Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000679684
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
23/06/2023
Date last updated
23/06/2023
Date data sharing statement initially provided
23/06/2023
Date results information initially provided
23/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The mindful pregnancy and mother-baby relationship project
Scientific title
Investigating the value of mindfulness to support maternal mental health and mother-infant relationship during pregnancy and post-birth
Secondary ID [1] 309465 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The Prenatal Mindfulness Relationship-Based (PMRB) program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prenatal and postnatal depression 329721 0
Prenatal and postnatal anxiety 329722 0
Prenatal and postnatal stress 329723 0
Maternal mindfulness 329724 0
Condition category
Condition code
Mental Health 326615 326615 0 0
Depression
Mental Health 326616 326616 0 0
Anxiety
Reproductive Health and Childbirth 326619 326619 0 0
Childbirth and postnatal care
Public Health 326620 326620 0 0
Health promotion/education
Public Health 326621 326621 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online weekly 9-week Prenatal Mindfulness- Relationship-Based (PMRB) program

a) Informational materials used
The PMRB program draws upon the eight-week Mindfulness-Based Stress Reduction (MBSR) developed by Dr Kabat-Zinn in the early 1980s at the University of Massachusetts Medical Center, the first and perhaps the most well-known mindfulness-based intervention to gain empirical support in the treatment of psychological symptoms. The background of the program is described in my book (Routledge, 2021).
In the PMRB program, the teaching of mindfulness is integrated with the following
knowledge:
• Breathing technique and meditation, mind-body pain and stress coping strategies for childbirth and awareness skills for coping with daily life stress.
• Prenatal and perinatal education, including prenatal development and the baby as a sentience being, basic knowledge of psychobiological processes of pregnancy, childbirth, postpartum adjustment, breastfeeding/feeding, psychobiological needs of the baby, and mother-baby sensorimotor modulation techniques during pregnancy using maternal touch, vocalization, and infant’s movements.
b) Procedures and activities.
Formal mindfulness meditation instruction is given by the program conductor (myself) and practiced in each class for the last 20-25 minutes, followed by the participants feedback of their experience. A key innovative element of the PMRB is the focus on mother-baby connection from a new mind-body perspective based on the mother’s awareness of her body (interoception) as well as of her unborn baby as a sentient being, capable of engaging in bidirectional interactions. This reflects a new concept of prenatal attachment based on shifting attention from when “the baby arrives to the baby is already here and I am connected to my baby”. In addition to attending the online classes, participants are asked to commit to practicing some home exercises, including free of charge guided mindfulness meditation videos from YouTube or created by me and particularly designed for pregnancy throughout the course. Furthermore, as part of the home exercises, participants are invited to write a diary of their perceptions of the baby’s movements and cues, and a dialogue with the baby to further enhance interoception (embodied awareness and inward focus), sense of presence, sensitivity and reflective functioning, connection with the baby, and relaxation. In addition, they are invited to reflect upon these experiences and practice mindfulness and baby connect whenever possibly in their daily life activities. The recommended amount of daily home exercises is approximately 30 minutes, 6 days a week. The benefits of these exercises and the importance of continued practice are explained during the sessions.

Table 1 Components of the Prenatal Mindfulness Relationship-Based (PMRB) program.

Sessions Focus of session
number

1 Discovering the present moment
2 Everything is mindfulness
3 Discovering embodiment, stress and how it affects us
4 Learning acceptance and emotional availability
5 Self-compassion, self-love and intentionality
6 Cultivating nurturing emotions and conscious communication in the womb
7 Letting go
8 A mindful pregnancy, birth and life
9 Post-partum reunion and birth story

c) Who will deliver the intervention
The intervention is delivered by myself, the program creator, who is also the PhD candidate piloting it. I am a certified Youth Mindfulness practitioner, clinical psychologist, MA, and author.
d) Mode of delivery
The PMRB program is delivered on an online platform (Zoom).
e) Number of times the intervention is delivered and over what period of time
The program is delivered in 9 sessions. The traditional number of weekly sessions of a mindfulness-based intervention – eight - has been kept, and the length of each weekly session from 20+ weeks to approximately 36-week gestation is two hours. A group reunion session was supposed to be held 10-12 weeks post-partum, before the third survey, but the proposed time was not suitable for all the new mothers busy with their newborn infants. Hence, individual and pair sessions are offered.
f) The location/setting where the intervention occurs
Online, Zoom, Australia.
g) Strategies used to assess or monitor adherence or fidelity of the intervention
Fidelity was not monitored using audio or video recording to ensure confidentiality. Transcripts were used for the qualitative analysis.
Compliance was measured by noting participant attendance and by questions about the frequency and length of the mindfulness practice during the last week. It was recommended not to miss more than two sessions. Most participants missed 1 or 2 sessions and all participants completed the prenatal program. Only one participant did not attend the postpartum session and completed the follow-up due to unknown reasons. The importance of continued practice and a minimum period of six weeks to induce brain and habitual pattern changes and mental health improvements was explained (Bowen et al., 2014; Guardino et al., 2014; Woolhouse et al., 2014).

