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

Not Applicable

Not yet recruiting

• Conditions: Mobile Application; Behavior; Perinatal Mental Health

• Registration Number: NCT06862193
• Lead Sponsor: Karolinska Institutet

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).

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study Start: 2025-03-03
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 750

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mental wellbeing	Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)	Ryff's psychological wellbeing scale; Ryff's psychological wellbeing scale includes 18 items in which higher scores indicate greater psychological well-being (range 0-90). The scale includes items on self-reported autonomy, environmental mastery, personal growth, positive relations, purpose in life and self-acceptance. Responses are given on a seven-point Likert scale from "strongly agree" to "strongly disagree".; Reference: Ryff's Scales of Psychological Well-Being from Clarke, P. J., Marshall, V. M., Ryff, C. D., \& Wheaton, B. (2001). Measuring psychological well-being in the Canadian study of health and aging. International Psychogeriatrics, 13, 79-90. Translation to Swedish by Johanna Ekberg, Patricia Rosenberg \& Danilo Garcia. See Garcia D, Siddiqui A. (2009). Adolescents' psychological well-being and memory for life events: influences on life satisfaction with respect to temperamental dispositions. Journal of Happiness Studies, 10, 387-503. DOI: 10.1007/s10902-008-9096-3.

Secondary Outcome Measures

Name	Time	Method
Resilience	Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)	Connor-Davidson Resilience Scale (CDRISC); Connor-Davidson Resilience Scale (CDRISC) includes 10 items graded on a five-point scale from "not at all true" to "almost always true" measuring personal competence, acceptance of change and secure relationships, trust/tolerance/strengthening effects of stress, control and spiritual influences.
Postpartum attachment	Timepoint 2 (8-10 weeks post-partum)	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."; Reference: Brockington et al., (2006). The postpartum bonding questionnaire: A validation. Arch Womens Ment Health, 9, 233-242.
Depressive symptoms	Baseline (gestational week 10-12); timepoint 1 (gestational week 35-38); timepoint 2 (8-10 weeks post-partum)	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.; Reference: The Royal College of Psychiatrists 1987. Cox, J.L., Holden, J.M., \& Sagovsky, R. (1987). Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. British Journal of Psychiatry, 150, 782-786.
Prenatal attachment	Timepoint 1 (gestational week 35-38)	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.; Reference: Muller, (1993). Development of the Prenatal Attachment Inventory. West J Nurs Res, 15(2):199-211; discussion 211-5.
Parental self-efficacy	Timepoint 2 (8-10 weeks post-partum)	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. Reference: unpublished psychometric testing ongoing.
Fear of childbirth	Mid-intervention (gestational week 32)	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.; Reference: Haines et al., (2011). Cross-cultural comparison of levels of childbirth-related fear in an Australian and Swedish sample. Midwifery 27, 560-567.