Clinical trial NCT06862193: Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing
Official title: The Effectiveneness of a Digital Intervention (the HM4MH-app) on Perinatal Psychological Wellbeing: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobile Application
Behavior
Perinatal Mental Health
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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: 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).

Eligibility 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

Primary outcomes:
measure: Mental wellbeing
timeFrame: Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)
measure: Resilience
timeFrame: Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)
measure: Prenatal attachment
timeFrame: Timepoint 1 (gestational week 35-38)
measure: Postpartum attachment
timeFrame: Timepoint 2 (8-10 weeks post-partum)
measure: Parental self-efficacy
timeFrame: Timepoint 2 (8-10 weeks post-partum)
measure: Fear of childbirth
timeFrame: Mid-intervention (gestational week 32)
Other outcomes:
measure: Physical activity
timeFrame: Weekly registrations from enrollment until intervention completion (8-10 weeks post-partum).
measure: Self-compassion
timeFrame: Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum) and mid-intervention (gestational week 18-19)
measure: Stressful life events
timeFrame: Baseline (gestational week 10-12); timepoint 2 (8-10 weeks post-partum)
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Kristin Associate Professor Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References: