HealthyMoms4MentalHealth app to support mental wellbeing in pregnancy
Official title: The Effectiveneness of a Digital Intervention (the HM4MH-app) on Perinatal Psychological Wellbeing: Randomized Controlled Trial
Run by Karolinska Institutet · NCT06862193 · Data updated 2026-11-12
This project will test whether the HealthyMoms4MentalHealth app can help pregnant women feel mentally better during pregnancy and the first weeks after birth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 440 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 4 sites (Jönköping and 3 other locations) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06862193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 or older in gestational week 8–15 who attend a participating maternity health centre and have their own smartphone and Swedish BankID are ideal candidates.
✕Probably not a fit
People with a history of psychotic disorder, those without a smartphone or BankID, or those with severe mental health needs requiring specialised care are unlikely to benefit from this app-based intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre, two-arm parallel randomised controlled trial enrolling 750 pregnant women who will be randomised 1:1 to the HealthyMoms4MentalHealth intervention app or the control HealthyMoms app. Participants are recruited at participating maternity health centres and complete baseline measures in gestational week 10–12, with follow-ups at week 35–38 and 8–10 weeks postpartum. The primary outcome is mental wellbeing, with secondary outcomes including resilience, depressive symptoms, parent–infant attachment and fear of childbirth, and mediators such as self-compassion and physical activity. Baseline demographic data and stressful life events are collected to control for confounding.
Why it matters
Potential benefit: If successful, the app could improve perinatal mental wellbeing and reduce symptoms of depression and anxiety for pregnant women at scale.
How similar studies have gone: App-based mental health interventions have shown promise in general populations, but pregnancy-tailored digital tools have been less thoroughly tested, making this partly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Region Jönköping
Jönköping, Sweden Recruiting -
Region Kalmar
Kalmar, Sweden Recruiting -
Region Skåne
Malmö, Sweden Recruiting -
Region Stockholm
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Kristin Associate Professor Thomas, PhD — Karolinska Institutet
- Study coordinator: Kristin Thomas Associate professor Thomas, PhD
- Email: kristin.thomas@ki.se
- Phone: +46722072203
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.