- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Véronique S. Grazioli, PHD
- Número de teléfono: +41 079 556 11 66
- Correo electrónico: veronique.grazioli@unisante.ch
Ubicaciones de estudio
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Canton of Vaud
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Lausanne, Canton of Vaud, Suiza, 1011
- Center for Primary Care and Public Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptance rate
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health related quality of life
Periodo de tiempo: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
|
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
|
|
Relatedness to others
Periodo de tiempo: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
|
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
|
|
Psychological distress
Periodo de tiempo: Baseline, 1 month, and 4 months for music therapy and art therapy; and baseline, T1 (1 month), T2 (2 months) for mindfulness meditation
|
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
|
|
Self-esteem
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Terapéutica
- Terapias complementarias
- Atención al paciente
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia cognitiva conductual
- Terapias de arte sensorial
- Consciencia
- Terapia de arte
- Musicoterapia
Otros números de identificación del estudio
- 2026-00812
- 6071.19 (Otro número de subvención/financiamiento: Leenaards Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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