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Kogito: App to Reduce Perinatal Psychosocial Stress

Primary Purpose

Psychological Stress, Perinatal Problems, Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Kogito
Sponsored by
National Institute of Mental Health, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • National Institute of Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

Usual care group - clinical

Usual care group - general

Kogito - clinical

Kogito - general

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

Change in subjective depression symptoms severity
measured by the Edinburgh Perinatal Depression Scale

Secondary Outcome Measures

Change in subjective anxiety symptoms severity
measured by the Perinatal Anxiety Screening scale
Change in subjective health related quality of life
measured by the Assessment of Quality of Life - eight dimensions scale
Change in subjective loneliness severity
measured by the UCLA Loneliness scale 3

Full Information

First Posted
May 2, 2021
Last Updated
August 30, 2021
Sponsor
National Institute of Mental Health, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04876144
Brief Title
Kogito: App to Reduce Perinatal Psychosocial Stress
Official Title
You Are Not Alone: a Mobile Application to Reduce Psychosocial Stress
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: complete survey questions at entrance into the study use the kogito app complete survey questions one month after study entrance Participants in the control group will be asked to do following things: complete survey questions at entrance into the study 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: complete survey questions at entrance into the study use the kogito app complete survey questions one month after study entrance Participants in the control group will be asked to do following things: complete survey questions at entrance into the study complete survey questions one month after study entrance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Perinatal Problems, Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care group - clinical
Arm Type
No Intervention
Arm Description
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.
Arm Title
Usual care group - general
Arm Type
No Intervention
Arm Description
Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Arm Title
Kogito - clinical
Arm Type
Experimental
Arm Description
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.
Arm Title
Kogito - general
Arm Type
Experimental
Arm Description
Usual prenatal/postpartum care plus use of the Kogito app.
Intervention Type
Device
Intervention Name(s)
Kogito
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in subjective depression symptoms severity
Description
measured by the Edinburgh Perinatal Depression Scale
Time Frame
Baseline to 1 month after study enrollment
Secondary Outcome Measure Information:
Title
Change in subjective anxiety symptoms severity
Description
measured by the Perinatal Anxiety Screening scale
Time Frame
Baseline to 1 month after study enrollment
Title
Change in subjective health related quality of life
Description
measured by the Assessment of Quality of Life - eight dimensions scale
Time Frame
Baseline to 1 month after study enrollment
Title
Change in subjective loneliness severity
Description
measured by the UCLA Loneliness scale 3
Time Frame
Baseline to 1 month after study enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavla Spadova
Phone
+420 283 088 436
Email
pavla.spadova@nudz.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonin Sebela, MD, PhD
Organizational Affiliation
National Institute of Mental Health, Klecany, Czechia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Mental Health
City
Klecany
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonin Sebela

12. IPD Sharing Statement

Plan to Share IPD
No

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Kogito: App to Reduce Perinatal Psychosocial Stress

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