NCT04876144

Kogito: App to Reduce Perinatal Psychosocial Stress

You Are Not Alone: a Mobile Application to Reduce Psychosocial Stress

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Institute of Mental Health, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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: 1:1 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: 1:1 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

Conditions

• Psychological Stress
• Perinatal Problems
• Depression, Anxiety

Interventions

Type	Name	Description
DEVICE	Kogito	Users of the Kogito app progress throught the deep self-help intervention in a sequence of 5 modules. The base of the Kogito app is in the cognitive-behavioral therapy (CBT), relaxation techniques and peer support. Module 1. Introduction to the CBT (psychoeducation) and deep breathing relaxation plus perinatal peer support videos. Emotional tracking. 2. Behavioral activization, relaxation techniques, CBT diary, psychoeducation on anxiety and depression, peer support. 3. CBT - vicious circle, progressive muscle relaxation, peer support content 4. Cognitive distortions, relaxation in imagination, peer support content 5. Cognitive restructuring, mindfulness relaxation, peer support content. Progress in the Kogito app is conditional on the completion of various CBT tasks

Timeline

• Start date: 2021-07-28
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-05-06
• Last updated: 2021-08-31

Locations

1 site across 1 country: Czechia