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

7 agosto 2026 aggiornato da: Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Toulouse, Francia, 31100
        • Centre Support de Réhabilitation psychosociale de Toulouse
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients with a chronic mental disorder (Global Assessment of Functioning [GAF] score > 50).
  • Male or female participants aged over 18 years and under 60 years.
  • Receiving regular psychiatric follow-up.
  • Clinically stable (no full-time psychiatric hospitalization within the previous 6 months).
  • No changes to maintenance antipsychotic treatment (medication and/or dosage) during the previous 3 months.
  • Able and willing to provide written informed consent to participate in the study.
  • Affiliated with or entitled to a national health insurance scheme Patients under legal guardianship, curatorship, or judicial protection measures are eligible for inclusion.

Exclusion Criteria:

  • Patients with a neurodegenerative disorder.
  • Patients currently participating in a music-based cognitive remediation program.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Scales and questionnaires
Administration of hetero- and self-administered questionnaires and neuropsychological tests
Altro: Scales and neuropsychological testing
Administration of hetero- and self-administered questionnaires and neuropsychological tests

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measuring Participant Engagement in the "Résonance(s)" Program
Lasso di tempo: through study completion, an average of 11 months
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.
through study completion, an average of 11 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: Month 5
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.
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).
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: Baseline, Month 5 and 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).
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).
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: Baseline, Month 5 and 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.
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).
Lasso di tempo: 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.
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).
Lasso di tempo: Baseline, Month 5 and 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).
Baseline, Month 5 and Month 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

17 ottobre 2026

Completamento primario (Stimato)

3 settembre 2027

Completamento dello studio (Stimato)

15 ottobre 2027

Date di iscrizione allo studio

Primo inviato

22 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-A01417-44

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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