Psychological StressNCT04876144
Kogito: App to Reduce Perinatal Psychosocial Stress
A study testing Kogito in people with Psychological Stress and Perinatal Problems, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Perinatal Problems, Depression, Anxiety
- What is being tested?
- Kogito
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Jul 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
National Institute of Mental Health
Klecany
Antonin Sebela
About this study
Official title: 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.
Read the 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.
- 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
- 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
- Being tested
- Kogito
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Kogito |
| Kogito - general | Experimental | Usual prenatal/postpartum care plus use of the Kogito app. Receives: Device: Kogito |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective depression symptoms severity
measured by the Edinburgh Perinatal Depression Scale
Measured: Baseline to 1 month after study enrollment
Secondary outcomes (3)
Change in subjective anxiety symptoms severity
measured by the Perinatal Anxiety Screening scale
Measured: 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
Measured: Baseline to 1 month after study enrollment
Change in subjective loneliness severity
measured by the UCLA Loneliness scale 3
Measured: Baseline to 1 month after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start28 Jul 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonin Sebela, MD, PhD, Principal investigator, National Institute of Mental Health, Klecany, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876144
- Sponsor's protocol ID
- TL04000197
- Status last verified
- Apr 2021
- First submitted
- 2 May 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You Are Not Alone: a Mobile Application to Reduce Psychosocial Stress
- ClinicalTrials.gov ID
- NCT04876144
- Acronym / sponsor ID
- TL04000197
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: KogitoUsual 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. |
| Kogito - general | Experimental | Device: KogitoUsual prenatal/postpartum care plus use of the Kogito app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KogitoUsers 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 | Device | Kogito - clinical, Kogito - general |
Primary outcome
Change in subjective depression symptoms severity
Time frame: Baseline to 1 month after study enrollment
measured by the Edinburgh Perinatal Depression Scale
3 secondary outcomes
Change in subjective anxiety symptoms severity
Time frame: Baseline to 1 month after study enrollment
Change in subjective health related quality of life
Time frame: Baseline to 1 month after study enrollment
Change in subjective loneliness severity
Time frame: Baseline to 1 month after study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonin Sebela, MD, PhD principal investigator
National Institute of Mental Health, Klecany, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kogito in people with Psychological Stress and Perinatal Problems, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavla Spadova (+420 283 088 436, pavla.spadova@nudz.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective depression symptoms severity (time frame: Baseline to 1 month after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.