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

November 29, 2023 updated by: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 1
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).
week 1, week 2, week 3, week 4, week 5, week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
week 1 and week 6
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).
week 1 and week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Véronique S Grazioli, PhD, Center for Primary Care and Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

July 9, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-00514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For confidentiality issues and due to the small sample planned in this feasibility pilot study, we do not plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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