The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: * Does the app improve overall maternal well-being during the perinatal period? * Can the app increase the early detection rates of perinatal mental health disorders? * Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? * How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: * Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. * Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. * Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.
BACKGROUND: Mental disorders are becoming one of the major health problems in today's society, exacerbated in women who are and will become mothers. Global studies indicate that 80% of women who are going to become mothers experience mood disorders such as stress, fear, loneliness, or guilt during the perinatal period. In 1 out of every 5 cases, these mental disorders worsen and lead to severe mental health issues such as post-traumatic stress disorder, psychosis, suicidal ideation, or postpartum depression. However, 75% of women with perinatal mental disorders are underdiagnosed and do not receive adequate treatment, either due to a lack of detection or support within healthcare systems. This has a consequent impact on the health and well-being of the mother, her family, the child, and ultimately, society. In this context, the company A Thousand Colibris S.L (ATC) has developed digital health software to improve well-being during this period, as well as to detect, assist in the diagnosis, and monitor mental health disorders in mothers from pregnancy up to two years after childbirth. Consequences of Perinatal Mental Health Disorders: The consequences of perinatal mental health problems extend beyond the mother, affecting the child, the family, and society as a whole. 1. Maternal health disorders: Perinatal mental health disorders have been identified in women of all cultures, ages, social levels, and races. Although the term postpartum depression is often used to describe disorders that develop after childbirth, a range of disorders can appear during pregnancy and the postpartum period, including anxiety, depression, stress disorders, panic, or postpartum psychosis. If left untreated, these illnesses can have a devastating impact on women and their families, being one of the leading causes of maternal death during pregnancy and the two years following childbirth. 2. Impact on the future health of the child: Without appropriate intervention, these disorders can persist and have negative consequences for both the mother and the baby. The impact of the mother's health on the future health of the baby, on mother-newborn interactions, breastfeeding difficulties, and the mother-child bond is well documented. The failure to detect certain aspects of maternal health can manifest in complications during childbirth or later in the child's development. 3. Impact on family well-being: The mother's mood and symptoms of anxiety and other disorders also have a direct impact on the partner, who may not understand what is happening, feel overwhelmed, and not know how to help. Digital psychological interventions: Given the growing ubiquity of the Internet and the widespread use of smartphones, mindfulness-based cognitive-behavioral interventions can also be offered digitally. In this regard, researchers have been successfully adapting decades-old techniques commonly used in cognitive-behavioral therapies to the context of smartphone applications, which have demonstrated efficacy in reducing symptoms of depression, anxiety, stress, insomnia, and even suicidal thoughts. However, the potential of smartphone applications in promoting well-being, and preventing and treating mental health problems in pregnant women, has yet to be fully exploited. Despite the limited number of studies and controlled trials involving health apps for pregnant women, online app stores are flooded with pregnancy apps that have not been tested using rigorous scientific methods. This has sparked an increasing debate among researchers and policymakers regarding the evaluation of quality and certification of health apps that do not meet the needs of patients and doctors, particularly concerning safety and efficacy. Health applications should be evaluated with the same rigor as other types of interventions, such as pharmacotherapy and psychotherapy. HYPOTHESES: Hypothesis 1: Dana is a digital tool that improves the well-being of women transitioning into motherhood and increases the early detection of mental health disorders. Hypothesis 2 (Class IIa Certification): The tool provides monitoring of maternal health and assists in diagnosis for healthcare professionals. OBJECTIVES: General: To validate a digital tool as a solution to (a) improve maternal well-being, mental and physical health during the perinatal period, (b) increase early detection of maternal mental health disorders, and (c) assist in the diagnosis and monitoring of perinatal mental health problems. Specific: * Validate the effectiveness of the digital tool in improving well-being at the end of pregnancy (34 weeks gestation), initial postpartum (6 weeks postpartum), and long-term (6, 12, and 24 months postpartum). * Verify the effectiveness of the digital tool in preventing symptoms of anxiety and depression during the perinatal period (pregnancy and postpartum up to 24 months postpartum). * In women with symptoms detected in the baseline assessment, analyze the effectiveness of the tool in preventing symptom escalation. * In women with stabilized mental pathology, analyze the effectiveness of the tool in preventing symptom escalation. * Verify the effectiveness of the digital tool in improving secondary outcomes related to childbirth: childbirth experience and postpartum-related post-traumatic stress. * Verify the effectiveness of the digital tool in improving obstetric and neonatal health secondary outcomes. * Analyze the use of healthcare services and the cost of perinatal mental health. * Verify the effectiveness of the intervention developed to increase prenatal bonding and postpartum attachment. * Verify the effectiveness of the intervention developed to improve postpartum secondary outcomes: satisfaction with the maternal role, self-efficacy, stress with the maternal role, and proportion of breastfeeding. * Analyze the secondary relationship between childbirth experience, post-traumatic stress, and postpartum depression. * Analyze the data collected by the digital tool and wearables to identify patterns and correlations that may be useful for the prediction and early detection of disorders in mothers and babies. * Analyze infant neurodevelopment and psychopathology during the first two years of life. METHODOLOGY: 1. Design: A randomized clinical trial, blinded to the investigator, with two parallel groups (1 experimental group using the digital tool and 1 control group). The protocol has been designed following the CONsolidated Standards Of Reporting Trials (CONSORT: http://www.consortstatement.org) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). 2. Participants: The study will be conducted at Vall d'Hebrón Hospital, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona, ASSIR del Litoral (Barcelona), and Hospital del Mar. Participants will be pregnant women between 12-14 weeks of gestation who are following their pregnancy at these centers, and they and their babies will be followed up until 24 months postpartum. 3. Sample Size: To estimate the necessary sample size to detect significant differences between groups, an alpha risk error of 0.05 and a beta risk error of 0.2 for one-tailed tests have been accepted, considering a dropout rate of 40%. According to data from Viskovich et al. (2020) and Rash et al. (2011) related to the Satisfaction With Life Scale, 16 subjects per group are needed to determine minimum differences of 1.86 points, assuming a standard deviation of 2.07 points. According to data from Tovote et al. (2014) related to the World Health Organization-5 Well-Being Index, 11 subjects per group are needed to determine minimum differences of 20.6 points, assuming a standard deviation of 19.0 points. According to data from Ahlqvist-Björkroth et al. (2019) related to the Edinburgh Postnatal Depression Scale, 26 subjects per group are needed to determine minimum differences of 2.13 points, assuming a standard deviation of 2.46 points. Finally, according to data from Moix et al. (2021) related to the State-Trait Anxiety Inventory, 11 subjects per group are needed to determine minimum differences of 5.54 points, assuming a standard deviation of 4.5 points. Thus, 64 subjects per arm are needed, so a total sample of 300 pregnant women per center should be recruited. 4. Procedures: 4.1. Recruitment: Participants will be recruited through midwives from the Primary Care Centers and Sexual and Reproductive Health Care Services (ASSIR) of Tarragona, and ASSIR of Barcelona Litoral - Hospital del Mar. Recruitment will be through obstetricians and midwives from the same center. Women who visit before 15 weeks of gestation and meet the inclusion and exclusion criteria will be eligible to participate in the study. The healthcare professional conducting the visit will be responsible for validating the inclusion and exclusion criteria. 4.2. Randomization: Balanced randomization by center will be carried out through the digital tool itself, so the researchers will be blind to the intervention. Participants will need to download the mobile application, where during the registration process and center selection, they will be randomized into the control or intervention group. Women in the intervention group will be offered access to the full digital tool, while those in the control group will have an app with no content. 4.3. Blinding: Researchers analyzing the primary data and conducting infant evaluations will not know which group the women have been assigned to. Midwives and obstetricians who conduct recruitment will also be unaware, unless the participant discloses it after being randomized. Neither the researchers nor the midwives will have access to group assignments. Researchers conducting primary data analysis or neonatal evaluations will not know the participants' group assignments until the end of the study. Due to the nature of the intervention, participants cannot be blinded to their group assignment. 4.4. Pseudonymization: Data pseudonymization and protection will be ensured using the REDCap system. Each participating health center and hospital (as independent data controllers) will have access only to their own center's data, not to data from other centers. Data from the entire study recorded in REDCap and app data will be accessible only by the co-sponsors and co-controllers of the data mentioned in the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
The intervention that has been developed is a digital tool of a biopsychosocial nature based on the main cognitive-behavioral strategies: psychoeducation, reflection, self-observation, guided visualizations, mindfulness and progressive muscle relaxation. The intervention consists of 3 main areas of work: * Programs: Biopsychosocial programs in text and audio format. * Community: Forum with directed questions and space to share experiences between mothers. * Diary: Space to record mood and emotional record. The entire tool works transversally in 4 dimensions: self-care, relationship with perinatal changes, relationship with the baby, social relationship. The tool itself includes 3 mental health and well-being screening questionnaires: Whooley Questionnaire and the Edinburgh Postnatal Depression Scale (EPDS).
