An Exploratory Study of Engagement in the "Résonance(s)" Musical and Experiential Immersion Program Among Patients With Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Measuring Participant Engagement in the "Résonance(s)" Program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with a neurodegenerative disorder.
- •Patients currently participating in a music-based cognitive remediation program.
研究组 & 干预措施
Scales and questionnaires
Administration of hetero- and self-administered questionnaires and neuropsychological tests
干预措施: Scales and neuropsychological testing (Other)
结局指标
主要结局
Measuring Participant Engagement in the "Résonance(s)" Program
时间窗: 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.
次要结局
- 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)
- 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).(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).(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).(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).(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).(Baseline, Month 5 and Month 8)