Kogito: App to Reduce Perinatal Psychosocial Stress

NCT ID: NCT04876144

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2021-12-31

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: 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care group - clinical

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual care group - general

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Kogito - clinical

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.

Group Type: EXPERIMENTAL

Kogito

Intervention Type: 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

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

Kogito - general

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

Group Type: EXPERIMENTAL

Kogito

Intervention Type: 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

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonin Sebela, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health, Klecany, Czechia

Locations

National Institute of Mental Health

Klecany, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Pavla Spadova

Role: CONTACT

pavla.spadova@nudz.cz

+420 283 088 436

Facility Contacts

Antonin Sebela

Role: primary

Other Identifiers

TL04000197

Identifier Type: -

Identifier Source: org_study_id