The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program

NCT02164188 | Completed DMC

• 1 other identifier: HIAE_Florescer
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol proposes a well-being program 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 may promote well-being and reduce stress related problems in the participants. Objectives: To evaluate the efficacy of a well-being program in a sample of managers who work in a company (Natura Inovação/Cosméticos ) and health care professionals who work in a hospital (Hospital Israelita Albert Einstein) as well as its implication in the work environment. Methods: Sixty managers from Natura Inovação/Cosméticos and 60 health professionals from Hospital Israelita Albert Einstein 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).

Conditions

Emotional Stress

Keywords

Stress; Well-being; Functional magnetic resonance imaging; Positive psychology

Outcome Measures

Primary Outcomes (2)

• Change in perceived stress

  Lipp Stress Inventory; Perceived Stress Scale

  (baseline, 3 months, 6 months)

• Changes in well-being

  WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.

  baseline, 3 months, 6 months

Secondary Outcomes (1)

• Change in cortisol levels

  Baseline; 3 months; after 6 months

Other Outcomes (6)

• Changes in brain function

  Baseline; 3 months; 6 months

• Changes in anxiety symptoms

  baseline, 3 months,6 months

• Changes in depression symptoms

  baseline, 3 months, 6 months

Study Arms (2)

control

NO INTERVENTION

Initially this control group will not receive an intervention (wait list). After 8 weeks this goup will receive the Flourishing protocol (cross over).

Flourishing protocol

EXPERIMENTAL

This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).

Behavioral: Flourishing protocol

Interventions

Flourishing protocol BEHAVIORAL

This intervention is based on relaxation, well-being promotion, meditation practices, positive psychology principles. The format is 1hour and half meetings during 8 weeks, and daily practices. MP3 audios are presented for daily practices.

Flourishing protocol

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female aging from 25 to 60
• Managers from Natura Company or healthcare professionals from Hospital Israelita Albert Einstein

You may not qualify if:

• Sever mental or physical diseases
• For fMRI we will exclude participants who don´t match the criteria to undergoing this exam.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

Related Links

• A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients.
• Meditation training increases brain efficiency in an attention task.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: June 16, 2014
• Study Start: April 3, 2014
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

BR (1)