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CompletedNCT05873491Updated Nov 30, 2023

Homeless People in French-speaking Switzerland and Integrative Medicine: A Pilot Intervention in Music Therapy

An observational study in Homelessness, sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Homelessness
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In context

Lead sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population will include homeless adults in French-speaking Switzerland.

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

Exclusion Criteria:

  • Being unable to provide an informed consent.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Interventions

  • OtherMusic therapy

    The music therapy sessions will offer sensory workshops of immersive musical listening, digital and acoustic music creation and shared improvised music.

06

What researchers measure

Primary outcomes

  1. Music therapy acceptability

    Acceptability will be measured based on the recruitment level (#included participants/#invited individuals). Specifically, we will monitor the number of participants invited to participate in the study and the acceptability outcome will be computed by dividing the number of participants who were included in the study by the number of participants who were invited to participate in the study.

    Time frame: week 1

  2. Music therapy feasibility

    Feasibility will be measured based on participants' sessions participation level (#attended session/#total sessions). Specifically, we will monitor music therapy sessions attendance at week 1, 2, 3, 4, 5 and 6 for each included participants and the feasibility outcome will be computed by dividing the number of attended sessions by the total number of offered sessions (i.e., 6).

    Time frame: week 1, week 2, week 3, week 4, week 5, week 6

Secondary outcomes

  1. Appropriateness of psychological distress outcome for future clinical trials

    In line with similar past pilot research among homeless individuals (Gaddy, 2018; Garland et al., 2016; Maddock et al., 2017), this questionnaire will evaluate psychological distress with the Kessler Psychological Distress Scale (K6) (Furukawa et al., 2003).

    Time frame: week 1 and week 6

  2. Appropriateness of quality of life outcome for future clinical trials

    Perceived QoL using the World Health Organization Quality of Life-BREF (Skevington et al., 2004).

    Time frame: week 1 and week 6

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Study locations

1 site
  • Center for Primary Care and Public Health
    Lausanne, Vaud 1011, Switzerland
08

References and documents

Publications

  • Gaddy MA. Implementation of an integrative medicine treatment program at a Veterans Health Administration residential mental health facility. Psychol Serv. 2018 Nov;15(4):503-509. doi: 10.1037/ser0000189. Epub 2017 Oct 12. PubMed 29022737 ↗
  • Maddock, A., D. Hevey, and K. Eidenmuller, Mindfulness training as a clinical intervention with homeless adults: A pilot study. International Journal of Mental Health Addiction, 2017. 15: p. 529-544.
  • 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. PubMed 15085902 ↗
  • 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. PubMed 12622315 ↗
  • Baptista, I. and E. Marilier, Fighting homelessness and housing exclusion in Europe: A study of national policies, E.S.P.N. (ESPN), Editor. 2019: Brussels: European Commission.
  • Garland EL, Roberts-Lewis A, Tronnier CD, Graves R, Kelley K. Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial. Behav Res Ther. 2016 Feb;77:7-16. doi: 10.1016/j.brat.2015.11.012. Epub 2015 Nov 27. Erratum In: Behav Res Ther. 2018 Jan;100:78. doi: 10.1016/j.brat.2017.09.007. PubMed 26701171 ↗

Individual participant data

Plan to share: No — For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05873491
Lead sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Responsible party
Sponsor
First posted
May 24, 2023
Start date
May 22, 2023
Primary completion
Jul 9, 2023
Completion
Aug 31, 2023
Last update
Nov 30, 2023

Study contacts

Véronique S Grazioli, PhD
principal investigator · Center for Primary Care and Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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