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

NCT06862193 | Recruiting

• 1 other identifier: HM4MH
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 4

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.

Conditions

Mobile Application; Behavior; Perinatal Mental Health

Outcome Measures

Primary Outcomes (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.

  Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)

Secondary Outcomes (6)

• Depressive symptoms

  Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)

• Mental wellbeing

  Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)

• Prenatal attachment

  Timepoint 1 (gestational week 35-37)

• Postpartum attachment

  Timepoint 2 (8-9 weeks post-partum)

• Parental self-efficacy

  Timepoint 2 (8-9 weeks post-partum)

Other Outcomes (3)

• Physical activity

  Weekly registrations from enrollment until intervention completion (8-9 weeks post-partum).

• Self-compassion

  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

  Baseline (gestational week 12-14); timepoint 2 (8-9 weeks post-partum)

Study Arms (2)

HealthyMoms (control group)

ACTIVE COMPARATOR

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

Behavioral: HealthyMoms

Intervention: HealthyMoms4MentalHealth

EXPERIMENTAL

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

Behavioral: HealthyMoms4MentalHealth

Interventions

HealthyMoms4MentalHealth BEHAVIORAL

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

Intervention: HealthyMoms4MentalHealth

HealthyMoms BEHAVIORAL

Digital intervention focusing on lifestyle behaviours during the perinatal period.

HealthyMoms (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• Previous psychotic disorder

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (4)

Region Jönköping

Jönköping, Sweden

RECRUITING

Region Kalmar

Kalmar, Sweden

RECRUITING

Region Skåne

Malmo, Sweden

RECRUITING

Region Stockholm

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

• Kristin Associate Professor Thomas, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Thomas Associate professor Thomas, PhD

CONTACT

+46722072203; kristin.thomas@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 6, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-10

Locations

SE (4)