Clinical trial NCT05545241: Awareness of Emotional Feelings and Management of Risky Situations
Official title: Awareness of Emotional Feelings and Management of Risky Situations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk-Taking
Emotional Regulation
Keywords: risk-taking
emotional neurofeedback
emotional regulation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Plateforme Neuraxess
First posted: 2022-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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"

Primary outcomes:
measure: Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART]
timeFrame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary outcomes:
measure: Change in EPs during BART
timeFrame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
measure: Feasibility of controlling brain activity during neurofeedback sessions
timeFrame: Baseline (Day 0), immediately after each neurofeedback sessions (session 1 to session 10) and at the study completion (after 10 neurofeedback sessions, Week 5)
measure: Change in BIS-10 scores
timeFrame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
measure: Change in MCQ scores
timeFrame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon - Clinical Psychiatric Department
Study officials:
References: