NCT07762079

Brief Summary

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

July 22, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

rehabilitationmusic

Outcome Measures

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.

    through study completion, an average of 11 months

Secondary Outcomes (10)

  • 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)

    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).

    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).

    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).

    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).

    Baseline, Month 5 and Month 8

  • +5 more secondary outcomes

Study Arms (1)

Scales and questionnaires

OTHER

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

Other: Scales and neuropsychological testing

Interventions

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

Scales and questionnaires

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Support de Réhabilitation psychosociale de Toulouse

Toulouse, 31100, France

Location

MeSH Terms

Interventions

Weights and MeasuresNeuropsychological Tests

Intervention Hierarchy (Ancestors)

Investigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Nathalie NB Bouhnoure, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 13, 2026

Study Start (Estimated)

October 17, 2026

Primary Completion (Estimated)

September 3, 2027

Study Completion (Estimated)

October 15, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations