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A pilot study to test recruitment methods, feasibility and study procedures for a planned randomised controlled trial of the MindBabyBody program: an antenatal mindfulness intervention to reduce depression, stress and anxiety

A pilot study to test recruitment methods, feasibility and study procedures for a planned randomised controlled trial of the MindBabyBody program: an antenatal mindfulness intervention to reduce depression, stress and anxiety

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000742774
Acronym
MBB
Enrollment
52
Registered
2013-07-03
Start date
2012-10-31
Completion date
2013-06-19
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mindfulness interventions are emerging as a potentially promising intervention to reduce mental health problems in the perinatal period, however there is a need for more robust evidence supporting their efficacy. The current proposal outlines a pilot study with the primary aim of exploring feasibility issues to inform the development of a randomised-controlled trial of a mindfulness-based intervention in pregnancy. We propose to test and evaluate a range of recruitment strategies designed to maximise uptake of a program offered to women booked in to give birth at the Royal Women's Hospital. We aim to recruit around 45 women to this pilot study. Participants in the project will complete study questionnaires at three time-points: pre-intervention, post-intervention, and at a three months postpartum follow-up. Questionnaires will include standardised measures of depression, anxiety, stress, and mindfulness. The postnatal follow-up questionnaire will include items on maternal postnatal quality of life and child outcomes (cry-fuss-sleep behaviour). Analysis will focus on uptake via different recruitment methods and assess rates of ongoing participation, engagement, and acceptability of study instruments. The data collected in this study will be used to inform the development of a large scale randomised controlled trial evaluating a mindfulness-based group intervention in pregnancy for reducing perinatal anxiety and depression. In addition, the pilot study will support and develop collaborative links between staff at The Royal Women's Hospital and researchers in the Healthy Mothers, Healthy Families group at the Murdoch Childrens Research Institute.

Interventions

The MindBabyBody program comprises a 6-session mindfulness-based group therapy program based on Mindfulness-Based Cognitive Therapy (MBCT) and developed by Dr Krisinte Mercuri specifically for use in pregnancy. Participants are introduced to the mindfulness approach, and mindfulness strategies including formal and informal meditation practices and mindful movement. This program is currently being offered at The Royal Women's Hospital as part of their clinical services, specifically targeting wom

The MindBabyBody program comprises a 6-session mindfulness-based group therapy program based on Mindfulness-Based Cognitive Therapy (MBCT) and developed by Dr Krisinte Mercuri specifically for use in pregnancy. Participants are introduced to the mindfulness approach, and mindfulness strategies including formal and informal meditation practices and mindful movement. This program is currently being offered at The Royal Women's Hospital as part of their clinical services, specifically targeting women with current or previous mental health concerns. The intervention in the pilot study will be promoted to all women attending the antenatal clinic as a program which is aimed at managing stress and mood during pregnancy and the postnatal period. Each session runs for approximately 2 hours, and occurs weekly for six weeks. Each session involves a period of formal meditation, a discussion of the participant experiences of mindfulness practice, a weekly topic for discussion (focused on features of mindfulness relevant to pregnancy and motherhood) and some simple mindful yoga stretches. Each week suggestions are given for home practice with repetition emphasised as a significant reinforcer of new skills. In the post-program questionnaire, participants who have completed the MindBabyBody program will be asked questions about the level of formal and informal practice they have completed throughout the program. Attendance records will also be kept.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Greater than 10 weeks gestation Booked in to give birth at the Royal Women’s Hospital Aged 18– 50 years

Exclusion criteria

Greater than 34 weeks gestation Current substance abuse Insufficient fluency in English to participate in mindfulness sessions and/or complete written questionnaires in English Serious current mental morbidity such as severe suicidal ideation.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026