An interventional study of Scales and neuropsychological testing in Chronic Mental Disorders, sponsored by Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie · Not applicable, Interventional, and Other
The objective of this exploratory, interventional, single-center study without a control group is to examine participation in the "Résonance(s)" musical and experiential immersion program among patients aged 18 to 60 with a chronic, stabilized mental health condition who are receiving outpatient care. The main research question it aims to answer is as follows:
Do participants with a mental health disorder actively engage in the Résonance(s) program-that is, do they attend at least 70% of the 11 sessions scheduled in the program (rehearsals with the Orchestre national du Capitole de Toulouse, music listening sessions, and the final concert)
Participants will take part in the Résonance(s) program for 4 months (rehearsals, discussions with musicians and caregivers, listening sessions, and a public concert), in addition to their usual standard care. They will be assessed three times-before the start of the program, at the end of the 4-month intervention, and 3 months after the program ends-using clinical interviews and self-administered questionnaires focusing in particular on their emotional well-being, recovery, self-stigmatization, self-esteem, attentional abilities, social cognition, and anxiety. The total duration of participation for each patient is 8 months, with the overall study lasting 11 months (including the 3-month enrollment period), and a recruitment goal of 25 patients.
The IRIS protocol is part of an evaluation of the program, with the primary objective of measuring participants' engagement in the Résonance(s) program.
The investigator hypothesize that combining musical immersion, discussions with participants (musicians, healthcare providers, and patients), and listening to recordings will foster participants' engagement in the program.
Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of hetero- and self-administered questionnaires and neuropsychological tests
Other: Scales and neuropsychological testing
Administration of hetero- and self-administered questionnaires and neuropsychological tests
Measuring Participant Engagement in the "Résonance(s)" Program
The primary evaluation criterion is the active participation of participants in the "Résonance(s)" program, defined as attendance at at least 70% of the scheduled sessions-that is, at least 8 of the 11 sessions included in the program.
Time frame: through study completion, an average of 11 months
To measure the impact of the "Résonance(s)" program on the emotional well-being of participants at the end of the program (Month 5) and three months after the end of the program (Month 8)
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.
Time frame: Baseline, Month 5 and Month 8
To measure the impact of the "Résonance(s)" program on participants' recovery, immediately after the end of the program (Month 5) and three months after the end of the program (Month 8).
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.
Time frame: Baseline, Month 5 and Month 8
To assess the impact of the Résonance(s) program on participants' engagement in their recovery-oriented care pathway at the end of the intervention (M5).
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.
Time frame: Month 5
To assess the impact of the Résonance(s) program on participants' self-stigma immediately after completion of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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.
Time frame: Baseline, Month 5 and Month 8
To assess the impact of the Résonance(s) program on participants' self-esteem immediately after completion of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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.
Time frame: Baseline, Month 5 and Month 8
To assess the impact of the Résonance(s) program on participants' attentional functions immediately after completion of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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).
Time frame: Baseline, Month 5 and Month 8
To assess the impact of the Résonance(s) program on participants' social cognition immediately after completion of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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.
Time frame: Baseline, Month 5 and Month 8
To assess the impact of the Résonance(s) program on participants' anxiety immediately after completion of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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.
Time frame: Baseline, Month 5 and Month 8
To describe the experiential perceptions of participants in the Résonance(s) program at the end of the intervention (Month 5).
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.
Time frame: Month 5
To describe changes in participants' psychotropic medications at the end of the intervention (Month 5) and three months after the end of the intervention (Month 8).
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).
Time frame: Baseline, Month 5 and Month 8
Plan to share: No
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Started Oct 2026 (actual). Primary completion is estimated for Sep 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie