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Trial registered on ANZCTR


Registration number
ACTRN12613000742774
Ethics application status
Approved
Date submitted
3/07/2013
Date registered
3/07/2013
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Date results information initially provided
7/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 282782 0
Nil
Universal Trial Number (UTN)
Trial acronym
MBB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression, anxiety, and stress 289545 0
Condition category
Condition code
Mental Health 289869 289869 0 0
Depression
Mental Health 289870 289870 0 0
Anxiety
Reproductive Health and Childbirth 289872 289872 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287457 0
Prevention
Intervention code [2] 287458 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive care as usual through the Royal Women's Hospital. The main aim of the pilot study is to test different recruitment strategies, including the universal recruitment of women into a randomised controlled trial. The use of a non-treatment control group is important in determining the acceptability of recruitment to a randomised controlled trial for potential participants.
Control group
Active

Outcomes
Primary outcome [1] 289930 0
Recruitment method.
As a pilot study, we are focused on assessing feasibility issues. Each participant enrolled in the study will be asked the two following questions:
1) How did you first hear about the study, and
2) When did you decide to enrol in the MindBabyBody pilot study.
Response options for these questions are:
- I read the information sheet provided in my booking-in pack
- I received information about the study at the Childbirth Education classes
- I received information about the study at a physiotherapy class ?
- I was given information about the study by a researcher in the Royal Women’s Hospital antenatal booking clinic
- My midwife recommended the program to me

We are using two questions because of the possibility that women maybe exposed to more than one recruitment method.
Timepoint [1] 289930 0
Baseline
Primary outcome [2] 289931 0
Participant characteristics (such as age, current gestation, parity, marital status, education level, employment status).
As a pilot study, we are focused on feasibility issues, and we are interested in participant characteristics according to the method of recruitment. These will be assessed using a questionnaire specifically designed for this pilot study.
Timepoint [2] 289931 0
Baseline
Primary outcome [3] 289932 0
Participant retention.
As a pilot study, we are focused on feasibility issues, such as length of study measures, and the ability to retain participants in a non-treatment control group.
Participant retention will be assessed by the number of questionnaires returned for control and intervention groups.
Timepoint [3] 289932 0
Baseline, 8-weeks post baseline, and 3 months postpartum.
Secondary outcome [1] 303591 0
Maternal depression assessed via the Center for Epidemiologic Studies Depression Scale
Timepoint [1] 303591 0
Baseline, 8-weeks post baseline, and 3 months postpartum.
Secondary outcome [2] 303592 0
Maternal anxiety measured via the State-Trait Anxiety Scale.
Timepoint [2] 303592 0
Baseline, 8-weeks post baseline and at 3 months postpartum.
Secondary outcome [3] 303593 0
Maternal stress measured via the Perceived Stress Scale.
Timepoint [3] 303593 0
Baseline, 8-weeks post baseline, and at 3 months postpartum
Secondary outcome [4] 303604 0
Maternal Psychological Distress, measured by the Depression, Anxiety and Stress Scale (DASS).
We will also compare how the DASS subscales perform compared to the three separate measures assessing depression, anxiety and stress in regards to treatment outcome.
Timepoint [4] 303604 0
Baseline, 8-weeks post baseline, and at 3 months postpartum.

Eligibility
Key inclusion criteria
Greater than 10 weeks gestation
Booked in to give birth at the Royal Women’s Hospital
Aged 18– 50 years
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants in the RCT were allocated to the intervention (i.e. MindBabyBody program) or care as usual groups through the use of sealed sequential envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1201 0
The Royal Women's Hospital - Parkville

Funding & Sponsors
Funding source category [1] 287553 0
Other
Name [1] 287553 0
Murdoch Childrens Research Institute
Address [1] 287553 0
Royal Childrens Hospital
Flemington Road
Parkville, VIC, 3052
Country [1] 287553 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Royal Children's Hospital
Flemington Road
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 286303 0
Hospital
Name [1] 286303 0
Royal Women's Hospital
Address [1] 286303 0
Flemington Road
Parkville, VIC, 3052
Country [1] 286303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307467 0
Royal Children's Hospital
Ethics committee address [1] 307467 0
50 Flemington Road, Parkville VIC 3052
Ethics committee country [1] 307467 0
Australia
Date submitted for ethics approval [1] 307467 0
Approval date [1] 307467 0
24/09/2012
Ethics approval number [1] 307467 0
32200
Ethics committee name [2] 307468 0
Royal Women's Hospital
Ethics committee address [2] 307468 0
20 Flemington Rd, Parkville VIC 3052
Ethics committee country [2] 307468 0
Australia
Date submitted for ethics approval [2] 307468 0
Approval date [2] 307468 0
27/08/2012
Ethics approval number [2] 307468 0
12/23

Summary
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.
Trial website
Trial related presentations / publications
Woolhouse H, Mercuri K, Judd F, Brown SJ. Antenatal mindfulness intervention to reduce depression, anxiety and stress: a pilot randomisided trial of the MindBabyBody program in an Australian tertiary maternity hospital. BMC Pregnancy and Childbirth 2014 Oct 25;14(1):369.
Public notes

Contacts
Principal investigator
Name 41218 0
Dr Hannah Woolhouse
Address 41218 0
Healthy Mothers Healthy Families
Murdoch Childrens Research Institute
WL5 Royal Children's Hospital
Flemington Road
Parkville, VIC, 3052
Country 41218 0
Australia
Phone 41218 0
+613 9936 6619
Fax 41218 0
Email 41218 0
hannah.woolhouse@mcri.edu.au
Contact person for public queries
Name 41219 0
Dr Hannah Woolhouse
Address 41219 0
Healthy Mothers Healthy Families
Murdoch Childrens Research Institute
WL5 Royal Children's Hospital
Flemington Road
Parkville, VIC, 3052
Country 41219 0
Australia
Phone 41219 0
+613 9936 6619
Fax 41219 0
Email 41219 0
hannah.woolhouse@mcri.edu.au
Contact person for scientific queries
Name 41220 0
Dr Hannah Woolhouse
Address 41220 0
Healthy Mothers Healthy Families
Murdoch Childrens Research Institute
WL5 Royal Children's Hospital
Flemington Road
Parkville, VIC, 3052
Country 41220 0
Australia
Phone 41220 0
+613 9936 6619
Fax 41220 0
Email 41220 0
hannah.woolhouse@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 9984 0
Hannah Woolhouse, Kristine Mercuri, Fiona Judd, Stephanie Brown. Antenatal mindfulness intervention to reduce depression, anxiety and stress: A pilot randomised controlled trial. BMC Pregnancy Childbirth, 2014;14:369.
Attachments [1] 9984 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary