Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKarolinska Institutet
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Previous psychotic disorder
Trial design
Design model
Parallel
Treatments tested in this trial
HealthyMoms4MentalHealth
BehavioralThe intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.
HealthyMoms
BehavioralDigital intervention focusing on lifestyle behaviours during the perinatal period.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: HealthyMoms (control group)Active comparator 1 intervention
Group B: Intervention: HealthyMoms4MentalHealthExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)Secondary outcomes
1
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.
Time frame
Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)2
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".
Time frame
Baseline (gestational week 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)3
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.
Time frame
Timepoint 1 (gestational week 35-37)4
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."
Time frame
Timepoint 2 (8-9 weeks post-partum)Other outcomes
1
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.
Time frame
Weekly registrations from enrollment until intervention completion (8-9 weeks post-partum).2
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.
Time frame
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)3
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).
Time frame
Baseline (gestational week 12-14); timepoint 2 (8-9 weeks post-partum)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov