Emotional StressNCT03096171
Flourishing App: An Evaluation With High School Students
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 14 to 18 yearsHealthy 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
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Mar 2016to 31 Dec 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Complete elementary school
Who cannot join
- -
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 high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI).
Read the detailed description
Introduction: Some very successful stress management programs are based on the principle of Mindfulness. 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, young people are connected to new technologies and the use of applications can be a fun way to learn how to cope with stress and promote well-being. In this sense, the investigators hypothesize that this program offered in mobile application can be considered an interesting alternative for high school students who want to reduce symptoms related to stress and also promote well-being. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI). 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 repeat the use of the Flourishing App Program. 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 16 weeks, with trainings of 20 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 for 16 weeks. 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 stress in the last 30 days
Sliding scale for stress level from 0 to 100
Measured: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Changes in subjective symptoms of well-being in the last 30 days
Sliding scale for well-being level from 0 to 100
Measured: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary outcomes (2)
Changes in subjective symptoms of stress at the moment
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
Sliding scale for stress 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 posted30 Mar 2017
- Study start28 Mar 2016
- Primary completion28 Mar 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Behavioral: Flourishing App Program 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 16 weeks, with trainings of 20 minutes, four times a week. No Intervention: Control App This group will observe their psychological and physical condition (levels of stress and well-being) during their daily activities and social interactions for 8 weeks. After the evaluations, this group will receive the intervention (Flourishing App Program) for more 8 weeks.
- Masking
- None (open label)
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096171
- Sponsor's protocol ID
- HIAE_App Florescer_Alunos
- Status last verified
- Feb 2018
- First submitted
- 24 Mar 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flourishing App: An Evaluation With High School Students
- ClinicalTrials.gov ID
- NCT03096171
- Acronym / sponsor ID
- HIAE_App Florescer_Alunos
- Conditions
- Emotional Stress
- Keywords
- Stress, Well-being, Positive Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 30 Mar 2017 (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.
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 high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI).
Detailed description
Introduction: Some very successful stress management programs are based on the principle of Mindfulness. 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, young people are connected to new technologies and the use of applications can be a fun way to learn how to cope with stress and promote well-being. In this sense, the investigators hypothesize that this program offered in mobile application can be considered an interesting alternative for high school students who want to reduce symptoms related to stress and also promote well-being. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students. Methods: Sixty high school students will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI). 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 repeat the use of the Flourishing App Program. 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
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral: Flourishing App Program 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 16 weeks, with trainings of 20 minutes, four times a week. No Intervention: Control App This group will observe their psychological and physical condition (levels of stress and well-being) during their daily activities and social interactions for 8 weeks. After the evaluations, this group will receive the intervention (Flourishing App Program) for more 8 weeks.
| 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 for 16 weeks. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Complete elementary school
Key exclusion criteria (1 listed)
- -
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 16 weeks, with trainings of 20 minutes, four times a week. | Behavioural | Flourishing App Program |
Primary outcome
Changes in subjective symptoms of stress in the last 30 days
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Sliding scale for stress level from 0 to 100
Changes in subjective symptoms of well-being in the last 30 days
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Sliding scale for well-being level from 0 to 100
2 secondary outcomes
Changes in subjective symptoms of stress at the moment
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
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 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 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 Feb 2018. 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 stress in the last 30 days (time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 16 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?
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 Feb 2018.