Study setting {9}
The trial will be a single-site study conducted at the largest maternity hospital in Australia. The site, located in Brisbane, Queensland, manages an average of 10,000 births annually. This hospital provides a large range of antenatal care to women, including standard care by midwives to low-risk women, and specialty clinical care to high-risk women. A wide range of maternity models of care are available at the hospital, including specialty services for women who may be affected by substance use disorders, women with special needs, and refugee clinics. Participants for this study will be recruited from women who are attending both the public and private maternity clinics at this hospital.
Eligibility criteria {10}
All women attending the public or private maternity clinics at Mater Misericordiae in Brisbane, will be recruited into the study. Women must be 18 years or older, and be proficient in English, as that is the only language the first iteration of the app will be created in. Women must also own a smartphone device that is capable of downloading and running the Mater Parent Lounge app.
Who will take informed consent? {26a}
Eligible women will be sent a copy of the research information sheet and consent form via an SMS message. This will include a tick box where women may select to either participate or opt out of the study. Failure to respond to the initial message will trigger a follow-up phone call by a research team member who will explain the study and request that the women select an option via the SMS-delivered consent form.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Additional demographic and medical history data will be extracted from medical records. No sensitive or identifying data will be collected or stored on the App. De-identified survey data is collected via a university-run software program and stored on the hospital computer network.
Interventions
Explanation for the choice of comparators {6b}
The study compares the outcomes of an intervention group to a passive control group that undertakes usual care. A weight list control or stepped wedge design would be inappropriate for this study as the app is tailored to specific timeframes within the pregnancy. However, all women will be given access to the app once they have completed the study.
Intervention description {11a}
The Mater Parent Lounge app is a perinatal mindfulness-based app, co-designed by women with lived experience of perinatal mental illness, and clinicians with expertise in mindfulness and perinatal mental health. The content of 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). The podcasts will also be available for women to listen to on the Mater Mothers website.
Criteria for discontinuing or modifying allocated interventions {11b}
Participants will be free to withdraw from the study at any time. Women who appear in distress will be flagged by the research team, removed from the study, and offered additional support. To ensure the validity of results, all data collected from participants up to the point of withdrawal will be included in the analysis, which will be conducted according to the intention-to-treat principle.
Strategies to improve adherence to interventions {11c}
In order to improve adherence to the intervention requirements, and to increase the completion of assessments, all surveys and study information will be sent directly to participants’ smartphone devices. Participants will receive weekly SMS messages with reminders and links to the podcasts included on the App. Surveys will be sent to participants via SMS at each of the assessment time-points. Participants will be sent reminder messages if they do not complete the surveys within a set time period.
Relevant concomitant care permitted or prohibited during the trial {11d}
Participants will continue to receive their routine medical care throughout the study period, regardless of being randomised to the intervention or control arm.
Provisions for post-trial care {30}
The data collected in this study is not expected to cause significant distress or discomfort to participants. However, in the event that participants experience distress in the course of this study, the participant information sheet will provide participants with information for support services they can contact. This will include Beyond Blue, Lifeline, and the research team. In addition, participants who score highly on the EPDS scale, or noted on this scale that they have thought of self-harm, will be flagged by the research team, and further support will be offered.
Outcomes {12}
Postnatal depression will be the primary outcome of the study. Secondary outcomes will include mother-infant bonding, quality of life, cost-effectiveness of the intervention, and participant satisfaction with the app (see Figure 1). The study will also use click analytics to determine the frequency of app use. Demographic data and medical health information will be extracted from medical records for the purposes of inferential statistical analyses. Changes from baseline will be assessed for all health-related, repeated surveys. Measures will be analysed in aggregate form.
Participant timeline {13}
Sample size {14}
The necessary sample size was calculated using the public access software G*Power 3.1.9.7 for Windows [20]. The sample size calculation was determined for repeated measures analysis of variance (ANOVA), to detect a small treatment effect (f = 0.15) with 80% power and an error level probability of 0.05. This generated a sample size of 220. To allow for an attrition rate of 40%, the study will aim to recruit a minimum of 360 participants.
