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Development and evaluation of a mobile-based mindfulness intervention for improving maternal mental health and neonatal outcomes: a randomized controlled trial with waitlisted control group

Development of a mobile-based mindfulness intervention and study of its effectiveness in improving maternal psychological wellbeing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2025/033
Enrollment
Unknown
Registered
2025-08-24
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Mental Health

Interventions

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 b

Sponsors

General Sir John Kotelawala Defence University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
Level of depression, anxiety, and stress measured by Depression, Anxiety and Stress Scale-21 (DASS-21) [Assessed at the baseline, after 8 weeks from the baseline, 2 months and 4 months after the delivery of the baby.] Level of psychological wellbeing using Psychological Wellbeing Scale developed by Ryff and Keyes (1995 [Assessed at the baseline, after 8 weeks from the baseline, 2 months and 4 months after the delivery of the baby.] Level of mindfulness using Mindful Attention Awareness Scale (MAAS) [ Assessed at the baseline, after 8 weeks from the baseline, 2 months and 4 months after the delivery of the baby.]

Secondary

MeasureTime frame
Baby’s birth recordings (APGAR score, birth weight, term of delivery, head size) [Birth]

Countries

Sri Lanka

Contacts

Public ContactLakshani Jayasinha

Principal Investigator

lakshani.j@nsbm.ac.lk0115445236

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Sep 19, 2026