The Effectiveneness of a Digital Intervention (the HM4MH-app) on Perinatal Psychological Wellbeing: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 4
- 主要终点
- Resilience
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •Previous psychotic disorder
研究组 & 干预措施
HealthyMoms (control group)
The control is a mobile application targeting women during the perinatal period, focusing on healthy lifestyles.
干预措施: HealthyMoms (Behavioral)
Intervention: HealthyMoms4MentalHealth
The intervention is a mobile application targeting women during the perinatal period, aiming to promote mental wellbeing.
干预措施: HealthyMoms4MentalHealth (Behavioral)
结局指标
主要结局
Resilience
时间窗: Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
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.
Resilience
时间窗: Baseline (gestational weeks 12-14); timepoint 1 (gestational week 35-37); timepoint 2 (8-9 weeks post-partum)
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.
次要结局
- Fear of childbirth(Mid-intervention (gestational week 32))
- 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))
- 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))
- Fear of childbirth(Mid-intervention (gestational week 32))
研究者
Kristin Thomas
Principal investigator
Karolinska Institutet