Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001581752
Ethics application status
Approved
Date submitted
7/12/2022
Date registered
22/12/2022
Date last updated
1/03/2023
Date data sharing statement initially provided
22/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention for maternal mental health in the peripartum: A randomised controlled trial
Scientific title
Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention for maternal mental health in the peripartum: A randomised controlled trial
Secondary ID [1] 308576 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal Mental Health 328438 0
Condition category
Condition code
Mental Health 325464 325464 0 0
Anxiety
Mental Health 325465 325465 0 0
Depression
Mental Health 325466 325466 0 0
Other mental health disorders
Mental Health 325467 325467 0 0
Psychosis and personality disorders
Mental Health 325468 325468 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Mindfulness App will be available to the intervention group. The Mater Parent Lounge app is a perinatal mindfulness-based app, co-designed by women with a lived experience of perinatal mental illness, and clinicians with expertise in mindfulness. The content on the app will consist of 40 mindfulness podcasts, tailored to different stages in the pre- (second trimester) and post-partum period (6 months after birth). Women will therefore take part in the study from 16 weeks gestation to 6 months postpartum (approximately 11 months in total, dependent on which gestation week participants' give birth).
The content of the app has been co-designed by a working group of clinicians, peer workers, and consumer advocates (women who have previous lived experiences of perinatal mental health issues). The podcasts brief (5-10 minute) videos that take women through a range of mindfulness exercises, such as breathing exercises, visualisation, body scanning, guided interaction with baby, guided meditation and other grounding techniques. Acceptability of the content was determined by all members of the co-design working group over a series of meetings.
The app will notify women with suggestions of appropriate (pregnancy-period specific) podcasts on a regular basis. Women may choose to watch the suggested podcasts, or search for other podcasts when they wish to utilise them. Women will be free to use these podcasts as often as they wish for the study period, and beyond. For the study period, they will be asked to utilise the app a minimum of once a week to determine its benefit. Click analytics will be used to measure the frequency of app use, and to determine which podcasts are the most used. Daily 'mood' data will also be collected from the app using a five point faces scale (happy face to sad face).
Intervention code [1] 325021 0
Treatment: Devices
Comparator / control treatment
Usual care. This includes access to mental health clinicians (psychiatrists, psychologists, social workers, mental health nurses, and occupational therapists), but with no access to the Mindfulness App.
Control group
Active

Outcomes
Primary outcome [1] 333313 0
Psychological distress (measured using the Edinburgh Postnatal Depression Scale).
Timepoint [1] 333313 0
Baseline (16 weeks gestation), Time 2 (28 weeks gestation), Time 3 (3 months postpartum), Time 4 (6 months postpartum - primary endpoint).
Secondary outcome [1] 416591 0
Satisfaction with the mindfulness app, measured using a Satisfaction Survey. This is a study- survey developed specifically for the purposes of this research project.
Timepoint [1] 416591 0
Time 3 (3 months postpartum)
Secondary outcome [2] 416593 0
Cost-efficiency (cost benefits) of the intervention, assessed using Quality-Adjusted Life Years (QALYs - derived from the PROMIS Global-10 quality of life survey).
Timepoint [2] 416593 0
Baseline (16 weeks gestation), Time 2 (28 weeks gestation), Time 3 (3 months postpartum), Time 4 (6 months postpartum).
Secondary outcome [3] 416594 0
Mother-infant bonding (measured using the Mother-to-infant bonding scale).
Timepoint [3] 416594 0
Time 3 (3 months postpartum), Time 4 (6 months postpartum).
Secondary outcome [4] 416744 0
App utilisation. Click analytics will be used to determine the frequency to which the app was used, and which podcasts were listed to most frequently.
Timepoint [4] 416744 0
This data will not be collected at a specific timepoint, but will be looked at periodically during the study period by researchers.
Secondary outcome [5] 417045 0
App satisfaction and feedback
App satisfaction and participant feedback will be collected in focus group interviews.
A portion of randomly selected intervention participants will be sent an invitation to participate in a focus group. Approximately 15 women will be recruited for focus group interviews, which will be conducted in groups of 6-8. They will be facilitated by a member of the research team with experience in qualitative interviewing.
The interviews will be conducted at the Mater hospital. Women will receive free parking and will be compensated with a $50 voucher for their time.
Focus group interviews will be semi-structured (based on an interview question guide), and will be approximately 45 - 60 minutes in length. They will be audiotaped and then de-identified and transcribed by a professional, third party transcription service.
Timepoint [5] 417045 0
Focus group interviews will be conducted at the conclusion of the study.

Eligibility
Key inclusion criteria
Women who are attending either the public or private maternity clinics at Mater Mothers Hospital in South Brisbane with English Proficiency
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are unable to access a smart device to complete surveys; women who have already used the Mater Parent Lounge Mindfulness App; women who are unable to understand English well enough to use the App; women who are unable to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using computer randomization software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analyses will be conducted according to the intention-to-treat principle. Descriptive statistics (mean/standard deviation, median/range, proportion/percentage) will be used to describe participants’ characteristics. Normality testing will precede inferential statistical tests of continuous outcomes, such as questionnaire scores. Continuous outcomes between timepoints will be evaluated using repeated measures analysis of variance, or Friedman test for normally and non-normally distributed data respectively. Statistical test results with a p-value<0.05 will be considered statistically significant. Subsequent post-hoc testing will be conducted to determine which timepoints significantly differ. Confounders (e.g. age, age of baby, gender of baby) will be accounted for in a regression model if appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
3/07/2023
Actual
Date of last data collection
Anticipated
24/07/2023
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23689 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 23690 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 39125 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312824 0
Hospital
Name [1] 312824 0
Betty McGrath Seeding Grant, Mater Misericordiae
Country [1] 312824 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae
Address
537 Stanley St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 314466 0
Other Collaborative groups
Name [1] 314466 0
Mater Research
Address [1] 314466 0
537 Stanley St, South Brisbane QLD 4101
Country [1] 314466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312103 0
Mater Misericordiae
Ethics committee address [1] 312103 0
Ethics committee country [1] 312103 0
Australia
Date submitted for ethics approval [1] 312103 0
15/08/2022
Approval date [1] 312103 0
17/10/2022
Ethics approval number [1] 312103 0
83589

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123486 0
Dr Grace Branjerdporn
Address 123486 0
Mater Misericordiae
Level 5, 41 Annerley Road Campus, South Brisbane, Qld 4101
Country 123486 0
Australia
Phone 123486 0
+61 408141234
Fax 123486 0
Email 123486 0
[email protected]
Contact person for public queries
Name 123487 0
Grace Branjerdporn
Address 123487 0
Mater Misericordiae
Level 5, 41 Annerley Road Campus, South Brisbane, Qld 4101
Country 123487 0
Australia
Phone 123487 0
+61 408141234
Fax 123487 0
Email 123487 0
[email protected]
Contact person for scientific queries
Name 123488 0
Grace Branjerdporn
Address 123488 0
Mater Misericordiae
Level 5, 41 Annerley Road Campus, South Brisbane, Qld 4101
Country 123488 0
Australia
Phone 123488 0
+61 408141234
Fax 123488 0
Email 123488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the data, and patient conditions, only aggregate data will be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial.2023https://dx.doi.org/10.1186/s13063-023-07746-7
N.B. These documents automatically identified may not have been verified by the study sponsor.