Emotional Regulation Clinical Trial
— COSMOSOfficial title:
Awareness of Emotional Feelings and Management of Risky Situations
The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.
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" |
Country | Name | City | State |
---|---|---|---|
France | CHU Besancon - Clinical Psychiatric Department | Besancon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon | Plateforme Neuraxess |
France,
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) |
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