- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07847931
People Experiencing Homelessness and Integrative Medical Care: Implementing Music Therapy, Art Therapy and Mindfulness Meditation Sessions in a Low-Threshold Day-in Center in Lausanne for Greater Health Equity (HoPim)
The goal of this study is to evaluate the feasibility and acceptability of implementing group sessions of music therapy, art therapy and mindfulness meditation in real-life setting in a specific context (in a low threshold day-center for people experiencing homelessness in Lausanne "L'Espace"). The second aims consists of exploring participants' experience of these implemented approaches and describe participants' trajectories in terms of health-related QoL, psychological distress, perception of pain, self-esteem and relation to others over time.
The sessions will be implemented sequentially in three blocks:
- Music therapy: 8 biweekly 2 hours sessions over 4 months (group of 8-12 participants);
- Art therapy: 8 biweekly 2 hours sessions over 4 months (group of 8 12 participants);
- Mindfulness meditation: two consecutive 8-week program (weekly 2 hours sessions, group of 8-12 participants).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Participants who provide informed written consent will complete questionnaires at baseline (T0; inclusion), one month (T1), at the end of the sessions' block (T2) and at 8 months (T3). The questionnaire will assess secondary endpoints outlined above. Questionnaires will be hetero-administrated. A T2, semi-structured interviews will be conducted with participants and practitioners to explore perceived benefits, acceptability and implementation experience.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Véronique S. Grazioli, PHD
- Numero di telefono: +41 079 556 11 66
- Email: veronique.grazioli@unisante.ch
Luoghi di studio
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Canton of Vaud
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Lausanne, Canton of Vaud, Svizzera, 1011
- Center for Primary Care and Public Health
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Being ≥18;
- Being fluent in the languages known by the practitioners (English and French for music therapy and art therapy, Franch for mindfulness meditation);
- Planning to stay in Lausanne for the next 10 months;
- Agreeing to participate in group sessions;
- Being homeless according to the categories 1, 2, 3, or 5 of the ETHOS Light typology.
Exclusion Criteria:
- Being unable to provide an informed consent.
- For all interventions: having an unstable mental health issue (actively suicidal depression, active PTSD, decompensated bipolar, acute psychotic episode).
- For the mindfulness meditation blocks only: being in psychological decompensation (including schizophrenia, bipolar disorder, addictive disorders, and suicidal thoughts); suffering from epilepsy, complex trauma or unstable PTSD.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Music therapy, Art therapy, Mindfulness Meditation
Participants will sequentially receive three interventions: music therapy, art therapy, and mindfulness meditation. The interventions will be implemented in a low-threshold drop-in center for people experiencing homelessness in Switzerland. Feasibility and acceptability of implementing these interventions in a real-life setting will be evaluated. |
The music therapy sessions will offer sensory workshops of immersive musical listening, digital and acoustic music creation and shared improvised music. Art therapy sessions will include activities combining painting, modeling, and movement based on an initial theme. Mindfulness meditation sessions will involve foundational practices designed to enhance participants' ability to focus attention on a chosen object, such as the breath, while observing when the mind wanders and gently bringing attention back to the object of focus. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Acceptance rate
Lasso di tempo: Throughout the recruitment period, up to 1 month
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The acceptability (acceptance rate) will be assessed in terms of recruitment rate (#people included/#people invited). |
Throughout the recruitment period, up to 1 month
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Attendance rate
Lasso di tempo: From enrollment through 4 months for music therapy and art therapy; and from enrollment through 2 months for mindfulness meditation
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The feasibility of implementing music therapy, art therapy, and mindfulness meditation in a real-life setting will be assessed in terms of attendance at intervention sessions (number of sessions attended/total number of sessions offered). |
From enrollment through 4 months for music therapy and art therapy; and from enrollment through 2 months for mindfulness meditation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health related quality of life
Lasso di tempo: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
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Health related quality of life will be assessed with a subscale of the World Health Organization Quality of Life - Brief Version, Physical Health Domain (WHOQOL-BREF); range 0-100, with higher scores indicating better health-related quality of life (better outcome). Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation |
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
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Relatedness to others
Lasso di tempo: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
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Relatedness to others will be assessed with a subscale of the Basic Psychological Need Satisfaction Scale (BPNSS); range 1-7, with higher scores indicating greater psychological need satisfaction (better outcome). Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation |
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
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Psychological distress
Lasso di tempo: Baseline, 1 month, and 4 months for music therapy and art therapy; and baseline, T1 (1 month), T2 (2 months) for mindfulness meditation
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Psychological distress will be assessed with the Kessler Psychological Distress Scale (K6); range 0-24, with higher scores indicating greater psychological distress (worse outcome). Questionnaires will be administered at T0 (baseline), T1 (1 month), T2 (4 months) for music therapy and art therapy; and at T0 (baseline), T1 (1 month), T2 (2 months) for mindfulness meditation |
Baseline, 1 month, and 4 months for music therapy and art therapy; and baseline, T1 (1 month), T2 (2 months) for mindfulness meditation
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Self-esteem
Lasso di tempo: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
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Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES); range 0-30, with higher scores indicating higher self-esteem (better outcome). Questionnaires will be administered at T0 (baseline), T1 (1 month), and T2 (4 months) for music therapy and art therapy, and at T0 (baseline), T1 (1 month), and T2 (2 months) for mindfulness meditation. |
Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Maddock A, Hevey D, Eidenmuller K. Mindfulness training as a clinical intervention with homeless adults: A pilot study. International Journal of Mental Health Addiction. 2017;15:529-544.
- Grazioli VS, Hangartner E, Bodenmann P, Schaad L, Grosjean L, Nikles J, Campbell DJT, Hyvert L, Varela TA, Collins SE, Leblanc C, Loignon C, Berna C. Complementary medicine among individuals experiencing homelessness in Switzerland: a quantitative and qualitative descriptive study. BMC Complement Med Ther. 2025 May 6;25(1):166. doi: 10.1186/s12906-024-04727-4.
- Stadler, G., et al., Diversified innovations in the health sciences: Proposal for a Diversity Minimal Item Set (DiMIS). Sustainable Chemistry and Pharmacy, 2023. 33.
- Vallieres EF, Vallerand RJ. Traduction Et Validation Canadienne-Française De L'échelle De L'estime De Soi De Rosenberg. Int J Psychol. 1990;25(2):305-16. doi:10.1080/00207599008247865
- Furukawa TA, Kessler RC, Slade T, Andrews G. The performance of the K6 and K10 screening scales for psychological distress in the Australian National Survey of Mental Health and Well-Being. Psychol Med. 2003 Feb;33(2):357-62. doi: 10.1017/s0033291702006700.
- Gagné M. The Role of Autonomy Support and Autonomy Orientation in Prosocial Behavior Engagement. Motiv Emot. 1 sept 2003;27(3):199-223. doi:10.1023/A:1025007614869
- Deci EL, Ryan RM. The " What " and " Why " of Goal Pursuits: Human Needs and the Self-Determination of Behavior. Psychol Inq. 1 oct 2000;11(4):227-68. doi:10.1207/S15327965PLI1104_01
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Terapie
- Terapie complementari
- Cura del paziente
- Terapia comportamentale
- Psicoterapia
- Discipline e attività comportamentali
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Terapia comportamentale cognitiva
- Terapie artistiche sensoriali
- Mindfulness
- Arte terapia
- Musicoterapia
Altri numeri di identificazione dello studio
- 2026-00812
- 6071.19 (Altro numero di sovvenzione/finanziamento: Leenaards Foundation)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.
Informazioni su farmaci e dispositivi, documenti di studio
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