Kogito: App to Reduce Perinatal Psychosocial Stress

National Institute of Mental Health, Czech Republic

Status: Unknown

Conditions: Perinatal Problems; Psychological Stress; Depression, Anxiety

Treatments: Device: Kogito

Study type: Interventional

Funder types: Other

Identifiers

NCT04876144

TL04000197

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18 or older
• pregnant women to 1 year after childbirth
• speak, read, and understand Czech
• signing of informed consent to the study and the GDPR form
• participant owns a smart phone and has access to the internet access plus for the clinical group:
• participant is undergoing the usual psychiatric care of the perinatal outpatient clinic of the National Institute of Mental Health, Czechia.

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Usual care group - clinical

No Intervention group

Description:

Usual prenatal and postpartum psychiatric care involves regular visits with a psychiatrist from the perinatal psychiatric outpatient clinic of the National Institute of Mental Health, Czechia.

Usual care group - general

No Intervention group

Description:

Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.

Kogito - clinical

Experimental group

Description:

Usual prenatal and postpartum psychiatric care in perinatal psychiatric outpatient clinic of the National Institute of the National Institute of Mental Health, Czechia plus use of the Kogito app.

Treatment:

Device: Kogito

Kogito - general

Experimental group

Description:

Usual prenatal/postpartum care plus use of the Kogito app.

Treatment:

Device: Kogito