Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000509965
Ethics application status
Approved
Date submitted
28/02/2020
Date registered
24/04/2020
Date last updated
24/04/2020
Date data sharing statement initially provided
24/04/2020
Date results information initially provided
24/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of a brief online self-compassion intervention for mothers of infants
Scientific title
Randomised controlled trial of a brief online self-compassion intervention for mothers of infants
Secondary ID [1] 300267 0
Nil
Universal Trial Number (UTN)
U1111-1246-5152
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal mental health 315845 0
Condition category
Condition code
Mental Health 314127 314127 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 315024 315024 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants completed an online self-report survey on Qualtrics. They were asked to provide their email address and mobile phone number at the end of the first (Time 1) set of questionnaires. This enabled us to send an SMS message and email (containing the link to the Time 2 questionnaire) to remind all participants to complete the Time 2 questionnaire 8 weeks after they had completed the Time 1 questionnaire. It also allowed us to send SMS messages (as part of the intervention) to prompt intervention group participants to engage in the self-compassion intervention. Intervention group participants received up to 10 SMS messages over the course of the experiment.

The online intervention (delivered to the intervention group only) comprised (i) a brief web-based informational video, that began with a psychoeducation component on compassion and its relevance to mothers of infants (from birth to 24 months), followed by simple strategies to prompt self-compassion in daily life; (ii) an audio-guided self-compassion meditation, which women were encouraged to listen to and use to guide their own self-compassion meditation practice for short periods (e.g. 2-5 minutes) each day for the next month; and (iii) a simple tip sheet summarising key points that was also made available to participants to download and print. The accompanying weekly SMS prompts were each based on the tips from this tip sheet.

Intervention participants were encouraged to participate in the self-compassion meditation through the website and SMS reminders. Intervention participants' use of the resources was monitored through SMS reminders, and self-report at the follow-up survey (participants were asked to elect the frequency with which they accessed the intervention resources).
Intervention code [1] 316994 0
Behaviour
Intervention code [2] 317209 0
Treatment: Other
Comparator / control treatment
The control group were a 'care as usual' group, that is, no active treatment or intervention was made available to these participants. Following the completion of the Time 2 questionnaire, all control participants were offered access to the online intervention resources through a link emailed to them.
Control group
Active

Outcomes
Primary outcome [1] 323051 0
Change in scores on The Compassionate Engagement and Action Scales - the Self-Compassion and Compassion from Others Scales
Timepoint [1] 323051 0
T2 (8 weeks post-T1 survey)
Primary outcome [2] 323052 0
Change in scores on The Fears of Compassion Scales - the Self-Compassion and Compassion from Others Scales
Timepoint [2] 323052 0
T2 (8 weeks post-T1 survey)
Primary outcome [3] 323053 0
Change in scores on The Maternal Breastfeeding Evaluation Scale
Timepoint [3] 323053 0
T2 (8 weeks post-T1 survey)
Secondary outcome [1] 380617 0
Change in scores on The Depression, Anxiety, and Stress Scales (21 item version)
Timepoint [1] 380617 0
T2 (8 weeks post-T1 survey)
Secondary outcome [2] 380618 0
Change in scores on The Impact of Event Scale-Revised
Timepoint [2] 380618 0
T2 (8 weeks post-T1 survey)
Secondary outcome [3] 380619 0
Change in scores on The Acceptance and Action Questionnaire (AAQ-II)
Timepoint [3] 380619 0
T2 (8 weeks post-T1 survey)

Eligibility
Key inclusion criteria
Women aged 18+ years who had given birth to a child in the past 2 years and resided in Australia or New Zealand.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who were younger than 18 years, who had given birth to a child more than 2 years ago, or who resided outside of Australia and new Zealand.

Study design
Purpose of the study
Educational / counselling / training
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)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In line with previous research indicating small effect sizes (d = .08-.22) of a brief online self-compassion intervention on breastfeeding satisfaction and psychological outcomes, an a priori power analysis (power = 0.8, a = .05) estimated a sample size of at least 218 participants. Allowing for attrition, a sample size of 250 was deemed sufficient.

Statistical analysis comprised descriptive statistics (to measure demographic data and intervention participants' use of the intervention resources), ANCOVA models to explore pre-post group differences in primary and secondary outcomes, and Pearson correlational analyses to explore relationships between outcome variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
17/07/2019
Date of last data collection
Anticipated
Actual
10/09/2019
Sample size
Target
250
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22396 0
New Zealand
State/province [1] 22396 0

Funding & Sponsors
Funding source category [1] 305090 0
Self funded/Unfunded
Name [1] 305090 0
Country [1] 305090 0
Primary sponsor type
University
Name
The University of Queensland, Parenting and Family Support Centre
Address
19/13 Upland Rd, St Lucia QLD 4067
Country
Australia
Secondary sponsor category [1] 304999 0
None
Name [1] 304999 0
Address [1] 304999 0
Country [1] 304999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305110 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 305110 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane, QLD, 4072
Ethics committee country [1] 305110 0
Australia
Date submitted for ethics approval [1] 305110 0
12/02/2019
Approval date [1] 305110 0
18/03/2019
Ethics approval number [1] 305110 0
2019000296

Summary
Brief summary
The purpose of this study was to discover better ways to care for the psychological wellbeing of mothers, particularly in supporting mothers to cope with difficult thoughts and feelings about their childbirth and early feeding experiences. Participation in the study involved the completion of an online survey asking questions about your own coping, childbirth, and feeding experiences. After completing this survey, participants had a 50/50 chance of being given immediate access to a brief information package intended to support their wellbeing. The package included information on self-compassion, a compassion exercise, a tip sheet, and SMS reminders. Participants were randomised (like the flip of a coin) to either receive this information package straight away or after an 8-week waiting period. This allowed us to identify whether or not the package was helpful to mothers who use it. We anticipated that those who received access to the online self-compassion intervention would report greater wellbeing in a number of areas at an 8-week follow-up period.
Trial website
https://exp.psy.uq.edu.au/mothercare/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99298 0
Ms Georgina Lennard
Address 99298 0
Parenting and Family Support Centre
UQ School of Psychology
13 Upland Road, St Lucia
The University of Queensland
Brisbane Qld 4072 Australia
Country 99298 0
Australia
Phone 99298 0
+61733461202
Fax 99298 0
Email 99298 0
[email protected]
Contact person for public queries
Name 99299 0
Dr Amy Mitchell
Address 99299 0
Parenting and Family Support Centre
UQ School of Psychology
13 Upland Road, St Lucia
The University of Queensland
Brisbane Qld 4072 Australia
Country 99299 0
Australia
Phone 99299 0
+61733461202
Fax 99299 0
Email 99299 0
[email protected]
Contact person for scientific queries
Name 99300 0
Dr Amy Mitchell
Address 99300 0
Parenting and Family Support Centre
UQ School of Psychology
13 Upland Road, St Lucia
The University of Queensland
Brisbane Qld 4072 Australia
Country 99300 0
Australia
Phone 99300 0
+61733461202
Fax 99300 0
Email 99300 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


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.