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Completed

NCT Number: NCT05873491

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

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.

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Key information

Conditions

Homelessness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Primary Care and Public Health

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

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

Primary outcomes

  1. Music therapy acceptability

    Time frame: week 1

    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.

  2. Music therapy feasibility

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

    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).

Secondary outcomes

  1. Appropriateness of psychological distress outcome for future clinical trials

    Time frame: week 1 and week 6

    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).

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

    Time frame: week 1 and week 6

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

Sponsors and collaborators

Lead sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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