References:

Bowen, A., Baetz, M., Schwartz, L., Balbuena, L., & Muhajarine, N. (2014). Antenatal group
therapy improves worry and depression symptoms. The Israel Journal of Psychiatry and
Related Sciences, 51 (3), 2260231.
Guardino, C.M., Dunkel Schetter, C., Bower, J.E., Lu M.C., & Smalley, S.L. (2014).
Randomised controlled pilot trial of mindfulness training for stress reduction during
pregnancy. Psychology and Health. 29 (3), 334-49. doi: 10.1080/08870446.2013.852670.
Epub 2013 Nov 1. PMID: 24180264; PMCID: PMC4160533.
Kabat-Zinn, J., Massion, A.O., Kristeller, J., Peterson, L.G., Fletcher K.E., Pbert, L.,
Lenderking, W.R., & Santorelli, S. F. (1992). Effectiveness of a meditation-based stress
reduction program in the treatment of anxiety disorders. American Journal of Psychiatry.
149 (7), 936-43.
Sansone, A. (2021). Sansone, A. (2021). Cultivating mindfulness to raise children who thrive:
Why human connection from before birth matters. Routledge.
Woolhouse, H., Mercuri, K., Judd, F., & Brown, S. J. (2014). Antenatal mindfulness
intervention to reduce depression, anxiety and stress: a pilot randomised
controlled trial of the MindBabyBody program in an Australian tertiary maternity
hospital. BMC Pregnancy and Childbirth, 14, 369.
Intervention code [1] 325887 0
Treatment: Other
Comparator / control treatment
No control group/Feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334486 0
Maternal mindfulness

Maternal mindfulness was measured using the Five Facets Mindfulness Questionnaire (FFMQ) (Baer et al., 2006),
Timepoint [1] 334486 0
Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)
Secondary outcome [1] 420835 0
Interoception
Maternal interoception or interoceptive awareness was measured by using the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAYA) (Melhing et al., 2018).
Timepoint [1] 420835 0
Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)
Secondary outcome [2] 422891 0
Mother-infant relationship during pregnancy

Mother-infant relationship during pregnancy was measured using the Maternal-Foetal Attachment Scale (MFAS; Cranley, 1981
Timepoint [2] 422891 0
Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Secondary outcome [3] 422892 0
Mother-infant relationship postpartum

It was measured using the Emotional Availability Self-Report (EA-SR; Biringer et al., 2002; Vliegen, et al., 2005), an outcome measure assessing maternal emotional availability, which is considered a good indicator of a favourable mother-infant relationship during the first year of a child’s life (Vliegen et al., 2009).
Timepoint [3] 422892 0
Time point 3: 10-12 weeks postpartum (follow-up)
Secondary outcome [4] 423324 0
Maternal Depression

Maternal depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS),
Timepoint [4] 423324 0
Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)
Secondary outcome [5] 423325 0
Anxiety and Stress

The second measure of maternal mental health was the Depression Anxiety Stress Scale-21 Short Form (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [5] 423325 0
Time point 1: 20+ weeks gestation
Time point 2: Approximately 36-week gestation
Time point 3: 10-12 weeks postpartum (follow-up)

Eligibility
Key inclusion criteria
Pregnant women were eligible to participate in the study if they were: (a) aged 18 or older; (b) 20+ weeks gestation at onset of program; (c) had sufficient English and intellectual proficiency to understand and complete the questionnaires; (d) did not receive antenatal care from specialised clinics, irrespective of parity and ethnicity; (e) from Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women were not eligible to participate in the study if they were: (a) younger than 18-year old; (b) 20- weeks gestation or 26+ gestation at onset of program; (c) did not have sufficient English and intellectual proficiency to understand and complete the questionnaires; (d) received antenatal care from specialised clinics, irrespective of parity and ethnicity; (e) from Australia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It is an e-health feasibility study without a controlled group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The online 9-session mindfulness-based intervention study is a non-randomised feasibility study. Feasibility studies need a minimum of 12 participants as they only test the feasibility of an intervention. The study has 13 participants. Measurements of mindfulness, mental health, in particular depression, anxiety and stress, mother-foetus relationship, and interception were taken pre (20+ weeks gestation) and post-intervention (approximately 36 weeks gestation) through the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF; Bohlmeijer, et al., 2011), Postnatal Depression Scale (EPDS; Cox, et al., 1987), the Depression Anxiety Stress Scale-21 Short Form (DASS-21; Lovibond & Lovibond, 1995 ), the Maternal-Foetal Attachment Scale (MFAS; Cranley, 1981), and the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA; Mehling et al., 2012). Same measurements, excluding the mother-foetus relationship and including the mother-infant emotional availability, were taken 10-12 weeks postpartum through the same questionnaires. The mother-infant emotional availability was measured through the Emotional Availability Self-Report (EAS) (EA-SR; Vliegen, et al., 2005). Data was collected via a secure online survey platform called Qualtrics and the link to the platform and information about the study were provided on the study advertisement. Analysis of outcome data for the non-randomised trial involves One-Way Repeated Measures Analysis of Variance (ANOVA) to test for statistically significant differences between three related sample means at three separate points in time - baseline, post-intervention and postpartum mean scores.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/03/2022
Date of last participant enrolment
Anticipated
Actual
5/01/2023
Date of last data collection
Anticipated
Actual
7/01/2023
Sample size
Target
13
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 313660 0
University
Name [1] 313660 0
Bond University
Country [1] 313660 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Gold Coast, Queensland, 4229
Country
Australia
Secondary sponsor category [1] 315459 0
University
Name [1] 315459 0
Bond University
Address [1] 315459 0
Gold Coast, Queensland, 4229
Country [1] 315459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312827 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 312827 0
Bond University, Gold Coast, Queensland 4229
Ethics committee country [1] 312827 0
Australia
Date submitted for ethics approval [1] 312827 0
Approval date [1] 312827 0
10/01/2022
Ethics approval number [1] 312827 0
AS03534:

