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

NCT ID: NCT06862193

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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

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Perinatal Mental Health Mobile Application Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HealthyMoms (control group)

The control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles.

Group Type ACTIVE_COMPARATOR

HealthyMoms

Intervention Type BEHAVIORAL

Digital intervention focusing on lifestyle behaviours during the perinatal period.

Intervention: HealthyMoms4MentalHealth

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

Group Type EXPERIMENTAL

HealthyMoms4MentalHealth

Intervention Type BEHAVIORAL

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

Interventions

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HealthyMoms4MentalHealth

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

Intervention Type BEHAVIORAL

HealthyMoms

Digital intervention focusing on lifestyle behaviours during the perinatal period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Kristin Thomas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Associate Professor Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Region Jönköping

Jönköping, , Sweden

Site Status RECRUITING

Region Kalmar

Kalmar, , Sweden

Site Status RECRUITING

Region Skåne

Malmo, , Sweden

Site Status RECRUITING

Region Stockholm

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Kristin Thomas Associate professor Thomas, PhD

Role: CONTACT

Phone: +46722072203

Email: [email protected]

Other Identifiers

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HM4MH

Identifier Type: -

Identifier Source: org_study_id