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

2026년 8월 7일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

25

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 프랑스
      • Toulouse, 프랑스, 31100
        • Centre Support de Réhabilitation psychosociale de Toulouse
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Scales and questionnaires
Administration of hetero- and self-administered questionnaires and neuropsychological tests
다른: Scales and neuropsychological testing
Administration of hetero- and self-administered questionnaires and neuropsychological tests

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Measuring Participant Engagement in the "Résonance(s)" Program
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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)
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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).
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 17일

기본 완료 (추정된)

2027년 9월 3일

연구 완료 (추정된)

2027년 10월 15일

연구 등록 날짜

최초 제출

2026년 7월 22일

QC 기준을 충족하는 최초 제출

2026년 8월 7일

처음 게시됨 (실제)

2026년 8월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 7일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-A01417-44

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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