Participants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGASSIR Tarragona
Tarragona, Spain
RECRUITINGMaternal well-being
Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021). Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression.
Time frame: 12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum.
Depression
Using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire for detecting postpartum depression symptoms, validated for pregnancy and in Spanish women (Levis et al., 2020; Vázquez \& Míguez, 2019). Min value: 0 Max value: 30 Higher scores: Indicate worse symptoms. Scores ≥10 suggest possible depression; scores ≥13 or positive for question 10 indicate a high likelihood.
Time frame: 12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.
Anxiety
Using the State-Trait Anxiety Inventory (STAI), a 40-item tool for assessing state and trait anxiety (Brunton et al., 2015). Min value: 20 per subscale (STAI-S and STAI-T) Max value: 80 per subscale Higher scores: Indicate worse anxiety outcomes.
Time frame: 12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.
Birth Fear
Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A-B), a 33-item tool to quantify fear of childbirth. Min value: 0 Max value: 165 Higher scores: Indicate higher levels of fear; scores \>85 suggest high fear levels.
Time frame: 12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum.
Sleep
Using the Pittsburgh Sleep Quality Index (PSQI), a 19-item tool to assess sleep quality over the past 30 days. Min value: 0 Max value: 21 Higher scores: Indicate worse sleep quality; scores \>5 suggest poor sleep.
Time frame: 12-14 and 33-34 weeks of pregnancy
Maternal Antenatal attachment
Using the Maternal Antenatal Attachment Scale (MAAS) to assess the emotional bond with the unborn child. Min value: 19 Max value: 95 Higher scores: Indicate a stronger emotional bond.
Time frame: 29-30 weeks of pregnancy.
Bonding
Using the Postpartum Bonding Questionnaire (PBQ) to measure the maternal bond with the baby post-birth. Min value: 0 Max value: 125 Higher scores: Indicate worse bonding outcomes.
Time frame: 6 weeks, 6, 12, 24 months postpartum.
Birth Experience
Using the Mackey Satisfaction Childbirth Questionnaire to measure childbirth satisfaction. Min value: 11 Max value: 55 Higher scores: Indicate higher satisfaction.
Time frame: 33-34 weeks of pregnancy, 6 weeks postpartum.
Traumatic stress responses related to childbirth
The City Birth Trauma Scale (BiTS): Psychological assessment tool designed to measure traumatic stress responses specifically related to childbirth. It is used to identify symptoms of birth-related post-traumatic stress disorder (PTSD) in women who have recently given birth. The scale helps healthcare providers to assess the severity and impact of traumatic childbirth experiences on mothers. Minimum value: 0 Maximum value: 80 Higher scores: Indicate more severe symptoms of trauma related to childbirth.
Time frame: 6 weeks postpartum
Parental stress
Parental Stress Index (PSI): This evaluation tool measures parental stress levels in mothers and fathers. The PSI consists of 36 questions that evaluate different factors that may contribute to parental stress, such as the child's health, the relationship with the partner, social support, work demands, and parental expectations regarding the child's development. Min value: 36 Max value: 180 Higher scores: Indicate higher stress levels.
Time frame: 6, 12, 24 months postpartum.
Maternal empowerment
Parenting Sense of Competence (PSOC): This evaluation tool measures the perception of parental competence in mothers and fathers. The PSOC consists of 16 questions that evaluate satisfaction with the parental role, confidence in parenting skills, the ability to adapt to the child's demands, and the perception that the parental role is a rewarding task. The questionnaire is used to identify parents who may need additional support to develop confidence and parenting skills, and improve family health and well-being. Minimum value: 16 Maximum value: 96 Higher scores: Indicate better perceived parental competence.
Time frame: Postpartum: 6 weeks and 24 months
Physical Activity
Using the International Physical Activity Questionnaire (IPAQ) to measure physical activity levels. Min value: 0 Max value: Varies based on intensity and frequency Higher scores: Indicate higher physical activity levels.
Time frame: 12-14 and 33-34 weeks of pregnancy.
Pregnancy outcomes
Pregnancy complications (measured in presence of gestational diabetes, preeclampsia, preterm birth, growth restriction, diagnosis of perinatal mental health disorder, need for psychotropic drugs, smoking habit). Higher values: Indicate higher complications during pregnancy.
Time frame: 1 week after birth collected retrospectively for pregnancy and childbirth
Health costs 1
Cost for the healthcare system (measured on number of visits to obstetrician/gynecology, midwife, psychology, physiotherapy, emergency room, hospital admissions) Higher values: Indicate higher expenses for the healthcare system.
Time frame: 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.
Health costs 2
Duration of hospital admission (measured in days). Higher values: Indicate higher expenses for the healthcare system.
Time frame: 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.
Neonatal outcomes 1
Gestational age at delivery (weeks+days) Normal range: 37-42 weeks Lower values: Indicate preterm newborns. Higher values: Indicate postterm newborns.
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 2
Cord arterial pH (potential of hydrogen) Normal pH: Range: 7.25 to 7.35 Implication: Indicates that the newborn had adequate oxygenation and no significant acidosis during labor and delivery. Mild Acidosis: Range: 7.20 to 7.24 Implication: Suggests a slight decrease in oxygen levels. While it may not immediately be cause for concern, it warrants monitoring for any signs of distress or complications. Moderate Acidosis: Range: 7.10 to 7.19 Implication: Indicates moderate hypoxia and the possibility of metabolic acidosis. This condition may require intervention and close monitoring of the newborn for any further complications. Severe Acidosis: Range: Below 7.10 Implication: Suggests significant hypoxia and severe metabolic acidosis, which can be associated with perinatal asphyxia. Immediate medical evaluation and intervention are typically required to address any potential adverse outcomes.
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 3
Neonatal complications at birth (descriptive: admission to the ICU, neonatal sepsis)
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 4
Apgar score: The Apgar score is a quick test performed on a newborn at 1 minute and 5 minutes after birth. The purpose of the test is to determine how well the baby tolerated the birthing process and how well the baby is doing outside the mother's womb. The Apgar score assesses five criteria, each scored on a scale of 0 to 2, with a maximum total score of 10: Score 7-10: Generally considered normal; indicates that the newborn is in good health. Score 4-6: Fairly low; may require some medical intervention such as oxygen or physical stimulation. Score 0-3: Critically low; requires immediate resuscitation and medical attention.
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 5
Weight (in grams)
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 6
Height (centimeters)
Time frame: 1 week after birth collected retrospectively
Neonatal outcomes 7
Head circumference (centimeters)
Time frame: 1 week after birth collected retrospectively
Birth outcomes 1
Type of birth. Measures in normal vaginal birth, instrumental birth and caesarian section.
Time frame: 1 week after birth collected retrospectively
Birth outcomes 2
State of the perineum after delivery: Measured in intact perineum, I degree tear, II degree tear, III degree tear, IV degree tear and episiotomy.
