Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640907
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders As Normalized Routine Practice e-Perinatal Pilot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation As Normalized Routine Practice e-Perinatal Pilot Randomized Control Trial WP2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is part of the e-Perinatal project funded by the European Research Council This research project will follow the first three phases recommended by the Medical Research Council MRC framework for the development and evaluation of complex interventions Skivington et al 2021
This study aims to evaluate the feasibility and acceptability of implementing an innovative personalized mobile health mHealth intervention designed to prevent maternal perinatal mental health disorders Using a pilot cluster-randomized hybrid type 1 clinical trial the study will explore key implementation aspects and preliminary data of interventions effectiveness This study will set the groundwork for a future full clinical trial intending to test the effectiveness of a personalized mHealth intervention for enhancing overall perinatal mental health and its implementation into routine prenatal and postnatal maternal health care
This study aims to evaluate the feasibility and acceptability of implementing an innovative personalized mobile health mHealth intervention designed to prevent maternal perinatal mental health disorders Using a pilot cluster-randomized hybrid type 1 clinical trial the study will explore key implementation aspects and preliminary data of interventions effectiveness This study will set the groundwork for a future full clinical trial intending to test the effectiveness of a personalized mHealth intervention for enhancing overall perinatal mental health and its implementation into routine prenatal and postnatal maternal health care
Detailed Description:
This pilot clinical study investigates the feasibility and acceptability of a cluster-randomized hybrid type 1 clinical trial aiming to assess the implementation and potential effectiveness of an innovative personalized mobile health mHealth intervention -the e-Perinatal App- for the prevention of maternal perinatal mental health disorders within primary care settings The primary objective is to evaluate the feasibility of integrating this app into routine prenatal and postnatal care enhancing maternal mental health outcomes during the perinatal period The participants will be women during the perinatal period and their partners
Specific objectives of the study include
1 To assess the acceptability of the e-Perinatal App
2 To evaluate the preliminary effectiveness of the intervention in reducing the incidence of depression and anxiety in women alleviating depressive and anxious symptoms in their partners and promoting infant health and development
3 To assess aspect related with evaluation design
The study hypothesizes that the personalized e-Perinatal mHealth intervention will be both feasible and acceptable to pregnant and new mothers their partners and healthcare professionals involved in routine prenatal and postnatal maternal health care
Participants ie pregnant or postpartum women and their partners will be recruited from primary care settings They will be clustered and assigned to either the intervention group which will receive the e-Perinatal personalized mHealth intervention or the control group which will continue with usual care
Specific objectives of the study include
1 To assess the acceptability of the e-Perinatal App
2 To evaluate the preliminary effectiveness of the intervention in reducing the incidence of depression and anxiety in women alleviating depressive and anxious symptoms in their partners and promoting infant health and development
3 To assess aspect related with evaluation design
The study hypothesizes that the personalized e-Perinatal mHealth intervention will be both feasible and acceptable to pregnant and new mothers their partners and healthcare professionals involved in routine prenatal and postnatal maternal health care
Participants ie pregnant or postpartum women and their partners will be recruited from primary care settings They will be clustered and assigned to either the intervention group which will receive the e-Perinatal personalized mHealth intervention or the control group which will continue with usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None