Recruitment {15}
The study will recruit women for up to three months, or until the sample size is achieved. The study site manages the treatment of over 800 women per month. Given the sample requirement is less than half this amount, we anticipate achieving full recruitment within two months.
Assignment of interventions: allocation
Sequence generation {16a}
Participants will be randomly allocated using computer randomization software. A permuted block randomization technique will be conducted to ensure assignment of participants will be even across the two groups.
Concealment mechanism {16b}
On-site, password-protected computer system.
Implementation {16c}
A research assistant will oversee the recruitment and randomization of participants. Participant information and consent SMS messages will be sent via the survey software. Follow-up phone calls will be made by the research assistant.
Assignment of interventions: Blinding
Who will be blinded {17a}
Care providers will not be aware of the assignment status of participants. Trial participants will not be blinded to their group allocation status. Research team members in charge of data analysis will be blinded to participant identities.
Procedure for unblinding if needed {17b}
All participant responses will be identified with a numerical pseudonym. A coding key will be kept separate to responses in a password protected file on the private hospital computer network. Should it become necessary, this coding key can be accessed to identify participants.
Data collection and management
Plans for assessment and collection of outcomes {18a}
Data will be collected through REDCap surveys, via focus group interviews, from online medical databases, or via the app. All surveys will be sent to, and completed by, participants via SMS sent directly to their phone, or the Mater Mother’s Lounge App.
The Edinburgh Postnatal Depression Scale (EPDS)
The EPDSis a 10-item questionnaire designed to screen women for symptoms of depression in the postnatal period [21]. Women completing the EPDS are asked to rate the option that best describes how they have felt in the past seven days in response to a number of statements (e.g. “I have blamed myself unnecessarily when things went wrong.”). Items are scored on a 4-point scale, with response scores ranging from 0 to 3. Item scores are summed to produce a total score. Scores ranging from 0 to 9 indicate low levels of distress, scores from 10 to 12 indicate presence of distress, and scores above 13 suggest high presence of depressive symptoms. A minimum four point change in scores across timepoints is necessary to be deemed clinically significant. The EPDS has been validated for use in both a prenatal and postnatal population [21, 22]. Women who score one, two, or three on item 10 (“The thought of harming myself has occurred to me”) will be addressed with further enquiry and support if necessary.
Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS Global-10)
The PROMIS Global-10is a 10-item questionnaire measuring quality of life through a range of domains, including mental health, physical health, satisfaction with social relationships, and engagement with daily activities [23]. The first nine questions on the scale are rated on a five-point Likert scale. Questions one to six are rated from “poor” (1) to “excellent” (5); question seven is rated from “not at all” (1) to “completely”; question eight is rated from “always” (1) to “never” (5); and question nine is rated from “very severe” (1) to “very mild” (5). Question ten is rated on a ten-point scale, asking participants to rate pain on a scale of one (“no pain”) to ten (“worst pain imaginable”). When scoring, scores on question ten are converted onto a five-point scale using the table provided in the scoring manual. Participants’ scores on this scale are summed to produce a raw total score. Raw scores on are converted into t-scores for interpretation against a standardized average score. A score above 50 indicates higher than average quality of life, whilst a score below 50 indicates lower than average quality of life.
Mother-to-Infant Bonding Scale
The Mother-to-Infant Bonding Scale is an 8-item questionnaire, which asks participants to rate their feelings about their child, to assess level of bonding [24]. The scale presents participants with eight adjectives (e.g. loving, resentful, disappointed). Participants score how often they feel these adjectives about their child within the first few weeks. Items are scored from 0 to 3 (0 = “not at all”, 1 = “a little”, 2 = “a lot”, 3 = “very much”). Items that indicate positive emotions about the mother’s child are reverse scored (i.e., 0 = “very much”, 3 = “not at all”). A higher total score on this scale indicates lower mother-infant bonding.
App Satisfaction
A study-specific, satisfaction survey has been developed for the purpose of evaluating satisfaction with the Mater Parent Lounge App. This survey is a 12-item questionnaire co-designed by clinicians and consumers, to assess women’s perceptions and opinions of the mindfulness intervention. Questions such as “how helpful did you find the Mater Parent Lounge App” and “Mater Parent Lounge improved my bonding with my baby” will be rated on 5- or 6- point Likert scales. This survey will be given to women in the intervention group.