Time frame: 1 week after birth collected retrospectively
Birth outcomes 3
Type of analgesia during delivery: measured in epidural (yes/no), raquideal (yes/no), local (yes/no), and general (yes/no)
Time frame: 1 week after birth collected retrospectively
Birth outcomes 4
Labor induction: Descriptive yes/no
Time frame: 1 week after birth collected retrospectively
Birth outcomes 5
Maternal complications at birth (descriptive: admission to the ICU, obstetric emergency)
Time frame: 1 week after birth collected retrospectively
Biomarkers 1 (stress)
Maternal heart rate variability (HRV) Heart rate: Minimum Value: Varies depending on the individual's baseline, but generally, a healthy resting heart rate for adults ranges from 60 to 100 beats per minute (bpm). Maximum Value: This can vary widely based on activity and stress levels, but for pregnant women, a heart rate consistently above 100 bpm at rest might be concerning Maternal heart rate variability (HRV) refers to the variation in time intervals between heartbeats, which is a marker of autonomic nervous system function. Minimum Value: HRV does not have a fixed minimum value, but lower HRV generally indicates reduced autonomic flexibility and poor cardiovascular health. Maximum Value: Similarly, there is no fixed maximum value, but higher HRV is generally associated with better cardiovascular fitness and autonomic regulation.
Time frame: From 12 weeks of pregnancy until 2 years postpartum
Biomarkers 2 (sleep)
Sleeping patterns (measured with wearable): Key Metrics Monitored by Wearable: Sleeping patterns refer to the habitual sleep behaviors of an individual. Bed time start (date and time), bed time end (date and time) and awake time (in minutes) will be combined to report total sleep (in minutes). The overall of this metrics will give a score for sleeping patterns. Higher levels mean higher levels of resting.
Time frame: From 12 weeks of pregnancy until 2 years postpartum
Biomarkers 3 (activity)
Level of physical activity (measured with wearable): The heart rate monitor of the wearable measures the wearer's heart rate to gauge intensity of physical activity. The amount of time (in minutes) will give us the time a day spent in physical activities of moderate or higher intensity (HR\>100bpm). Higher levels mean higher levels of physical activity.
Time frame: From 12 weeks of pregnancy until 2 years postpartum
Child neurodevelopment
Ages and Stages Questionnaires (ASQ): This evaluation tool measures child development in areas such as communication, social behavior, motor coordination, language, and learning. The ASQ consists of different questionnaires adapted to different ages, which are completed by parents or caregivers. The results are used to identify children with potential developmental delays and provide early interventions to improve their cognitive and emotional health. The ASQ is widely used in clinical practice and research in the field of child development. Scores vary across different developmental domains: Communication, Social Behavior, Motor Coordination, Language, Learning. Higher scores: Indicate better developmental outcomes .
Time frame: 6 months, 12 months and 24 months postpartum.
Child neurodevelopment
The Bayley Scales of Infant and Toddler Development, commonly referred to as the Bayley Scales, is a standardized assessment tool used to evaluate the developmental functioning of infants and toddlers, typically from 1 month to 42 months of age. The Bayley Scales consist of five key domains, each designed to measure different aspects of a child's development: cognitive, language, motor, social-emotional and adaptive behaviour. The result is presented in percentiles (0-100) Higher scores: Indicate better developmental outcomes.
Time frame: 4 months and 24 months postpartum.
Adaptative behaviour
Vineland III: This evaluation tool is designed to measure adaptive skills in individuals of all ages, from infancy to adulthood. Scores vary across different subscales: Communication Skills, Social Skills, Daily Living Skills. Higher scores: Indicate better adaptive functioning.
Time frame: 4 months and 24 months postpartum.
Breastfeeding outcomes
Type of breastfeeding at discharge from hospital. Descriptive outcome reported as exclusive breastfeeding, mixed feeding or artificial feeding.
Time frame: 1 week after birth collected retrospectively
Breastfeeding outcomes
Breastfeeding duration (measured in days)
Time frame: Postpartum: 4 months, 1 year after childbirth collected retrospectively
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