Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610552
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
POWERLY app
Brief Summary:
The goal of this clinical trial is to determine if the Powerly app can help prevent postpartum depression and anxiety in healthy pregnant women
The main questions it aims to answer are
Does the Powerly app reduce postpartum depression and anxiety
Does it improve emotion regulation and maternal bonding with a child
Researchers will compare two groups one using the Powerly app and the other receiving care as usual CAU to see if the app leads to better mental health outcomes
Participants will
Use the Powerly app for four weeks if in the intervention group
Complete mental health assessments before the study after four weeks and six weeks postpartum
The main questions it aims to answer are
Does the Powerly app reduce postpartum depression and anxiety
Does it improve emotion regulation and maternal bonding with a child
Researchers will compare two groups one using the Powerly app and the other receiving care as usual CAU to see if the app leads to better mental health outcomes
Participants will
Use the Powerly app for four weeks if in the intervention group
Complete mental health assessments before the study after four weeks and six weeks postpartum
Detailed Description:
Pregnancy is a period of significant emotional and physical changes with up to 30 of expecting mothers experiencing high stress After birth around 15-20 of new mothers suffer from postpartum depression and 25-35 experience anxiety Despite broad availability of mobile apps aimed at these challenges none of them have been rigorously tested through clinical studies To fill this gap we developed Powerly a science-based mobile app designed to help prevent postpartum depression and anxiety
In this study 140 healthy pregnant women will be randomly assigned to one of two groups one will use the Powerly app for four weeks while the other will receive care as usual CAU Powerly is grounded in cognitive behavioral therapy CBT and personalized to the individuals needs with input from healthcare professionals and pregnant women We will collect information on participants39 mental health at three points before they start using the app after four weeks of app use CAU and six weeks after giving birth The apps effectiveness will be evaluated by examining improvements in mental health outcomes such as reduced rates of postpartum depression and anxiety better emotion regulation and stronger maternal bonding with a baby
In this study 140 healthy pregnant women will be randomly assigned to one of two groups one will use the Powerly app for four weeks while the other will receive care as usual CAU Powerly is grounded in cognitive behavioral therapy CBT and personalized to the individuals needs with input from healthcare professionals and pregnant women We will collect information on participants39 mental health at three points before they start using the app after four weeks of app use CAU and six weeks after giving birth The apps effectiveness will be evaluated by examining improvements in mental health outcomes such as reduced rates of postpartum depression and anxiety better emotion regulation and stronger maternal bonding with a baby
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