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

Study acronym: IRIS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 10 of 10 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07762079
Lead Sponsor Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie
Conditions
(from sponsor)		 Chronic Mental Disorders
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov