Ireland
--:--IST
Recruiting Not applicable

Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing

NCT06862193 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-03-10
Last updated
2025-12-22

Condition(s) studied

Mobile ApplicationBehaviorPerinatal Mental Health

Investigational drug(s) / intervention(s)

HealthyMoms4MentalHealthHealthyMoms

HealthyMoms4MentalHealth: The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.

HealthyMoms: Digital intervention focusing on lifestyle behaviours during the perinatal period.

Study summary

As many as 25% of pregnant women report mental health problems such as depressiveness and anxiety. This is a major concern as mental illness during pregnancy can have severe and long-lasting consequences for the pregnant woman, the baby, as well as the partner. Digital interventions (e.g., apps) have shown to be promising in promoting mental wellbeing, at scale, however, the majority of tools have been developed and evaluated in a general population rather than tailored for pregnancy. The objective of this trial is to investigate the effectiveness of a new digital tool (HealthyMoms4MentalHealth-app) on mental health outcomes during the perinatal period.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: (i) pregnant women attending a participating maternity health care centre who (ii) have access to their own mobile phone and BankID and is (iii) currently in gestational week 8-15 and (iv) is 18 years or older. Exclusion Criteria: * Previous psychotic disorder

Primary outcome measure(s)

  • Resilience — Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
    Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC-10) which includes 10 items graded on a five-point scale from "not at all true" to "almost always true". The items assess various aspects of resilience, such as emotional regulation, optimism, personal strength, and the ability to manage stress. Lower scores suggest lower resilience and possibly a greater vulnerability to stress and adversity whereas higher scores suggest higher resilience, meaning the individual is likely to be better equipped to handle stress or challenges.

Trial sites (4)

FacilityCityRegionStatus
Region Jönköping Jönköping Sweden Recruiting
Region Kalmar Kalmar Sweden Recruiting
Region Skåne Malmö Sweden Recruiting
Region Stockholm Stockholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06862193 on ClinicalTrials.gov ↗ ← All trials in Sweden