Kogito: App to Reduce Perinatal Psychosocial Stress

Not Applicable

• Conditions: Psychological Stress; Perinatal Problems; Depression, Anxiety
• Interventions: Device: Kogito

• Registration Number: NCT04876144
• Lead Sponsor: National Institute of Mental Health, Czech Republic

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

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-06
• Study Start: 2021-07-28
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kogito - clinical	Kogito	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	Kogito	Usual prenatal/postpartum care plus use of the Kogito app.

Primary Outcome Measures

Name	Time	Method
Change in subjective depression symptoms severity	Baseline to 1 month after study enrollment	measured by the Edinburgh Perinatal Depression Scale

Secondary Outcome Measures

Name	Time	Method
Change in subjective anxiety symptoms severity	Baseline to 1 month after study enrollment	measured by the Perinatal Anxiety Screening scale
Change in subjective loneliness severity	Baseline to 1 month after study enrollment	measured by the UCLA Loneliness scale 3
Change in subjective health related quality of life	Baseline to 1 month after study enrollment	measured by the Assessment of Quality of Life - eight dimensions scale

Trial Locations

Locations (1)

National Institute of Mental Health; 🇨🇿 Klecany, Czechia