Awareness of Emotional Feelings and Management of Risky Situations

NCT ID: NCT05545241

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-09-15

Brief Summary

The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.

Detailed Description

All emotions such as sadness, anger, fear or joy undoubtedly have an important place in our lives. Our emotions influence all areas of our lives and particularly our relationships: with our spouses, our friends, our children, our colleagues. Emotions are necessary for our decisions. By influencing our decisions, emotions automatically impact our performance.

By guiding our choices, our emotions lead us to take risks. Taking risks is sometimes essential to a suitable decision. But this risk-taking must not result from an inappropriate decision-making process. People must therefore adapt their risk-taking, i.e. integrate our emotions into decision-making. It is therefore not a question of ignoring one's emotions, but of regulating them in order to be in a state favorable to action. This awareness of emotional feelings would help develop the ability to produce good internal feedback.

The purpose of COSMOS project is to help individuals better self-assess by taking advantage of their emotional feelings. To do this, investigators will teach individuals to detect and manage their emotions using an emotional neurofeedback device developped by the Neuraxess platform (a functional neuroimiaging and neurostimulation platform, located in Besancon, France). Neurofeedback is a type of biofeedback, namely a rehabilitation method based on the subject's awareness of physiological processes, during which the neuronal activity of an individual is measured and presented to him in real time, here in artistic form. The goal of this method is that the individual manages to self-regulate his neuronal activity supposed to underlie a specific behavior. So, over time, the participant might be able to learn how to voluntarily control the activation of their cerebral cortex in order to regulate their emotions and behaviors in everyday life. Here, by learning to detect and manage their emotions, participants will be able to take more appropriate risks. The balloon test (Balloon Analogue Risk Task or BART) is used to measure risk taking. This tasks consists of inflating a balloon by clicking on a button on the computer. The more the balloon inflates, the more money participants earn, but the involved risk is to reach a threshold where the balloon bursts and participants lose everything. Participants have the choice between reaching the limit and losing everything or controlling ourselves and recovering our gains before the disaster. This is a simple test but it closely matches the behavior of the player at a poker or roulette table in a casino. Participants' risk-taking will be assessed before the emotional neurofeedback sessions and then after 10 sessions.

Conditions

Risk-Taking; Emotional Regulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Neurofeedback and BART-EEG assessment

Healthy subjects realized 10 sessions of emotional neurofeedback. Before (Baseline, Day 0), and after (at the study completion (after 10 neurofeedback sessions, Week 5)) neurofeedback sessions, the BART, assessing risk-taking behavior, coupled with an EEG record is realized by the subjects.

Group Type: EXPERIMENTAL

Neurofeedback + BART/EEG

Intervention Type: BEHAVIORAL

10 sessions of emotional neurofeedback (max of 2 sessions per week and max of 10 weeks).

Before (Baseline, Day 0) and at the study completion (after 10 neurofeedback sessions, Week 5), a EEG record is realized during the BART, assessing risk-taking behavior.

BART-EEG assessment without neurofeedback

At the same times (Baseline, Day 0), and at the study completion (after 10 neurofeedback sessions, Week 5), healthy subjects realized the BART, assessing risk-taking behavior, coupled with an EEG record.

Group Type: SHAM_COMPARATOR

BART/EEG only

Intervention Type: BEHAVIORAL

only the twice EEG record are realized during the BART, assessing risk-taking behavior (every corresponding to the pre and post-neurofeedback evaluations in arm I)

Interventions

Neurofeedback + BART/EEG

10 sessions of emotional neurofeedback (max of 2 sessions per week and max of 10 weeks).

Before (Baseline, Day 0) and at the study completion (after 10 neurofeedback sessions, Week 5), a EEG record is realized during the BART, assessing risk-taking behavior.

Intervention Type: BEHAVIORAL

BART/EEG only

only the twice EEG record are realized during the BART, assessing risk-taking behavior (every corresponding to the pre and post-neurofeedback evaluations in arm I)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjects between 18 and 80 years old
• Right-handed
• Signed informed Consent Form
• Subject affiliated to or beneficing from a French social security regime

Exclusion Criteria

• Subjects under 18 years old and over 80 years old
• Left-handed
• Pregnant woman
• Subject beneficiary from a legal protection regime
• Subject unlikely to cooperate or low cooperation stated by investigator
• Subject not covered by social security
• Subject being in the exclusion period of another study or provided for by the "National Volunteer File"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Plateforme Neuraxess

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Besancon - Clinical Psychiatric Department

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Damien GABRIEL, PhD

Role: CONTACT

dgabriel@chu-besancon.fr

+33 3 81 21 91 48

Magali NICOLIER, PhD

Role: CONTACT

mnicolier@chu-besancon.fr

+33 3 81 21 90 07

Other Identifiers

2022/718

Identifier Type: -

Identifier Source: org_study_id