NCT04876144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 31, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

May 2, 2021

Last Update Submit

August 30, 2021

Conditions

Psychological StressPerinatal ProblemsDepression, Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in subjective depression symptoms severity

    measured by the Edinburgh Perinatal Depression Scale

    Baseline to 1 month after study enrollment

Secondary Outcomes (3)

  • Change in subjective anxiety symptoms severity

    Baseline to 1 month after study enrollment

  • Change in subjective health related quality of life

    Baseline to 1 month after study enrollment

  • Change in subjective loneliness severity

    Baseline to 1 month after study enrollment

Study Arms (4)

Usual care group - clinical

NO INTERVENTION

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 care group - general

NO INTERVENTION

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

Kogito - clinical

EXPERIMENTAL

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

Kogito - general

EXPERIMENTAL

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

Device: Kogito

Interventions

KogitoDEVICE

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 1. Introduction to the CBT (psychoeducation) and deep breathing relaxation plus perinatal peer support videos. Emotional tracking. 2. Behavioral activization, relaxation techniques, CBT diary, psychoeducation on anxiety and depression, peer support. 3. CBT - vicious circle, progressive muscle relaxation, peer support content 4. Cognitive distortions, relaxation in imagination, peer support content 5. Cognitive restructuring, mindfulness relaxation, peer support content. Progress in the Kogito app is conditional on the completion of various CBT tasks

Kogito - clinicalKogito - general

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health

Klecany, Czechia

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Antonin Sebela, MD, PhD

    National Institute of Mental Health, Klecany, Czechia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavla Spadova

CONTACT

+420 283 088 436pavla.spadova@nudz.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 6, 2021

Study Start

July 28, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 31, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)