A randomly selected portion of intervention participants (n = 10) will be invited to attend a focus group interview at the completion of the study. Semi-structured focus group interviews will be conducted in English, with no interpreter service available. An external facilitator who is experienced in conducting focus group interviews, will be sought to facilitate these focus groups. Three primary questions will be asked during the focus group interviews, with prompt questions available to assist in guiding the interview if required:
i. What did you like about the Mater Parent Lounge app?
ii. What did you dislike about the Mater Parent Lounge app?
iii. What would you change about the Mater Parent Lounge app?
Click Analytics
Click Analytics data will be obtained through the Mater Parent Lounge app to measure the frequency the app is used, how long the app is used for, and which podcasts are listened to most frequently. The App will also collect ‘mood’ data at each use of the app. This will be presented on the app as a 5-point scale in the format of happy to sad faces. No other data will be collected on the app.
Plans to promote participant retention and complete follow-up {18b}
Participants will be entered into a draw to win one of ten $100 supermarket vouchers on completion of the study. Intervention participants who agree to participate in the focus group interview to give feedback on the app will receive a $50 supermarket voucher.
Data management {19}
All data will be collected via survey software and stored on password protected folders on the private Mater computer network. Email addresses, for the purpose of survey distribution and matching, will be the only identifying data collected. All surveys will be de-identified and stored in a password-protected, cloud-based server in Australia, only accessible by the participating hospital. Paper records will be stored onsite in locked files, within locked cupboards. Both of these data storage sites will only be accessible by the research team. No sensitive or identifying data (including email addresses) will be collected by, or stored on, the app.
All data will be kept for a minimum of 5 years, as per NHMRC guidelines, but may be stored longer in a de-identifiable format to be used as comparative data for future projects. When data is no longer required, it will be anonymously and privately destroyed in a shredder, or deleted from the network.
Confidentiality {27}
Confidentiality will be assured with the use of numerical pseudonyms. No identifying information will be stored with any participant information or responses. All participants will be contacted by an external research assistant. Researchers with clinical roles or other positions within the hospital will not have any direct contact with potential or consenting participants.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
NA – no biological or physical specimens will be collected for this research.
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
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.
Interim analyses {21b}
Interim analyses will be conducted once 50% of the sample has completed the first time point and all four timepoints. These analyses will comprise of descriptive and correlational analyses to identify discrepancies in data collection methods, to highlight outliers and other errors, and to give an indication of findings.
Methods for additional analyses (e.g. subgroup analyses) {20b}
No additional analyses are planned. Subgroup analyses based on a stratified sample (i.e. between medical or psychiatric status, or different demographic criteria) may be considered depending on the size and composition of the final sample.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
All data will be analysed using an intention-to-treat study design, regardless of protocol adherence. Missing survey data will be handled as per the instructions in the scoring manual for each individual survey.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
De-identifiable participant data will be stored in the University of Queensland data repository (UQRDM).
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
The trial steering committee will consist of the Principal Investigator and all Co-Investigators: including the Medical Director, Nursing Director, Mental Health and Perinatal Health clinicians, Data analyst, and a consumer advocate.
Composition of the data monitoring committee, its role and reporting structure {21a}
The data will be monitored regularly by the research team, who will meet quarterly to monitor the progress of the study. Access to the data will be monitored by a nominated data custodian.
Adverse event reporting and harms {22}
All women will remain under the care of their usual treating doctors and maternity care clinicians, who will assist the women should any distress or discomfort arise. Participants will also be encouraged to inform the research team or contact one of the support service numbers listed in the information sheet, should they experience any physical or mental distress or harm for any reason while they are taking part in the research study.
Frequency and plans for auditing trial conduct {23}
The Project Steering Committee and research team will meet every three months to review the progress and conduct of the trial. Annual reports will be submitted to the funding body.
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Protocol amendments will first be submitted to the Mater Human Research Ethics Committee for approval. If any changes are made may in any way affect participants’ participation activities, involvement, or consent processes, participants will be informed of these changes by a member of the research team by email or phone.
Dissemination plans {31a}
The authors will disseminate the results of the study at conferences and by publication in peer-reviewed journals.