Awareness of Emotional Feelings and Management of Risky Situations

Emotional Regulation Clinical Trial

— COSMOS  

Official title:

Awareness of Emotional Feelings and Management of Risky Situations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545241
• Other study ID #: 2022/718
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Damien GABRIEL, PhD
• Phone: +33 3 81 21 91 48
• Email: dgabriel[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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"

Related Conditions & MeSH terms

• Emotional Regulation
• Risk-Taking

Intervention

Behavioral:
• 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.
• 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)

Locations

Country	Name	City	State
France	CHU Besancon - Clinical Psychiatric Department	Besancon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Plateforme Neuraxess

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART]	Number of blue balloons adjusted with BART after 10 neurofeedback sessions among participants who received the neurofeedback treatment.	Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary	Change in EPs during BART	Amplitude variation of evoked potentials (EPs) detected by electroencephalography (EEG) during the Balloon Analogue Risk Task (BART), assessing risk-taking behavior. Variation will be obtained by comparing records before and after 10 neurofeedback sessions	Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary	Feasibility of controlling brain activity during neurofeedback sessions	Satisfaction assessed by a visual analogue scale (items: "I enjoyed participating in the experiment" ; "I was motivated during the experience" ; "I managed to control the particles by thought" and "I feel more relaxed after session".	Baseline (Day 0), immediately after each neurofeedback sessions (session 1 to session 10) and at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary	Change in BIS-10 scores	Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.	Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary	Change in MCQ scores	Compared scores from the French version of the Monetary Choice Questionnaire (MCQ). The MCQ is a self-rated 27 item questionnaire which assessed the discounting. Delay discounting is the decline in the present value of a reward with delay to its receipt.; Example item: " Would you prefer 25€ today or 75€ in 15 days? " For each item, subjects must choose between a low immediate reward and a higher delayed reward.; Waiting times vary from 7 days to 186 days, and rewards are divided into 3 magnitudes: low (25-35€), medium (50-60€), high (75-85€).; This will allow assessing: the influence of the the magnitude of the difference between the two rewards proposed, the impact of the time on the reward's subjective value (speed at which the reward is devalued over time), reflected in the k index.; This index is calculated separately for each magnitude, and an average index is calculated for each subject.; The more the k index is high, the more the subject is considered impulsive.	Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)