Clinical trial NCT04876144: Kogito: App to Reduce Perinatal Psychosocial Stress
Official title: You Are Not Alone: a Mobile Application to Reduce Psychosocial Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Stress
Perinatal Problems
Depression, Anxiety
Lead sponsor: National Institute of Mental Health, Czech Republic
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Change in subjective depression symptoms severity
timeFrame: Baseline to 1 month after study enrollment
Secondary outcomes:
measure: Change in subjective anxiety symptoms severity
timeFrame: Baseline to 1 month after study enrollment
measure: Change in subjective health related quality of life
timeFrame: Baseline to 1 month after study enrollment
measure: Change in subjective loneliness severity
timeFrame: Baseline to 1 month after study enrollment
Other outcomes:
Locations:
city: Klecany
country: Czechia
facility: National Institute of Mental Health
Study officials:
affiliation: National Institute of Mental Health, Klecany, Czechia
name: Antonin Sebela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: