Mindfulness ProtocolsNCT07364032
Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy
A study testing Mindfulness program and Consultations in people with Mindfulness Protocols and Pregnancy, run by Universite Cote d'Azur at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Protocols, Pregnancy
- What is being tested?
- Mindfulness program and Consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2023to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Mindfulness Protocols, Pregnancy
- Being tested
- Mindfulness program, Consultations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness programBehavioural
6 weeks of mindfulness
ConsultationsOther
6 week of consultation with 1 consultation per week
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness program | Experimental | Not described Receives: Behavioral: Mindfulness program |
| Classical | Sham comparator | Not described Receives: Other: Consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Stress
French version of Short Stress scale (Cungi et al., 2003)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Depression
French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987)
Measured: 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)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Mindfulness
French version of Mindfulness Scale (Brown et Ryan., 2003)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Self efficacy
French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Happiness
French version of Subjective Happiness Scale (Lyubomirsky \& Lepper, 1997)
Measured: 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)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Prenatal Attachment
French version of Prenatal Attachment Inventory, (Muller, 1993)
Measured: Questionnaire will be completed at day 0 and 6 weeks later.
Secondary outcomes (3)
Cries of the baby
French Version Colic infant questionnaire (Bellaiche et al., 2021)
Measured: 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)
Measured: 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)
Measured: video at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start31 Mar 2023
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mindfulness ProtocolsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite Cote d'Azur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Beauvois, Universite Cote d'Azur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364032
- Sponsor's protocol ID
- CB-PCG-2022
- Other IDs
- ANR-15-IDEX-01
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beauvois C, Soubelet A. A randomized controlled trial comparing a mindfulness-based program with standard therapeutic follow-up during pregnancy: Effects on maternal mental health, infant outcomes, and mother-infant attachment. Contemp Clin Trials. 2026 Jul 8;168:108401. doi: 10.1016/j.cct.2026.108401. Online ahead of print.
PubMed 42419504
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07364032
- Acronym / sponsor ID
- CB-PCG-2022
- Conditions
- Mindfulness Protocols, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universite Cote d'AzurUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness program | Experimental | Behavioral: Mindfulness program |
| Classical | Sham comparator | Other: Consultations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness program6 weeks of mindfulness | Behavioural | Mindfulness program |
| Consultations6 week of consultation with 1 consultation per week | Other | Classical |
Primary outcome
Anxiety
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020)
Stress
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Short Stress scale (Cungi et al., 2003)
Depression
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987)
Sleep disorders
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of The Pittsburgh sleep quality index, (Buysse et al., 1989)
Mindfulness
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Mindfulness Scale (Brown et Ryan., 2003)
Self efficacy
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995)
Happiness
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Subjective Happiness Scale (Lyubomirsky \& Lepper, 1997)
Satisfaction of life
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of The Satisfaction with Life Scale (Diener et al., 1985)
Prenatal Attachment
Time frame: Questionnaire will be completed at day 0 and 6 weeks later.
French version of Prenatal Attachment Inventory, (Muller, 1993)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 42419504Beauvois C, Soubelet A. A randomized controlled trial comparing a mindfulness-based program with standard therapeutic follow-up during pregnancy: Effects on maternal mental health, infant outcomes, and mother-infant attachment. Contemp Clin Trials. 2026 Jul 8;168:108401. doi: 10.1016/j.cct.2026.108401. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness program and Consultations in people with Mindfulness Protocols and Pregnancy, run by Universite Cote d'Azur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Questionnaire will be completed at day 0 and 6 weeks later.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.