Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876144
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2021-05-02
Brief Title:
Kogito App to Reduce Perinatal Psychosocial Stress
Sponsor:
National Institute of Mental Health Czech Republic
Organization:
National Institute of Mental Health Czech Republic
Study Overview
Official Title:
You Are Not Alone a Mobile Application to Reduce Psychosocial Stress
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this research study is to test the efectivness of the remote solution for psychosocial stress in pregnant women and postpartum women Based on the connection of know-how in the field of social sciences and humanities psychology volunteer community and peer work with target group and technological know-how software design and development investigators developed an interactive intervention software Kogito app to reduce psychosocial stress in the target group
Detailed Description:
This study examine the potential of Kogito app in the delivery of mental and social support care to pregnant and postpartum women using psychometric methods
A Clinical efficacy of Kogito app in a clinical cohort Sample pregnant or postpartum women with who are being treated in the psychiatric perinatal outpatient clinic of the National Institute of Mental Health Czech Republic The app will be tested as a add-on method of care
Intervention group Kogito app is added to the usual care Control group usual care Randomization 11
Participants in the intervention group will be asked to do following things
1 complete survey questions at entrance into the study
2 use the kogito app
3 complete survey questions one month after study entrance
Participants in the control group will be asked to do following things
1 complete survey questions at entrance into the study
2 complete survey questions one month after study entrance
B Clinical efficacy of the Kogito app in a general cohort The app will be offered free of charge to users from the population of pregnant and postpartum women for the duration of the study
Recruitment method advertisements on social networks of National Institute of Mental Health and other public media in Czechia Sample pregnant or postpartum women from general population in Czechia The app will be tested using the waiting list as a control condition
Intervention group Kogito app Control group one month waiting list Randomization 11
Participants in the intervention group will be asked to do following things
1 complete survey questions at entrance into the study
2 use the kogito app
3 complete survey questions one month after study entrance
Participants in the control group will be asked to do following things
1 complete survey questions at entrance into the study
2 complete survey questions one month after study entrance
A Clinical efficacy of Kogito app in a clinical cohort Sample pregnant or postpartum women with who are being treated in the psychiatric perinatal outpatient clinic of the National Institute of Mental Health Czech Republic The app will be tested as a add-on method of care
Intervention group Kogito app is added to the usual care Control group usual care Randomization 11
Participants in the intervention group will be asked to do following things
1 complete survey questions at entrance into the study
2 use the kogito app
3 complete survey questions one month after study entrance
Participants in the control group will be asked to do following things
1 complete survey questions at entrance into the study
2 complete survey questions one month after study entrance
B Clinical efficacy of the Kogito app in a general cohort The app will be offered free of charge to users from the population of pregnant and postpartum women for the duration of the study
Recruitment method advertisements on social networks of National Institute of Mental Health and other public media in Czechia Sample pregnant or postpartum women from general population in Czechia The app will be tested using the waiting list as a control condition
Intervention group Kogito app Control group one month waiting list Randomization 11
Participants in the intervention group will be asked to do following things
1 complete survey questions at entrance into the study
2 use the kogito app
3 complete survey questions one month after study entrance
Participants in the control group will be asked to do following things
1 complete survey questions at entrance into the study
2 complete survey questions one month after study entrance
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