Clinical trial NCT05873491: Homeless People in French-speaking Switzerland and Integrative Medicine: A Pilot Intervention in Music Therapy
Official title: Homeless People in French-speaking Switzerland and Integrative Medicine: A Pilot Intervention in Music Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homelessness
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include homeless adults in French-speaking Switzerland.

Brief summary: The goal of this observational study is to evaluate the feasibility to develop and implement a music therapy intervention among homeless individuals in French-speaking Switzerland.

The main questions it aims to answer are:

* Are the music therapy sessions acceptable?
* Are the music therapy sessions feasible?
* Are the chosen effectiveness primary outcomes appropriate for future larger studies (i.e., health-related quality of life and psychological stress)?

Participants will take part in six sub-group (of 6 participants) 2-hours music therapy sessions over 6 weeks. The sessions will be conducted by a certified music therapist and will offer sensory workshops of immersive musical listening, digital and acoustic music creation and shared improvised music. The music therapy sessions aim to create a space for sound and relaxation; promote the emergence of creativity and improvements in social skills and self-esteem through the co-construction of a privileged space for musical interaction.

Detailed description: Study procedures:

The research team will recruit homeless service users within low-threshold institutions for homeless people in Lausanne and conduct the informed consent process. Participants agreeing to participate and providing written informed consent will complete a hetero-administrated paper-pencil questionnaire before receiving the first intervention session (T0). Parts of the dimensions assessed with this questionnaires (i.e., outcomes) will be reassessed after receiving the 6 music therapy sessions (T1).

At T0, the questionnaire will measure participants' demographics, health-related quality of life (QoL), psychological stress levels and self-esteem. Questionnaire completion will last between around 30 minutes each, depending on the support needed by the participants.

At T1, participants will complete a second questionnaire (T1). This questionnaire will assess the same dimensions than the ones at T0 except demographics and will also evaluate participants' satisfaction regarding the intervention sessions.

Quantitative assessment will be completed by qualitative evaluation through field observation during the 6 music therapy sessions by the research team. At T1, trained research staff will conduct one-on-one semi-structured interviews with the participants as well as with the music therapist. This qualitative assessment will aim at exploring therapist and participants' experience of the music therapy sessions. The semi-structured interview will last 30-60 minutes.

Eligibility criteria: Inclusion Criteria:

* Being ≥18 ;
* Being fluent in French;
* Planning to stay in Lausanne the next 6 weeks;
* Committing to take part in as many as possible of the music therapy sessions;
* Agreeing to participate in group session;
* Being homeless according to the categories 1, 2, 3, or 5 of the ethos-light typology (Baptista \& Marilier, 2019):

Living rough (i.e., public spaces); In emergency accommodation (i.e., overnight shelters); Living in accommodation for the homeless (i.e., temporary accommodation); Living in non-conventional dwellings due to lack of housing (i.e., mobile homes; non-conventional buildings);

Exclusion Criteria:

* Being unable to provide an informed consent.

Primary outcomes:
measure: Music therapy acceptability
timeFrame: week 1
measure: Music therapy feasibility
timeFrame: week 1, week 2, week 3, week 4, week 5, week 6
Secondary outcomes:
measure: Appropriateness of psychological distress outcome for future clinical trials
timeFrame: week 1 and week 6
measure: Appropriateness of quality of life outcome for future clinical trials
timeFrame: week 1 and week 6
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Center for Primary Care and Public Health
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health
name: Véronique S Grazioli, PhD
role: PRINCIPAL_INVESTIGATOR
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