Can a co-developed mHealth application effectively reduce pregnancy-related anxiety compared to the standard antenatal care and improve the key obstetric outcomes among pregnant women at a tertiary hospital in Sri Lanka?

Study Design: Open-label, randomized controlled trial (RCT) with parallel design and pre- and post-intervention outcome assessment. Individual participant level 1:1 random assignment will place participants in either the control group (standard prenatal care) or the intervention group (mHealth intervention). The SPIRIT 2025 statement guidelines regarding randomized trials were followed in the study design.

Study setting: Antenatal clinics at the Professorial unit of De Soysa Hospital for Women (DSHW) in Colombo.

Study population:
Pregnant women who attend the antenatal clinic at the Professorial unit of De Soysa Hospital for Women (DSHW) and meet the inclusion and exclusion criteria.

Intervention Arm: Co-developed Mobile Health (mHealth) Application:

Participants in the intervention group will receive access to a co-developed mobile health application designed to reduce pregnancy-related anxiety. The app was developed with input from pregnant women, midwives, obstetricians, psychologists, and IT specialists to ensure cultural relevance and usability in the Sri Lankan context.

Participants are expected to complete five psychoeducation modules (one-time completion), two visualization sessions per week (16 total over 8 weeks), and two breathing sessions per day (112 total over 8 weeks).The mHealth application includes the following intervention components:

1. Psychoeducation Module: Psychoeducation consists of 5 modules as follows: Module 1: What is pregnancy-related anxiety? Module 2: Common anxieties during pregnancy Module 3: What to expect during pregnancy (Navigating physical and emotional changes during pregnancy) Module 4: Preparing for Birth and Postpartum Module 5: Managing Worry and Stress during Pregnancy. These are simple, evidence-based information about pregnancy-related anxiety, normal emotional changes, coping strategies, and when to seek help. All the psychoeducation modules are available in the application but are locked. Only the first module will be kept unlocked. Once participants complete the first module, they will provide a rating from 1-5 on the module's usefulness, after which the second module will be unlocked. The same process will be followed for the rest of the psychoeducation module. Participants will continue to have access to previously unlocked psychoeducation modules throughout the intervention period.

2. Mindful Breathing Exercise: Guided breathing exercise to promote relaxation and reduce anxiety symptoms. An audio instruction and a visual of a breathing exercise are provided.

3. Visualization Exercise: Short, calming visualizations to support emotional regulation and positive birth expectations. An audio instruction and a visual of a visualization exercise are provided.

In addition to the above three main interventions, we have the following two features.

Self-monitoring Tools: o Daily mood tracking o Reminder prompts

Practical Support Features: o Week-by-week pregnancy guide o FAQs on pregnancy concerns o Emergency contacts o Support contact details (e.g., trainee health psychologist)

Participants will be asked to use the app daily for a period of 8 weeks, in addition to continuing their routine antenatal care at their respective clinics or hospitals. Usage is self-paced, and participants can engage with any module at their convenience.

No medication or invasive procedures are involved. The intervention is purely psychological and behavioral, delivered through a mobile application. Usage of these intervention components is monitored via backend analytics, which involves the process of gathering, processing, and analyzing data on the server-side of the software application.

Participants are expected to complete at least two psychoeducation sessions each week, two visualization sessions each week, and two breathing sessions per day during the intervention period. If participants do not reach the above limit, they will not be excluded from the study. They will be followed up on and encouraged to reach the limit.

Participants in the intervention group will also receive usual antenatal care provided through their chosen routine government and/or private maternal health services.

Control Arm: Standard Antenatal Care

Participants in the control group will receive usual antenatal care provided through their chosen routine government and/or private maternal health services, without access to the mHealth application during the trial period.

Blinding will be achieved as follows:

The principal investigator, administrators, and data analysts will be blinded to minimize bias. Randomization and intervention administration will be conducted solely by the designated Research Assistant, who will also monitor participant activity completion through direct follow-up and backend checks supported by the software development team. Outcome assessments and statistical analyses will be performed by an independent statistician who will be blinded to group assignments throughout. Importantly, the principal investigator will not be involved in randomization, intervention delivery, monitoring, outcome assessment, or data analysis, ensuring complete separation from all processes that could introduce bias. Only the participants will not be blinded to the allocation.

1. Pregnant women with uncomplicated singleton pregnancies with a period of gestation between 12 and 28 weeks.
2. Pregnant women who can read and comprehend Tamil or Sinhala (since the intervention is bilingual).
3. Pregnant women who scored mild to moderate levels on the Pregnancy-related Anxiety Questionnaire Revised 2, translated and validated through the Delphi process, as well as an additional screening step by a consultant psychiatrist to exclude severe anxiety and depression.
4. Pregnant women who have access to an Android or iOS smartphone or tablet with an internet connection

1. Pregnant women with a documented diagnosis of a major mental disorder, such as major depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, and personality disorders.
2. Pregnant women who have previously enrolled in a similar digital mental health intervention.