Summary
Brief summary
The primary purpose of this study was to test the hypothesis, through a e-health feasibility study (Study 2), that the Prenatal Mindfulness Relationship-Based (PMRB) program could enhance the mental health of pregnant and new mothers as measured by multiple dimensions of psychological health and the relationship with their infants during pregnancy and postpartum, with positive impacts on gestation, birth and infant outcomes as reported by the mothers in a Post-Birth Questionnaire. The study also aimed to provide further information, based on available literature, about the influence of maternal interoception (embodied awareness) on maternal mental health, in particular depression, anxiety, and stress, mindfulness, and mother-infant relationship during pregnancy and post-birth, in particular emotional availability, which can contribute to the development of mind-body approaches to pregnancy healthcare.This study addressed the following research questions (RQ): RQ1: Would participation in the PMRB program lead to higher levels of mindfulness,
better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline? RQ2: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth? RQ3: Open-ended - “How has the PMRB program supported (or not supported) you during pregnancy, labour and birth and the first postpartum trimester?” The specific hypothesis are: 1) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline; 2) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth; 3) The PMRB program would support women during their pregnancy, labour and birth, and the first postpartum trimester.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126058 0
Mrs Antonella Sansone-Southwooth
Address 126058 0
Bond University | Gold Coast, Queensland, 4229, Australia
Country 126058 0
Australia
Phone 126058 0
+61 755951111
Fax 126058 0
Email 126058 0
antonella.sansone-southwood@student.bond.edu.au
Contact person for public queries
Name 126059 0
Mrs Antonella Sansone-Southwood
Address 126059 0
Bond University, Gold Coast, Queensland, 4229, Australia
Country 126059 0
Australia
Phone 126059 0
+61 755951111
Fax 126059 0
Email 126059 0
antonella.sansone-southwood@student.bond.edu.au
Contact person for scientific queries
Name 126060 0
Mrs Antonella Sansone-Southwood
Address 126060 0
Bond University, Gold Coast, Queensland, 4229
Country 126060 0
Australia
Phone 126060 0
+61 755951111
Fax 126060 0
Email 126060 0
antonella.sansone-southwood@student.bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de identified data will be available
When will data be available (start and end dates)?
End of August/September 2023 when I expect the articles to be published and available for 5 years following main results publication
Available to whom?
De identified data will be available in a cloud share system such as OSF by signing in via Bond University
https://accounts.osf.io/login?service=https://osf.io/5shc3/
Available for what types of analyses?
The repeated ANOVA analysis
How or where can data be obtained?
A cloud store system will be available such as OSF above


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18929Study protocol  antonella.sansone-southwood@student.bond.edu.au In the cloud store system - most journals ask for ... [More Details] 385750-(Uploaded-30-04-2023-19-28-44)-Study-related document.docx
18964Informed consent form  antonella.sansone-southwood@student.bond.edu.au In the cloud store system - most journals ask for ... [More Details] 385750-(Uploaded-30-04-2023-15-51-21)-Study-related document.docx
18965Ethical approval  antonella.sansone-southwood@student.bond.edu.au In the cloud store system - most journals ask for ... [More Details] 385750-(Uploaded-30-04-2023-15-54-38)-Study-related document.pdf
18966Other  antonella.sansone-southwood@student.bond.edu.au Participant Information Sheet In the cloud store ... [More Details] 385750-(Uploaded-30-04-2023-15-58-14)-Study-related document.docx
18968Clinical study report  antonella.sansone-southwood@student.bond.edu.au In the cloud store system - most journals ask for ... [More Details]



Results publications and other study-related documents

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