Are smartphone applications delivering mindfulness-based meditation interventions effective in enhancing mental well-being among pregnant and postpartum women, and what are its effects on neonatal health outcomes?

Study Setting: The study will be conducted in maternal hospitals and antenatal clinics, where eligible participants will be recruited during their routine antenatal visits. Following recruitment and baseline data collection, participants will continue the intervention independently at home, accessing it through a mobile application developed specifically for this study.

Method of Randomization: A simple randomization method will be employed. Every other participant who consents to participate will be allocated to the experimental (intervention) group, with the remaining participants allocated to the waitlisted control group. Unit of Randomization: The unit of randomization will be the individual pregnant woman. Method of Sequence Generation: Randomization will follow a manual allocation sequence, where every other eligible and consenting participant will be assigned to the experimental group as they are enrolled. Method of Allocation Concealment: There will be no allocation concealment in this study. Participants will be fully informed about their group allocation at the time of enrolment and consent.

Intervention Description: The intervention will consist of a mobile-based mindfulness therapy, specifically designed and delivered through a mobile application developed for this study. The intervention is based on mindfulness-based meditation practices and delivered digitally through the mobile application. The intervention will be carried out on an individual basis, with participants engaging mindfulness meditation sessions independently at their own convenience. Participants will access and engage with the intervention at home or any preferred location using their personal mobile devices. Participants in the intervention group will be instructed to complete daily mindfulness meditation sessions, each lasting 5–10 minutes, for a period of 8 consecutive weeks. Multiple sessions will be available each day through the application, with participants encouraged to engage in at least one session per day for the 8-week period. The intervention is self-administered through the mobile application. No external facilitator or therapist will deliver the sessions directly. However, the participants will be free to contact the research team for any question or concern

Control Group Description: Participants in the waitlisted control group will not receive the intervention during the initial 8-week study period. However, after completing the follow-up assessments at the end of 8 weeks, control group participants will be offered access to the same mobile-based mindfulness intervention if they wish to participate. The control group will receive no intervention during the study period. After 8 weeks, they will be offered access to the intervention, to be followed at their own convenience, identical to the experimental group.

Standard Care for Both Groups: During the study, both the intervention and waitlisted control groups will continue to receive standard antenatal care provided by the respective maternal hospitals and clinics. This includes routine antenatal check-ups, health education, and obstetric care as per hospital guidelines. The study intervention is an adjunct to standard care and does not replace any existing clinical or psychological support services. To reduce biases and to reduce risk for the participants, any mother who is under a standard psychological therapy will be excluded from the study.

• Pregnant mothers from the 6th and 7th months of the pregnancy (at the commencement of data collection), • Have access to a smart device • The pregnant mothers are required to have a considerable fluency to understand English or Sinhalese to be included into the study.

• Participants who are under any form of a therapy support for mental health problems • Further, mothers who have a history of suicidal thoughts or attempts (high risk) will be excluded from the study