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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFederation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients with a neurodegenerative disorder.

Patients currently participating in a music-based cognitive remediation program.

Trial design

Design model

Single group

Treatments tested in this trial

  • Scales and neuropsychological testing

    Other intervention

    Administration of hetero- and self-administered questionnaires and neuropsychological tests

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Scales and questionnairesOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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