- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Véronique S. Grazioli, PHD
- Numer telefonu: +41 079 556 11 66
- E-mail: veronique.grazioli@unisante.ch
Lokalizacje studiów
-
-
Canton of Vaud
-
Lausanne, Canton of Vaud, Szwajcaria, 1011
- Center for Primary Care and Public Health
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Acceptance rate
Ramy czasowe: Throughout the recruitment period, up to 1 month
|
The acceptability (acceptance rate) will be assessed in terms of recruitment rate (#people included/#people invited). |
Throughout the recruitment period, up to 1 month
|
|
Attendance rate
Ramy czasowe: From enrollment through 4 months for music therapy and art therapy; and from enrollment through 2 months for mindfulness meditation
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Health related quality of life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline, 1 month, and 4 months for music therapy and art therapy; baseline, 1 month, and 2 months for mindfulness meditation
|
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
|
Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-00812
- 6071.19 (Inny numer grantu/finansowania: Leenaards Foundation)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .