Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442774
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-14
Brief Title:
MamaConecta Digital Tool for Maternal Mental Health
Sponsor:
A Thousand Colibris SL
Organization:
A Thousand Colibris SL
Study Overview
Official Title:
Digital Tool to Improve Maternal Mental Health Enhancing Well-being Early Detection Diagnosis Support and Monitoring of Mental Health Problems During the Perinatal Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DDT
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 dHebron 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 Governments Scientific Technical and Innovation Research Plan 2021-2023
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 dHebron 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 Governments Scientific Technical and Innovation Research Plan 2021-2023
Detailed Description:
BACKGROUND
Mental disorders are becoming one of the major health problems in todays 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 SL 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 mothers 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 childs development
3 Impact on family well-being The mothers 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 httpwwwconsortstatementorg and the Standard Protocol Items Recommendations for Interventional Trials SPIRIT
2 Participants The study will be conducted at Vall dHebrón 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 005 and a beta risk error of 02 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 186 points assuming a standard deviation of 207 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 206 points assuming a standard deviation of 190 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 213 points assuming a standard deviation of 246 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 554 points assuming a standard deviation of 45 points Thus 64 subjects per arm are needed so a total sample of 300 pregnant women per center should be recruited
4 Procedures
41 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
42 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
43 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
44 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 centers 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
Mental disorders are becoming one of the major health problems in todays 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 SL 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 mothers 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 childs development
3 Impact on family well-being The mothers 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 httpwwwconsortstatementorg and the Standard Protocol Items Recommendations for Interventional Trials SPIRIT
2 Participants The study will be conducted at Vall dHebrón 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 005 and a beta risk error of 02 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 186 points assuming a standard deviation of 207 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 206 points assuming a standard deviation of 190 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 213 points assuming a standard deviation of 246 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 554 points assuming a standard deviation of 45 points Thus 64 subjects per arm are needed so a total sample of 300 pregnant women per center should be recruited
4 Procedures
41 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
42 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
43 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
44 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 centers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None