Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000672954p
Ethics application status
Submitted, not yet approved
Date submitted
25/04/2020
Date registered
12/06/2020
Date last updated
12/06/2020
Date data sharing statement initially provided
12/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mums Minds Matter: A pilot randomized controlled trial comparing different types of online meditation training for promoting women's mental health in pregnancy
Scientific title
Mums Minds Matter: A three-arm pilot randomized controlled trial of Internet-based mindfulness, loving-kindness/compassion and relaxation training to support wellbeing in pregnancy
Secondary ID [1] 300535 0
None
Universal Trial Number (UTN)
U1111-1250-6808
Trial acronym
MMM
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 316245 0
Mental Wellbeing 317474 0
Condition category
Condition code
Public Health 314531 314531 0 0
Health promotion/education
Mental Health 314532 314532 0 0
Depression
Mental Health 314533 314533 0 0
Anxiety
Mental Health 315306 315306 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Online mindfulness meditation

- Participants will receive access to an online program that contains 8 mindfulness meditation practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length. Participants also receive written instructions for an "informal" mindfulness practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purposes of this study.
- Participants are encouraged to listen to the allocated meditation practice once per day
- Participants receive a text message once per week asking them to self-report adherence and barriers/facilitators to engagement with the program, as well as complete a brief battery of weekly measures.
- The meditation recordings are developed for the purposes of this study by registered psychologists with Masters-level training in clinical psychology and certification in Mindfulness- and Compassion-based interventions.
- Mindfulness recordings emphasise developing non-judgemental present-moment awareness
- All intervention activities are delivered on an individual basis, via the Internet
-Participants are part of the ORIGINS Project longitudinal birth cohort study. They are recruited from the ORIGINS study (at an antenatal clinic appointment) but undertake all intervention activities online and are invited to complete the practices wherever it suits them


2. Online loving-kindness and compassion meditation
- Participants will receive access to an online program that contains 8 loving-kindness/compassion meditation practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length. Participants also receive written instructions for an "informal" loving-kindness/compassion practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purposes of this study.
- Participants are encouraged to listen to the allocated meditation practice once per day
- Participants receive a text message once per week asking them to self-report adherence and barriers/facilitators to engagement with the program, as well as complete a brief battery of weekly measures.
- The meditation recordings are developed for the purposes of this study by registered psychologists with Masters-level training in clinical psychology and certification in Mindfulness- and Compassion-based interventions.
- Loving/Kindness and Compassion recordings emphasise intentional cultivation of feelings of goodwill and compassion towards self and others
- All intervention activities are delivered on an individual basis, via the Internet or text message (weekly messages only)
-Participants are part of the ORIGINS Project longitudinal birth cohort study. They are recruited from the ORIGINS study (at an antenatal clinic appointment) but undertake all intervention activities online and are invited to complete the practices wherever it suits them
Intervention code [1] 316838 0
Prevention
Comparator / control treatment
Online progressive muscle relaxation

- Participants will receive access to an online program that contains 8 progressive muscle relaxation (PMR) practices delivered over 8 weeks (1 per week). Practices are delivered as audio recordings, and are between 7-15 minutes in length (weekly practices are matched in length to the practices in the intervention conditions).. Participants also receive written instructions for an "informal" progressive muscle relaxation practice (1 per week) plus psychoeducational content (delivered via text/video, no more than 5 minutes duration per week). All content is developed for the purposes of this study.
- Participants are encouraged to listen to the allocated PMR practice once per day
- Participants receive a text message once per week asking them to self-report adherence and barriers/facilitators to engagement with the program, as well as complete a brief battery of weekly measures.
- The PMR recordings are developed by registered psychologists with Masters-level training in clinical psychology and certification in Mindfulness- and Compassion-based interventions.
- All intervention activities are delivered on an individual basis, via the Internet or text message
-Participants are part of the ORIGINS Project longitudinal birth cohort study. They are recruited from the ORIGINS study (at an antenatal clinic appointment) but undertake all intervention activities online and are invited to complete the practices wherever it suits them
Control group
Active

Outcomes
Primary outcome [1] 322854 0
Feasibility of RCT based on recruitment, randomization, retention, adherence and acceptability. Feasibility metrics will be assessed using the "A process for Decision-making after Pilot and feasibility Trials" framework, and the decision to proceed to a full scale RCT without amendment will be based on the following criteria::
Recruitment: greater than or equal to 50% of eligible participants consenting to participate in pilot study (measured by proportion of eligible ORIGINS participants enrolling in Mums Minds Matter)

Retention: greater than or equal to 50% of enrolled participants in each intervention arm "complete" the intervention (i.e. engage in all modules)

Adherence; greater than or equal to 50% of participants complete more than or equal to 50% daily practices

