The combination of NEUROFEEDBACK by HEMOENCEPHALOGRAPHIC (HEG) and MINDFULNESS for the reduction of stress in the workplace: Randomized Clinical Trial.

• Grant number: 25/02251-8
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2025
• End date: April 30, 2026
• Field of knowledge: Health Sciences - Medicine - Psychiatry
• Principal Investigator: Eurípedes Constantino Miguel Filho
• Grantee: Nestor Sousa Junior
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated research grant: 21/12901-9 - National Center for Research and Innovation in Mental Health (CISM), AP.ESP

Abstract

The World Health Organization(WHO), in its report "Transforming Mental Health for All", underlines the need to address mental health issues such as stress, depression and anxiety in the workplace. Promoting employees' mental well-being not only improves the quality of life, but also increases productivity and economic results. Mental health problems are identified as major causes of global disability, resulting in insignificant loss of working days. Mindfulness-Based Interventions (IBMs) are highlighted by the WHO as effective methods to improve mental health, with Mindfulness being defined as mindfulness of the present moment without judgment, effective in reducing stress. IBM programs typically last eight weeks and include theoretical and practical content to incorporate meditation into your daily routine. Combining neuromeditation with HEG neurofeedback offers a promising approach to mental health. Studies indicate that these techniques can reduce stress and promote positive emotional states. A recent clinical trial showed that neurofeedback-assisted mindfulness training can reduce employee stress and improve resilience and relaxation, with lasting effects. The overall objective of this study is to compare the effects of a Mindfulness program guided by verum and sham Hemoencephalography Neurofeedback (HEG). Method: Randomized, double-blind, sham-controlled clinical trial. Participants will be randomized to receive 8 weeks of neuro meditation in one of two conditions: neuromeditation: Neurofeedback HEG Neurobots and Mindfulness - NHNM verum (experimental group) and neuromeditation: Neurofeedback HEG Neurobots and Mindfulness - NHNM sham (control group). Assessments will be performed at baseline, at the end of the 8th week, and at follow-up at months 1 and 3. The study will be randomized and double-masked. The allocation ratio will be 1:1. To ensure that the two allocation groups have similar sizes, randomization will occur in random blocks of 4 and 8 participants, ensuring confidentiality in the allocation. The study will be conducted at two University Centers located in the cities of Jaguariúna and Indaiatuba, in the interior of São Paulo. Statistical considerations: The sample calculation indicated a need for 45 participants per group. Anticipating a 10% attrition due to losses and refusals, the sample size was adjusted to include 50 participants per group.Keywords: Mindfulness, Neuromeditation, Hemoencephalography neurofeedback, Mental Health, Stress, Depression, Anxiety, Randomized controlled trial. (AU)