Kogito: App to Reduce Perinatal Psychosocial Stress

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876144
• Other study ID #: TL04000197
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: National Institute of Mental Health, Czech Republic
• Contact: Pavla Spadova
• Phone: +420 283 088 436
• Email: pavla.spadova[@]nudz.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression, Anxiety
• Perinatal Problems
• Psychological Stress
• Stress, Psychological

Intervention

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 Introduction to the CBT (psychoeducation) and deep breathing relaxation plus perinatal peer support videos. Emotional tracking. Behavioral activization, relaxation techniques, CBT diary, psychoeducation on anxiety and depression, peer support. CBT - vicious circle, progressive muscle relaxation, peer support content Cognitive distortions, relaxation in imagination, peer support content Cognitive restructuring, mindfulness relaxation, peer support content. Progress in the Kogito app is conditional on the completion of various CBT tasks

Locations

Country	Name	City	State
Czechia	National Institute of Mental Health	Klecany

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective depression symptoms severity	measured by the Edinburgh Perinatal Depression Scale	Baseline to 1 month after study enrollment
Secondary	Change in subjective anxiety symptoms severity	measured by the Perinatal Anxiety Screening scale	Baseline to 1 month after study enrollment
Secondary	Change in subjective health related quality of life	measured by the Assessment of Quality of Life - eight dimensions scale	Baseline to 1 month after study enrollment
Secondary	Change in subjective loneliness severity	measured by the UCLA Loneliness scale 3	Baseline to 1 month after study enrollment