Kogito: App to Reduce Perinatal Psychosocial Stress

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression, Anxiety; Psychological Stress; Perinatal Problems
• Intervention / Treatment: Device: Kogito

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Klecany, Czechia
    • Recruiting
    • National Institute of Mental Health
    • Contact: Antonin Sebela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	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
EXPERIMENTAL: Kogito - general; Usual prenatal/postpartum care plus use of the Kogito app.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective depression symptoms severity	measured by the Edinburgh Perinatal Depression Scale	Baseline to 1 month after study enrollment

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Institute of Mental Health, Czech Republic
• Investigators: Principal Investigator: Antonin Sebela, MD, PhD, National Institute of Mental Health, Klecany, Czechia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (ACTUAL): May 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: TL04000197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No