NCT02637414

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

December 11, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

December 11, 2015

Last Update Submit

June 20, 2017

Conditions

Emotional Stress

Keywords

StressWell-beingPositive psychology

Outcome Measures

Primary Outcomes (2)

  • Changes in subjective symptoms of well-being at work

    Sliding scale for stress level from 0 to 100

    baseline, 4 weeks, 8 weeks

  • Changes in subjective symptoms of stress

    Sliding scale for well-being level from 0 to 100

    baseline, 4 weeks, 8 weeks

Secondary Outcomes (2)

  • Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress

    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

    four times a week, before and after the period of each class (20 min)

Study Arms (2)

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.

Behavioral: Flourishing App Program

Interventions

Flourishing App ProgramBEHAVIORAL

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.

Flourishing App Program

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female aging from 18 to 60
  • Complete higher education
  • Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31697244DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Elisa H Kozasa, PhD

    Instituto do Cérebro- Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 11, 2015

First Posted

December 22, 2015

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations

BR(1)