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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
HealthyMoms4MentalHealth and HealthyMoms
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
Are there results?
Not yet: the study is under way

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.

Kristin Thomas Associate professor Thomas, PhD contact

+46722072203

kristin.thomas@ki.se

Sweden4 sites, 4 recruiting

  • Region Jönköping

    Jönköping

    Recruiting

  • Region Kalmar

    Kalmar

    Recruiting

  • Region Skåne

    Malmö

    Recruiting

  • Region Stockholm

    Stockholm

    Recruiting

Other trials in Sweden

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).

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 groups in NCT06862193
Study groupRoleWhat they receive
HealthyMoms (control group)Active comparatorThe control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles.
Receives: Behavioral: HealthyMoms
Intervention: HealthyMoms4MentalHealthExperimentalThe 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.

  1. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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.

  1. First posted6 Mar 2025
  2. Study start10 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A study testing HealthyMoms4MentalHealth and HealthyMoms in people with Mobile Application and Behavior, run by Karolinska Institutet at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristin Thomas Associate professor Thomas, PhD (+46722072203, kristin.thomas@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resilience (time frame: Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06862193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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