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

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.

Study Overview

• Status: Recruiting
• Conditions: Behavior; Mobile Application; Perinatal Mental Health
• Intervention / Treatment: Behavioral: HealthyMoms4MentalHealth; Behavioral: HealthyMoms

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).

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Thomas Associate professor Thomas, PhD; Phone Number: +46722072203; Email: kristin.thomas@ki.se

Study Locations

• Sweden
  • Jönköping, Sweden
    • Recruiting
    • Region Jönköping
  • Kalmar, Sweden
    • Recruiting
    • Region Kalmar
  • Malmo, Sweden
    • Recruiting
    • Region Skane
  • Stockholm, Sweden
    • Recruiting
    • Region Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HealthyMoms (control group); The control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles.	Behavioral: HealthyMoms; Digital intervention focusing on lifestyle behaviours during the perinatal period.
Experimental: Intervention: HealthyMoms4MentalHealth; The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.	Behavioral: HealthyMoms4MentalHealth; The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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".	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.	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."	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.	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.	Mid-intervention (gestational week 32)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Physical activity, exercise, sedentary behaviour and screen time will be measured using six items. Two items are questions on the degree of physical activity during work and leisure time with a three-point response scale (sedentary to active). Four items are questions on the amount of time spent on screen time with a range from 0 to 14 hours weekly.	Weekly registrations from enrollment until intervention completion (8-9 weeks post-partum).
Self-compassion	The Self-Compassion Scale-Short Form (SCS-SF) The Self-Compassion Scale-Short Form (SCS-SF) is a 12-item scale graded on a five-point scale from "almost never" to "almost always". Self-compassion is measured in terms of self-kindness, self-judgment, common humanity, isolation, mindfulness and over identification.	Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum) and mid-intervention (gestational week 18-19)
Stressful life events	Stressful life events The Stressful Life Event Scale is a ten-item scale measuring life events such as divorce or health issues including when these events occurred (early life, during the last two years or never).	Baseline (gestational week 12-14); timepoint 2 (8-9 weeks post-partum)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Kristin Associate Professor Thomas, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior
• Other Study ID Numbers: HM4MH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No