Comparison Between a Mindfulness-Based Program and Standard Therapeutic 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 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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Mindfulness Protocols
• Intervention / Treatment: Behavioral: Mindfulness program; Other: Consultations

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mouans-Sartoux, France, 06370
    • Recruiting
    • Clara Beauvois Cabinet de psychologie
    • Contact: Clara Beauvois, Psychologist; Phone Number: +33769634713; Email: Clara.BEAUVOIS@univ-cotedazur.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness program	Behavioral: Mindfulness program; 6 weeks of mindfulness
Sham Comparator: Classical	Other: Consultations; 6 week of consultation with 1 consultation per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020)	Questionnaire will be completed at day 0 and 6 weeks later.
Stress	French version of Short Stress scale (Cungi et al., 2003)	Questionnaire will be completed at day 0 and 6 weeks later.
Depression	French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987)	Questionnaire will be completed at day 0 and 6 weeks later.
Sleep disorders	French version of The Pittsburgh sleep quality index, (Buysse et al., 1989)	Questionnaire will be completed at day 0 and 6 weeks later.
Mindfulness	French version of Mindfulness Scale (Brown et Ryan., 2003)	Questionnaire will be completed at day 0 and 6 weeks later.
Self efficacy	French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995)	Questionnaire will be completed at day 0 and 6 weeks later.
Happiness	French version of Subjective Happiness Scale (Lyubomirsky & Lepper, 1997)	Questionnaire will be completed at day 0 and 6 weeks later.
Satisfaction of life	French version of The Satisfaction with Life Scale (Diener et al., 1985)	Questionnaire will be completed at day 0 and 6 weeks later.
Prenatal Attachment	French version of Prenatal Attachment Inventory, (Muller, 1993)	Questionnaire will be completed at day 0 and 6 weeks later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cries of the baby	French Version Colic infant questionnaire (Bellaiche et al., 2021)	Questionnaires will be completed daily up to 1 and 3 months post partum
Sleep disturbances	French Version Sleep disturbance scale for children, (Lecuelle et al., 2020)	Questionnaires will be completed at 1 year Post partum
Post natal attachment	French version of Baby Interaction Scale (Beaupuy. 2021) Pediatric Infant Parent Exam (PIPE, Fiese et al., 2001)	video at 1 year

Collaborators and Investigators

• Sponsor: Universite Cote d'Azur

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Professional Practice; Organization and Administration; Health Services Administration; Referral and Consultation
• Other Study ID Numbers: CB-PCG-2022; ANR-15-IDEX-01 (Other Grant/Funding Number: Agence Nationale de la Recherche)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No