Acceptability Program satisfaction ratings demonstrate high satisfaction and acceptability of program (i.e. ratings of "agree" or "strongly agree" on indices of satisfaction and acceptability) for greater than or equal to 50% participants
Timepoint [1] 322854 0
8 weeks post baseline
Secondary outcome [1] 380068 0
Change in mental health scores on the Mental Health Continuum Short Form .
Timepoint [1] 380068 0
8 weeks post baseline
Secondary outcome [2] 380069 0
Change in perceived stress scores on the 10-item Perceived Stress Scale
Timepoint [2] 380069 0
8 weeks post baseline
Secondary outcome [3] 380072 0
Change in depression scores on the Edinburgh Postnatal Depression Scale
Timepoint [3] 380072 0
8 weeks post baseline
Secondary outcome [4] 382366 0
Change in mindfulness scores on the Mindful Attention and Awareness Scale
Timepoint [4] 382366 0
8 weeks post-baseline.
Secondary outcome [5] 382367 0
Change in self-compassion scores on the Self-Compassion Scale Short Form
Timepoint [5] 382367 0
8 weeks post-baseline
Secondary outcome [6] 382368 0
Change in Emotion Regulation Difficulties scores on the 16-item Difficulties in Emotion Regulation Scale
Timepoint [6] 382368 0
8 weeks post-baseline.
Secondary outcome [7] 382369 0
Change in Anxiety scores on the Generalized Anxiety Disorder 7-item scale
Timepoint [7] 382369 0
8 weeks post baseline
Secondary outcome [8] 382370 0
Change in Quality of Life Scores on the EQ-5D
Timepoint [8] 382370 0
8 weeks post-baseline

Eligibility
Key inclusion criteria
Pregnant (up to 30 weeks GA)
Enrolled in the ORIGINS Project Longitudinal Birth Cohort Study
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand English
No access to the Internet

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)
Concealed allocation using an automated electronic screening survey to determine eligibility and an automated randomisation process (via REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Stratification based on parity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics of participants will be reported to describe the sample. Descriptive statistics will be used to summarize quantitative data collected for each of the feasibility domains. While the purpose of the study is not hypothesis testing, we will calculate differences between the experimental groups and the control condition for the primary and secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2020
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16408 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 29953 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 304947 0
Other
Name [1] 304947 0
Telethon Kids Institute
Country [1] 304947 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
15 Hospital Avenue
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 305301 0
None
Name [1] 305301 0
Address [1] 305301 0
Country [1] 305301 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305358 0
Joondalup Health Campus - Human Research Ethics Committee
Ethics committee address [1] 305358 0
Research Ethics Dept, c/o CGU Building, PO Box 242, JOONDALUP WA 6027
Ethics committee country [1] 305358 0
Australia
Date submitted for ethics approval [1] 305358 0
30/05/2019
Approval date [1] 305358 0
Ethics approval number [1] 305358 0
1927

Summary
Brief summary
This project aims to pilot a protocol for a randomized controlled trial which will compare the effectiveness of two experimental conditions (online mindfulness training and online compassion and loving-kindness training) with an active control (online progressive muscle relaxation training) for improving maternal mental health (scores on the mental health continuum short form), symptoms of maternal distress (symptoms of stress, anxiety, and depression) during pregnancy. All intervention conditions will be delivered over 8 weeks and will be minimal-contact, meaning that participants will use an online program at home to practice mindfulness, loving-kindness/compassion, or the relaxation condition. Participants will also receive a weekly text message to ask them about their engagement with the program and ask them to complete a short weekly online measure battery (measures of affect, stress, and emotion regulation).

The aim of the pilot study is to assess the feasibility of the RCT protocol which compares the three conditions delivered online as a series of instructional material and brief daily practices. Feasibility will be assessed based on recruitment, randomization, retention, acceptability and adherence. Adverse events for all conditions will be monitored and compared. We also aim to explore the experiences of women in the trial by conducting interviews with randomly selected participants in each condition.. Finally, we will use data gathered to estimate standard deviation values for each outcome measure. This will be used to inform sample-size calculates for a full-scale RCT.

We aim to recruit 25 participants per treatment arm (75 participants in total). Participants will be eligible if they are over 18 years old, and are participants in The ORIGINS Project longitudinal birth cohort. Participants will be recruited from Joondalup Health Campus at their earliest antenatal visit.
Trial website
https://originsproject.telethonkids.org.au/current-studies/Mums-Minds-Matter
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100106 0
Dr Amy Finlay-Jones
Address 100106 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 100106 0
Australia
Phone 100106 0
+61 8 6319 1808
Fax 100106 0
Email 100106 0
[email protected]
Contact person for public queries
Name 100107 0
Dr Amy Finlay-Jones
Address 100107 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 100107 0
Australia
Phone 100107 0
+61 8 6319 1808
Fax 100107 0
Email 100107 0
[email protected]
Contact person for scientific queries
Name 100108 0
Dr Amy Finlay-Jones
Address 100108 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA 6009
Country 100108 0
Australia
Phone 100108 0
+61 8 6319 1808
Fax 100108 0
Email 100108 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
We do not yet have ethics approval for this.


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
No additional documents have been identified.