A Study of Engagement in the "Résonance(s)" Musical and Experiential Immersion Program Among Patients With Mental Disorders - IRIS

Changes in participants' emotional difficulties, as assessed by the difference in the total score and the six dimension scores of the Difficulties in Emotion Regulation Scale (DERS) at the end of the Résonance(s) program (Month 5) and 3 months after the end of the program (Month 8), compared with baseline (inclusion visit). The DERS is a self-report questionnaire comprising 36 items distributed across six dimensions of emotion regulation difficulties. It provides a total score, calculated from the sum of all items, as well as a score for each of the six dimensions. Higher scores indicate greater difficulties in emotion regulation.

Changes in participants' recovery, as assessed by the difference in the total score on the Questionnaire about the Process of Recovery (QPR) at the end of the Résonance(s) program (Month 5) and 3 months after the end of the program (Month 8), compared with baseline (inclusion visit). The QPR is a 15-item self-report questionnaire designed to assess the recovery process in people with mental health conditions. Recovery is evaluated using the total score, obtained by summing the responses to all 15 items. Higher total scores indicate greater progress in the recovery process.

Engagement in the care pathway will be assessed by the proportion of participants answering "yes" to Question 22 of the end-of-program questionnaire administered at Month 5. The proportion of "yes" responses across all participants will provide an overall indicator of engagement in the Résonance(s) program.

Changes in self-stigma will be assessed by the difference in the total score on the Internalized Stigma of Mental Illness (ISMI) scale at the end of the Résonance(s) program (Month 5) and three months after program completion (Month 8), compared with baseline (inclusion visit). The ISMI is a 29-item self-report questionnaire, with each item rated on a 5-point Likert scale (0-4). It provides a total score as well as five subscale scores, corresponding to the different dimensions of internalized stigma. Higher scores indicate greater levels of self-stigma.

Changes in self-esteem will be assessed by the difference in the Self-Esteem Rating Scale (SERS) scores at the end of the Résonance(s) program (Month 5) and three months after program completion (Month 8), compared with baseline (inclusion visit). The SERS is a 20-item self-report questionnaire comprising 10 positively worded items and 10 negatively worded items. Self-esteem is assessed using the overall score, calculated according to the scoring guidelines for the scale. Higher overall scores indicate better global self-esteem.

Changes in attentional functioning will be assessed using the Crossmodal Comparison subtest of the Test of Attentional Performance (TAP). This subtest explores intermodal comparison abilities, processing speed, selective attention, and inhibitory control mechanisms involved in sensory information processing. The mean, median, standard deviation, and the number of errors and omissions will be compared between the end of the Résonance(s) program (Month 5), three months after program completion (Month 8), and baseline (inclusion visit).

Changes in social cognition will be assessed using the total score obtained on the Emotional Fluency Test from the Bordeaux Social Cognition Assessment Protocol (PECS-B) at the end of the Résonance(s) program (Month 5) and three months after program completion (Month 8), compared with baseline (inclusion visit). The PECS-B is composed of six tasks assessing four dimensions of social cognition: emotional lexicon, emotion recognition, theory of mind, and alexithymia. These dimensions are evaluated through total scores, with changes in scores used to assess variations in social cognitive abilities over time.

Changes in anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI is a 20-item self-report questionnaire, with each item rated on a 4-point scale (1-4). Higher scores indicate higher levels of anxiety. State anxiety (STAI Form Y-A), which evaluates the participant's current emotional state and situational anxiety, will be measured at each program session to monitor changes over time. Trait anxiety (STAI Form Y-B), which assesses the participant's usual and more stable emotional disposition toward anxiety, will be assessed at baseline (inclusion visit), at the end of the program (Month 5), and three months after program completion (Month 8) to evaluate changes in the participant's habitual anxiety level.

Participants' experiential perceptions of the Résonance(s) program will be described using responses to all items of the end-of-program questionnaire (Month 5), excluding the item related to engagement in the care and recovery pathway. Responses to these items will be collected as "yes" or "no" answers and will assess participants' appreciation and perception of the program. Each questionnaire item will be summarized using descriptive analyses.

Changes in psychotropic medication, including dosage adjustments and any changes in prescribed medication, will be described at Month 5 and Month 8 in comparison with baseline (inclusion visit).