Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT06862193
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-02', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'Weekly registrations from enrollment until intervention completion (8-9 weeks post-partum).', 'description': '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.'}, {'measure': 'Self-compassion', 'timeFrame': '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)', 'description': 'The Self-Compassion Scale-Short Form (SCS-SF)\n\nThe 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.'}, {'measure': 'Stressful life events', 'timeFrame': 'Baseline (gestational week 12-14); timepoint 2 (8-9 weeks post-partum)', 'description': 'Stressful life events\n\nThe 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).'}], 'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': 'Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)', 'description': 'The Edinburgh Postpartum Depression Scale\n\nThe 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.'}, {'measure': 'Mental wellbeing', 'timeFrame': 'Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)', 'description': '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".'}, {'measure': 'Prenatal attachment', 'timeFrame': 'Timepoint 1 (gestational week 35-37)', 'description': 'Prenatal Attachment Inventory (PAI)\n\nPrenatal 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.'}, {'measure': 'Postpartum attachment', 'timeFrame': 'Timepoint 2 (8-9 weeks post-partum)', 'description': 'Postpartum bonding questionnaire (PBQ)\n\nThe 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."'}, {'measure': 'Parental self-efficacy', 'timeFrame': 'Timepoint 2 (8-9 weeks post-partum)', 'description': 'Parental self-efficacy\n\nThe 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.'}, {'measure': 'Fear of childbirth', 'timeFrame': 'Mid-intervention (gestational week 32)', 'description': 'Fear of childbirth (FOB)\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mobile Application', 'Behavior', 'Perinatal Mental Health']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(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.\n\nExclusion Criteria:\n\n* Previous psychotic disorder'}, 'identificationModule': {'nctId': 'NCT06862193', 'briefTitle': 'Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Effectiveneness of a Digital Intervention (the HM4MH-app) on Perinatal Psychological Wellbeing: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HM4MH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HealthyMoms (control group)', 'description': 'The control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles.', 'interventionNames': ['Behavioral: HealthyMoms']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: HealthyMoms4MentalHealth', 'description': 'The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.', 'interventionNames': ['Behavioral: HealthyMoms4MentalHealth']}], 'interventions': [{'name': 'HealthyMoms4MentalHealth', 'type': 'BEHAVIORAL', 'description': 'The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.', 'armGroupLabels': ['Intervention: HealthyMoms4MentalHealth']}, {'name': 'HealthyMoms', 'type': 'BEHAVIORAL', 'description': 'Digital intervention focusing on lifestyle behaviours during the perinatal period.', 'armGroupLabels': ['HealthyMoms (control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jönköping', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Region Jönköping', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Kalmar', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Region Kalmar', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Region Skåne', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Region Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Kristin Thomas Associate professor Thomas, PhD', 'role': 'CONTACT', 'email': 'kristin.thomas@ki.se', 'phone': '+46722072203'}], 'overallOfficials': [{'name': 'Kristin Associate Professor Thomas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kristin Thomas', 'investigatorAffiliation': 'Karolinska Institutet'}}}}