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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.
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:
Participants in the control group will be asked to do following things:
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:
Participants in the control group will be asked to do following things:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care group - clinical | No Intervention | 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 | 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 | 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. |
|
| Kogito - general | Experimental | Usual prenatal/postpartum care plus use of the Kogito app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kogito | Device | 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
Progress in the Kogito app is conditional on the completion of various CBT tasks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective depression symptoms severity | measured by the Edinburgh Perinatal Depression Scale | Baseline to 1 month after study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective anxiety symptoms severity | measured by the Perinatal Anxiety Screening scale | Baseline to 1 month after study enrollment |
| Change in subjective health related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavla Spadova | Contact | +420 283 088 436 | pavla.spadova@nudz.cz |
| Name | Affiliation | Role |
|---|---|---|
| Antonin Sebela, MD, PhD | National Institute of Mental Health, Klecany, Czechia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Mental Health | Recruiting | Klecany | Czechia |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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measured by the Assessment of Quality of Life - eight dimensions scale
| Baseline to 1 month after study enrollment |
| Change in subjective loneliness severity | measured by the UCLA Loneliness scale 3 | Baseline to 1 month after study enrollment |