Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 2:14 AM
Study NCT ID:
NCT07364032
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020)'}, {'measure': 'Stress', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Short Stress scale (Cungi et al., 2003)'}, {'measure': 'Depression', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987)'}, {'measure': 'Sleep disorders', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of The Pittsburgh sleep quality index, (Buysse et al., 1989)'}, {'measure': 'Mindfulness', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Mindfulness Scale (Brown et Ryan., 2003)'}, {'measure': 'Self efficacy', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995)'}, {'measure': 'Happiness', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Subjective Happiness Scale (Lyubomirsky \\& Lepper, 1997)'}, {'measure': 'Satisfaction of life', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of The Satisfaction with Life Scale (Diener et al., 1985)'}, {'measure': 'Prenatal Attachment', 'timeFrame': 'Questionnaire will be completed at day 0 and 6 weeks later.', 'description': 'French version of Prenatal Attachment Inventory, (Muller, 1993)'}], 'secondaryOutcomes': [{'measure': 'Cries of the baby', 'timeFrame': 'Questionnaires will be completed daily up to 1 and 3 months post partum', 'description': 'French Version Colic infant questionnaire (Bellaiche et al., 2021)'}, {'measure': 'Sleep disturbances', 'timeFrame': 'Questionnaires will be completed at 1 year Post partum', 'description': 'French Version Sleep disturbance scale for children, (Lecuelle et al., 2020)'}, {'measure': 'Post natal attachment', 'timeFrame': 'video at 1 year', 'description': 'French version of Baby Interaction Scale (Beaupuy. 2021) Pediatric Infant Parent Exam (PIPE, Fiese et al., 2001)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness Protocols', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of a 6-week mindfulness meditation program in pregnant women, compared with a psychological support control program.\n\nParticipants in the mindfulness arm will complete one instructor-led meditation session per week and five guided audio meditation sessions at home each week.\n\nThe primary objectives are to determine whether the mindfulness program leads to:\n\nReduced negative affect, including stress, anxiety, depression, and sleep disturbances during pregnancy.\n\nIncreased positive affect, such as mindfulness skills, self-efficacy, happiness, and life satisfaction.\n\nEnhanced maternal-fetal attachment during pregnancy and improved maternal-infant attachment one month postpartum.\n\nImproved mother-infant interaction quality at 3 months postpartum.\n\nMore secure infant attachment at 12 months.\n\nBetter infant outcomes, including reduced crying intensity/duration at 1 and 3 months, and improved sleep quality at 12 months.\n\nOverall, the study evaluates whether the mindfulness program provides greater benefits than a standard parenting support intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 3 and 7.5 months of gestation (12-28 weeks).\n* Ability to speak and read French sufficient to understand study documents and complete questionnaires.\n* Willingness to participate in the study and to be randomized to one of the study groups.\n\nExclusion Criteria:\n\n* Loss of the baby\n* Participation in other prenatal support programs, including prenatal yoga, haptonomy, sophrology, or mindfulness courses.\n* Severe or unstable psychiatric disorder. Inability to understand French or complete study questionnaires.'}, 'identificationModule': {'nctId': 'NCT07364032', 'briefTitle': 'Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': "Universite Cote d'Azur"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CB-PCG-2022'}, 'secondaryIdInfos': [{'id': 'ANR-15-IDEX-01', 'type': 'OTHER_GRANT', 'domain': 'Agence Nationale de la Recherche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness program', 'interventionNames': ['Behavioral: Mindfulness program']}, {'type': 'SHAM_COMPARATOR', 'label': 'Classical', 'interventionNames': ['Other: Consultations']}], 'interventions': [{'name': 'Mindfulness program', 'type': 'BEHAVIORAL', 'description': '6 weeks of mindfulness', 'armGroupLabels': ['Mindfulness program']}, {'name': 'Consultations', 'type': 'OTHER', 'description': '6 week of consultation with 1 consultation per week', 'armGroupLabels': ['Classical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06370', 'city': 'Mouans-Sartoux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clara Beauvois, Psychologist', 'role': 'CONTACT', 'email': 'Clara.BEAUVOIS@univ-cotedazur.fr', 'phone': '+33769634713'}], 'facility': 'Clara Beauvois Cabinet de psychologie', 'geoPoint': {'lat': 43.62101, 'lon': 6.97139}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Universite Cote d'Azur", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Clara Beauvois', 'investigatorAffiliation': "Universite Cote d'Azur"}}}}