Actively Recruiting
Effectiveness of the HealthyMoms4MentalHealth Digital App on Perinatal Psychological Wellbeing: Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2025-12-22
440
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Many pregnant women experience mental health challenges such as depression and anxiety, which can have serious and lasting effects on the woman, her baby, and her partner. Researchers are studying a new digital tool called the HealthyMoms4MentalHealth app, designed specifically for pregnancy and postpartum, to see if it can improve mental health during the perinatal period. This trial compares this new app with a general HealthyMoms app that focuses on healthy lifestyle behaviors during pregnancy. The study is a randomized controlled trial with two groups: one group uses the HealthyMoms4MentalHealth app aimed at promoting mental wellbeing, while the control group uses the HealthyMoms app focusing on healthy lifestyles. A total of 750 pregnant women will participate, starting between 8 and 15 weeks of pregnancy. Participants will be evaluated at three time points: early pregnancy (gestational weeks 10-12), late pregnancy (weeks 35-38), and postpartum (8-10 weeks after birth). During the study, researchers will collect information through questionnaires measuring mental wellbeing, resilience, depression, attachment to the baby, fear of childbirth, and parental self-efficacy. They will also gather medical record data about birth outcomes like weight gain, delivery method, and infant size. Assessments will occur at baseline, late pregnancy, and postpartum to track changes. The total study participation covers pregnancy through early postpartum, with regular follow-up to monitor mental health and related factors.
CONDITIONS
Brief Title
Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women attending a participating maternity health care centre
- Have access to their own mobile phone and BankID
- Currently between gestational weeks 8 and 15
- Age 18 years or older
You will not qualify if you...
- Previous diagnosis of a psychotic disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From gestational weeks 12-14 to 8-9 weeks postpartum
Participants use a digital mobile application tailored for the perinatal period to promote mental wellbeing or focus on healthy lifestyles during pregnancy and postpartum.
3 visits at baseline, mid-intervention, and postpartum assessments
Duration - Up to 8-9 weeks postpartum
Participants complete follow-up assessments on mental wellbeing, depression, attachment, and parental self-efficacy postpartum.
1 follow-up visit 8-9 weeks postpartum
Trial Site Locations
Total: 4 locations
1
Region Jönköping
Jönköping, Sweden
Actively Recruiting
2
Region Kalmar
Kalmar, Sweden
Actively Recruiting
3
Region Skåne
Malmö, Sweden
Actively Recruiting
4
Region Stockholm
Stockholm, Sweden
Actively Recruiting
Research Team
K
Kristin Thomas Associate professor Thomas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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