MamaConecta: Digital Tool for Maternal Mental Health
- Conditions
- Postpartum DepressionMental Health IssueWell-Being, PsychologicalPregnancy RelatedPostpartum Anxiety
- Interventions
- Other: Monitoring via wearableOther: Mobile application
- Registration Number
- NCT06442774
- Lead Sponsor
- A Thousand Colibris, S.L
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1200
- Gestational age between 12-14 weeks of gestation.
- The first obstetric ultrasound has been performed.
- Women who know how to read and understand Spanish.
- Women who have access to a mobile phone with an internet connection (data or wifi)
- Women who have knowledge of technology tools via app.
- Have signed the informed consent to participate in the study.
- Termination of pregnancy, or early miscarriage
- Perinatal loss at any time during pregnancy.
- Severe mental pathology or moderate unstable mental pathology.
- Consumption of toxic substances.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Monitoring via wearable Participants of this group will have care as usual from healthcare providers. Participants will have the study variables measured (by questionnaires and monitoring via wearable). Mobile application Mobile application Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable) Mobile application Monitoring via wearable Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable)
- Primary Outcome Measures
Name Time Method Maternal well-being 12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum. 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.
- Secondary Outcome Measures
Name Time Method Depression 12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum. 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.Anxiety 12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum. 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.Birth Fear 12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum. 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.Maternal Antenatal attachment 29-30 weeks of pregnancy. 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.Bonding 6 weeks, 6, 12, 24 months postpartum. 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.Birth Experience 33-34 weeks of pregnancy, 6 weeks postpartum. Using the Mackey Satisfaction Childbirth Questionnaire to measure childbirth satisfaction.
Min value: 11 Max value: 55 Higher scores: Indicate higher satisfaction.Traumatic stress responses related to childbirth 6 weeks postpartum 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.Health costs 1 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period. 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.Health costs 2 1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period. Duration of hospital admission (measured in days).
Higher values: Indicate higher expenses for the healthcare system.Parental stress 6, 12, 24 months postpartum. 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.Sleep 12-14 and 33-34 weeks of pregnancy 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.Neonatal outcomes 1 1 week after birth collected retrospectively Gestational age at delivery (weeks+days) Normal range: 37-42 weeks Lower values: Indicate preterm newborns. Higher values: Indicate postterm newborns.
Neonatal outcomes 3 1 week after birth collected retrospectively Neonatal complications at birth (descriptive: admission to the ICU, neonatal sepsis)
Neonatal outcomes 6 1 week after birth collected retrospectively Height (centimeters)
Neonatal outcomes 7 1 week after birth collected retrospectively Head circumference (centimeters)
Birth outcomes 1 1 week after birth collected retrospectively Type of birth. Measures in normal vaginal birth, instrumental birth and caesarian section.
Birth outcomes 2 1 week after birth collected retrospectively State of the perineum after delivery: Measured in intact perineum, I degree tear, II degree tear, III degree tear, IV degree tear and episiotomy.
Birth outcomes 4 1 week after birth collected retrospectively Labor induction: Descriptive yes/no
Maternal empowerment Postpartum: 6 weeks and 24 months 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.Physical Activity 12-14 and 33-34 weeks of pregnancy. 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.Pregnancy outcomes 1 week after birth collected retrospectively for pregnancy and childbirth 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.Neonatal outcomes 2 1 week after birth collected retrospectively 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.Neonatal outcomes 5 1 week after birth collected retrospectively Weight (in grams)
Birth outcomes 3 1 week after birth collected retrospectively Type of analgesia during delivery: measured in epidural (yes/no), raquideal (yes/no), local (yes/no), and general (yes/no)
Biomarkers 1 (stress) From 12 weeks of pregnancy until 2 years postpartum 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.Breastfeeding outcomes Postpartum: 4 months, 1 year after childbirth collected retrospectively Breastfeeding duration (measured in days)
Neonatal outcomes 4 1 week after birth collected retrospectively 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.Biomarkers 3 (activity) From 12 weeks of pregnancy until 2 years postpartum 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.Biomarkers 2 (sleep) From 12 weeks of pregnancy until 2 years postpartum 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.Birth outcomes 5 1 week after birth collected retrospectively Maternal complications at birth (descriptive: admission to the ICU, obstetric emergency)
Child neurodevelopment 4 months and 24 months postpartum. 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.Adaptative behaviour 4 months and 24 months postpartum. 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.
Trial Locations
- Locations (3)
Hospital Vall d'Hebron
🇪🇸Barcelona, Catalunya, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
ASSIR Tarragona
🇪🇸Tarragona, Spain