Emotional StressNCT02637414
Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices
A study testing Flourishing App Program in people with Emotional Stress, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Flourishing App Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Jun 2017
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aging from 18 to 60
- Complete higher education
- Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).
Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution.
Read the detailed description
Introduction: Stress related disorders may result in absenteeism and less productivity in companies. This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. In the modern world not all people are willing to attend classroom training for several reasons. In this sense, the investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).
Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution. The GI will participate in the Flourishing App Program, for eight weeks, while the GC will have access to a Control App. Then, after the evaluations, the GC will receive the intervention (Flourishing App Program), while the first group will not receive any intervention. Questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.
- Conditions
- Emotional Stress
- Being tested
- Flourishing App Program
- Keywords
- Stress, Well-being, Positive psychology
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourishing App ProgramBehavioural
This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices. It will last for 8 weeks, with trainings of 15 to 25 minutes, four times a week.
| Study group | Role | What they receive |
|---|---|---|
| Control App | No intervention | Initially this control group will have access to a Control App and after 8 weeks this goup will receive the intervention (Flourishing App Program). |
| Flourishing App Program | Experimental | This group will receive the intervention Flourishing App Program and after that it will not receive any other intervention. Receives: Behavioral: Flourishing App Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective symptoms of well-being at work
Sliding scale for stress level from 0 to 100
Measured: baseline, 4 weeks, 8 weeks
Changes in subjective symptoms of stress
Sliding scale for well-being level from 0 to 100
Measured: baseline, 4 weeks, 8 weeks
Secondary outcomes (2)
Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress
Sliding scale for stress level from 0 to 100
Measured: four times a week, before and after the period of each class (20 min)
Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being
Sliding scale for well-being level from 0 to 100
Measured: four times a week, before and after the period of each class (20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Kozasa, Hospital Israelita Albert Einstein
- Investigators
- Elisa H Kozasa, PhD, Principal investigator, Instituto do Cérebro- Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637414
- Sponsor's protocol ID
- HIAE_App Florescer
- Status last verified
- Jun 2017
- First submitted
- 11 Dec 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coelhoso CC, Tobo PR, Lacerda SS, Lima AH, Barrichello CRC, Amaro E Jr, Kozasa EH. A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 7;21(11):e14269. doi: 10.2196/14269.
PubMed 31697244
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices
- ClinicalTrials.gov ID
- NCT02637414
- Acronym / sponsor ID
- HIAE_App Florescer
- Conditions
- Emotional Stress
- Keywords
- Stress, Well-being, Positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- 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.
This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).
Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution.
Detailed description
Introduction: Stress related disorders may result in absenteeism and less productivity in companies. This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. In the modern world not all people are willing to attend classroom training for several reasons. In this sense, the investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).
Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution. The GI will participate in the Flourishing App Program, for eight weeks, while the GC will have access to a Control App. Then, after the evaluations, the GC will receive the intervention (Flourishing App Program), while the first group will not receive any intervention. Questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control App | No intervention | –Initially this control group will have access to a Control App and after 8 weeks this goup will receive the intervention (Flourishing App Program). |
| Flourishing App Program | Experimental | Behavioral: Flourishing App ProgramThis group will receive the intervention Flourishing App Program and after that it will not receive any other intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female aging from 18 to 60
- Complete higher education
- Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein
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 |
|---|---|---|
| Flourishing App ProgramThis intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices. It will last for 8 weeks, with trainings of 15 to 25 minutes, four times a week. | Behavioural | Flourishing App Program |
Primary outcome
Changes in subjective symptoms of well-being at work
Time frame: baseline, 4 weeks, 8 weeks
Sliding scale for stress level from 0 to 100
Changes in subjective symptoms of stress
Time frame: baseline, 4 weeks, 8 weeks
Sliding scale for well-being level from 0 to 100
2 secondary outcomes
Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress
Time frame: four times a week, before and after the period of each class (20 min)
Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being
Time frame: four times a week, before and after the period of each class (20 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Derived from this study: PubMed 31697244Coelhoso CC, Tobo PR, Lacerda SS, Lima AH, Barrichello CRC, Amaro E Jr, Kozasa EH. A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 7;21(11):e14269. doi: 10.2196/14269.
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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.
Elisa H Kozasa, PhD principal investigator
Instituto do Cérebro- Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourishing App Program in people with Emotional Stress, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 22 Jun 2017. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subjective symptoms of well-being at work (time frame: baseline, 4 weeks, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637414, which also lists 1 linked publication.
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 22 Jun 2017.