Mobile ApplicationNCT06862193
Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing
A study testing HealthyMoms4MentalHealth and HealthyMoms in people with Mobile Application and Behavior, run by Karolinska Institutet at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mobile Application, Behavior, Perinatal Mental Health
- What is being tested?
- HealthyMoms4MentalHealth and HealthyMoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 4 sitesSweden
- Study dates
- 10 Mar 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous psychotic disorder
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Region Jönköping
Jönköping
- Recruiting
Region Kalmar
Kalmar
- Recruiting
Region Skåne
Malmö
- Recruiting
Region Stockholm
Stockholm
About this study
Official title: The Effectiveneness of a Digital Intervention (the HM4MH-app) on Perinatal Psychological Wellbeing: Randomized Controlled Trial
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.
Read the detailed description
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 therefore to investigate the effectiveness of a new digital tool (HealthyMoms4MentalHealth-app) on mental health outcomes during the perinatal period. The tool has been developed tailored to the pregnancy and postpartum period.
The study is a two-arm parallel groups multi-centre randomised controlled trial where pregnant women (n=750) will be randomised (1:1) to either an intervention (HealthyMoms4MentalHealth-app) or control group (HealthyMoms-app). Primary outcome (mental wellbeing) and secondary outcomes (resilience, depressiveness, attachment, fear of childbirth) together with mediators (self-compassion and physical activity) will be measured at baseline (gestational week 10-12), timepoint 1 (gestational week 35-38) and timepoint 2 (8-10 weeks postpartum). Baseline will also assess demographic data (age, employment, education, birth country, living situation and number of children). Stressful life events will also be measured as potential confounding variable at baseline and timepoint 2 (8-10 weeks postpartum). In addition, information on obstetric and neonatal outcomes will be collected as continuous variables or incidence from medical records (Obstetrix®Cerner). They include gestational weight gain, caesarean section, infant birth weight and length and incidence of large-for gestational-age infant (birth weight >90th percentile for gestational age and gender).
- Conditions
- Mobile Application, Behavior, Perinatal Mental Health
- Being tested
- HealthyMoms4MentalHealth, HealthyMoms
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyMoms4MentalHealthBehavioural
The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.
HealthyMomsBehavioural
Digital intervention focusing on lifestyle behaviours during the perinatal period.
| Study group | Role | What they receive |
|---|---|---|
| HealthyMoms (control group) | Active comparator | The control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles. Receives: Behavioral: HealthyMoms |
| Intervention: HealthyMoms4MentalHealth | Experimental | The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing. Receives: Behavioral: HealthyMoms4MentalHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
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.
Measured: Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
Secondary outcomes (6)
Depressive symptoms
The Edinburgh Postpartum Depression Scale
The Edinburgh Postpartum Depression Scale includes ten items graded on a four-point ordinal scale in which higher scores indicate increased depressive symptoms (range 0-30). The clinical cut-off used in Sweden for postpartum depression is >12.
Measured: Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
Mental wellbeing
Mental wellbeing will be measured with the Ryff Scales of Psychological Well-Being (RPWB), which includes 18 items. For this scale, higher scores indicate greater psychological well-being (range 18-108) and responses are given on a six-point Likert scale from "strongly disagree" to "strongly agree".
Measured: Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
Prenatal attachment
Prenatal Attachment Inventory (PAI)
Prenatal Attachment Inventory assess emotional attachment to the fetus using 21 items. Responses are made on a four-point likert scale and scores may range from 21 to 84 with higher scores indicating increased attachment quality/intensity.
Measured: Timepoint 1 (gestational week 35-37)
Postpartum attachment
Postpartum bonding questionnaire (PBQ)
The Postpartum Bonding Questionnaire is a 25 item screening questionnaire for mother-infant bonding disorders. Items are rated on a 6-point scale ranging from "Always" to "Never."
Measured: Timepoint 2 (8-9 weeks post-partum)
Parental self-efficacy
Parental self-efficacy
The parental self-efficacy scale is a 17 item questionniare measuring parental self-efficacy with responses on a 7 point likert scale ranging from strongly disagree to strongly agree. Higher scores indicate higher self-reported parental self-efficacy.
Measured: Timepoint 2 (8-9 weeks post-partum)
Fear of childbirth
Fear of childbirth (FOB)
The the Fear of Birth Scale (FOBS) is a short instrument that measures fear of childbirth during pregnancy. It consists of two 100 mm Visual Analogue Scales (VAS) that are summed and averaged to get a score.
Measured: Mid-intervention (gestational week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Thomas, Karolinska Institutet
- Investigators
- Kristin Associate Professor Thomas, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862193
- Sponsor's protocol ID
- HM4MH
- Status last verified
- Oct 2025
- First submitted
- 20 Feb 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lof M, Ekelof K, Nystrom CD, Lonnberg G, Ljotsson B, Tangen GA, Lilliecreutz C, Thomas K. Promoting psychological resilience during the perinatal period with a digital tool (the HealthyMoms4MentalHealth-app): a study protocol for a randomised controlled trial in Sweden. BMC Public Health. 2026 Oct 3;26(1):2950. doi: 10.1186/s12889-026-26804-8.
PubMed 42870238