieri C. 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. Contemp Clin Trials. 2026 Jul 8:108401. doi: 10.1016/j.cct.2026.108401. Online ahead of print. PMID 42419504
Identifiers
NCT: NCT07364032 · CB-PCG-2022 · ANR-15-IDEX-01